The cost of doing nothing
15–20%
of sales revenue is commonly lost to the cost of poor quality. Scrap, rework, retest, absorbed claims and the hours spent rebuilding context.
ASQ, cost of quality resourcesRead
Solutions/iQM Quality Management
Quality decisions belong where the work happens.
Deviations, complaints, CAPA, change control, risk, tasks and samples run on the same orders, batches and suppliers they affect—standalone or connected to your systems. Every workflow is configured to your products and transactions. Not every quality problem needs AI.
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iQM QUALITY MANAGEMENT
Quality decisions belong where the work happens.
One-page brochure
Problems, value, standards and how to start
zeakCUSTOMER OVERVIEW
7 MODULES · 197 FEATURES
iQM Quality Management
Customer overview
Every feature, the value method and how a pilot works
- Production-ready
- Deployed in your cloud
- SOC 2 & ISO 27001 controls
- GDPR-aligned
- D365 · SAP · Oracle · NetSuite · any system
The business case
The costliest failures are the ones nobody could trace in time.
A wafer lot, a flight-critical part, a returned order or a drug batch—the expensive part is the same: finding what was affected, who received it, which supplier caused it and whether the fix worked.
Quality failures stop supply
CAPA and complaint handling are the two most-cited quality-system sections in FDA device inspections. The fix that never reaches the process is the finding that comes back.
Every industry has a number
$26–36B
yearly cost of poor quality in medical devices (McKinsey)
$10M
average direct cost of a food recall (FMI and GMA)
$743B
merchandise returned to US retailers in a year (NRF)
1,800+
suspect counterfeit electronic-part cases in US defense supply (US Senate)
Different industries, the same need: the quality record has to know what it affected.
Full sources in the customer overviewSee sources
Waiting isn't neutral. Every month quality lives apart from the work is a month of context rebuilt by hand, supplier claims missed and fixes that never reach the process.
External research benchmarks, not Zeak customer results or promised returns. Survey populations, methods and use cases differ.
Key benefits
Six quality problems. A proof you can check for each.
Every proof comes from your own data.
Close quality events faster
Quality events live apart from the work
Deviations and complaints sit in spreadsheets, paper or a separate system, cut off from the order, batch and supplier.
With Zeak: Raised on the order, batch, lot or supplier they affect, with the context captured when it happens.
Proof you can checkEvents linked to batch, order or supplierInvestigations cross too many teams
Quality, production, supply chain and suppliers pass the record around by email.
With Zeak: Owned tasks, due dates and escalations; every team works on the same record.
Proof you can checkDeviation and CAPA cycle timeThe same problem keeps coming back
A local fix never reaches the process, the specification or the supplier.
With Zeak: CAPA linked to the cause, governed change control and effectiveness checks.
Proof you can checkRepeat deviations after a CAPA
Stay in control and audit-ready
One workflow does not fit every product
Sterile and non-sterile, raw material and finished goods, all forced through the same steps.
With Zeak: Every workflow configured by product category, transaction type, site and severity—without code.
Proof you can checkWorkflows changed without a releaseProving compliance takes days
Evidence for an audit or inspection is assembled by hand.
With Zeak: Electronic records and signatures where required, an append-only trail and evidence exported on demand.
Proof you can checkHours to evidence an audit sampleA risk register nobody trusts
Risk files are updated once a year, if at all.
With Zeak: A risk file every module keeps current from live deviations, complaints, samples and changes.
Proof you can checkRisks updated from live events
What it is worth
We don't lead with a savings number. We measure yours.
Poor quality costs money in six places, and the quality budget shows only some of them. We measure each one with your records—and Quality and Finance sign the baseline before anything changes.
Where the cost sitsWith iQMMeasured as
01
Record admin and re-keying
Batch, order, supplier and SOP filled in from your systems; one task list instead of email chasing.
Records a year × admin hours each × loaded rate
02
Held batches and slow release
Investigations start with the batch, stage, SOP revision and supplier already on the record.
Held batches × extra hold days × cost of a hold day
03
Repeat failures
CAPA linked to governed change and effectiveness checks, so the fix reaches the process.
Recurring events × rework, scrap and retest per event
04
Cost absorbed instead of recovered
Supplier, transport and third-party claims recorded on the complaint, with the evidence attached.
Claims not filed or lost × average claim value
05
Inspection and audit effort
Numbered, routed and signed records, with evidence exported on demand.
Audits a year × hours to prepare × rate, plus remediation
06
External failures
Lot traceability, complaints to CAPA, and recalls and mock recalls on the lot.
Events traced to quality × cost per event
Six steps, two weeks, your own numbers
Part of Discover- 1Count the recordsDeviations, CAPAs, complaints, changes and samples a year, by site
- 2Measure the adminWho touched 10–20 recent records, for how long, and what was re-keyed
- 3Measure hold and cycle timeDays from event to closure; days batches waited for a decision
- 4Count repeats and recoveriesEvents that recurred; claims filed, lost or never raised; credits received
- 5Price audit and external failureHours per audit; complaints, returns and recalls traced to quality
- 6Agree it with Quality and FinanceSign the baseline before anything changes
How payback is calculatedPayback in weeks = first-year cost ÷ measured weekly valueThe cost comes from your proposal. The value comes from your pilot. Neither comes from an industry average.
Plus the build you don't fundNo ERP quality build to commission, and no custom code to retest and re-validate at every ERP update—before any saving is counted.For context: whole ERP projects show a median cost of $450,000 and a median timeline of 9 months (Panorama Consulting, 2025 ERP Report).
Value Finance can stand behind.Baseline signed firstRecovered means receivedEach benefit counted onceNever built on headcount reduction
If the pilot doesn't show value on your own records, you stop—and you keep everything you learned.
Built around your decisions
One quality record. Every team's decision on it.
Quality & regulatory
VP Quality · QA managers · Regulatory
Controlled, connected and inspection-ready.
See open CAPAs, deviations and complaints by status and age, changes awaiting approval, and reporting deadlines.
Measured on
Overdue CAPAsRepeat findingsDeadlines met
- Every CAPA linked to its source and to the change that fixed it
- Regulatory reports, deadlines and alerts on the complaint
- Numbered, signed records an inspector can follow end to end
Operations
Plant directors · Production · Investigators
The context is already on the record.
Deviations and samples sit on your production orders and batches, with batch, stage, SOP revision and supplier filled in.
Measured on
Batches heldDeviations per batchInvestigation time
- Deviations raised on the production order, batch and stage
- Batch hold and disposition with material review
- Root cause with 8D and other methods, and effectiveness checks
Supplier quality
Procurement · Supplier quality managers
Supplier-caused cost, claimed and recovered.
Vendor, transport and third-party claims are recorded on the complaint with batch and PO evidence already attached.
Measured on
Claims filedValue recoveredIncoming sample failures
- Vendor, transport and other claims on the complaint
- Supplier corrective actions and certificates of analysis
- Supplier risk from Zeak Supplier Intelligence in the same register
Risk & engineering
Risk owners · FMEA owners · Quality engineers
A risk file that stays current.
Complaints, deviations, CAPA results, samples and changes post signals to the risks they touch; you re-assess with the evidence in front of you.
Measured on
Open high risksMitigations on timeRisks updated from events
- Matrix, FMEA, ISO 14971 and HACCP methods
- Risk assessed on every change, before and after
- A risk raises a governed change, with its owner carried across
Finance
CFO · Controllers
Quality value you can put in the forecast.
Change cost is controlled with budgets; cost of poor quality is measured from your ledger and supplier cost is recovered.
Measured on
Cost of poor qualityClaims recoveredChange cost vs. budget
- Budget and currency control on every change
- Cost on every CAPA; claim value tracked to the credit received
- SOX and J-SOX evidence where quality events change inventory value
IT & platforms
CIO · ERP and platform owners
Your cloud. Your systems of record.
Run standalone or connect to the systems you already operate. Start read-only; switch on write-back object by object.
Measured on
Data freshnessAccess reviewsRelease health
- Your cloud tenant or the Zeak cloud, under your identity provider
- Connectors versioned and tested against supported releases
- Every record and audit entry exportable in open formats
Key features
Seven connected processes. Configured your way.
Change control, CAPA, deviations, complaints, tasks, risk and samples share one platform layer—audited on every transaction, signed where your procedures require it, and connected to the systems you already run.
197 features across 7 modules and one platform layer
Open any module to see what each feature does and what you get from it.
Business benefitEvery change governed, routed and verified, with its cost in view.Quality · Regulatory · Engineering · Finance
Change requestsYour team raises a change with a reason, description, category, type, overall impact, priority, an emergency flag and a planned or unplanned classification. Requester, department, request date and estimated completion are recorded, and the system stamps who created it and when.You get: Every change starts as one controlled, attributable record instead of an email.
Work queues by stageSeparate views for Draft, Submitted, Approved, Implemented, Verified, Rejected and Closed changes, each with filtering.You get: Owners and approvers see exactly what is waiting at their stage.
Controlled lifecycleSubmit for approval, recall, approve, reject, revise the proposal, implement, verify and close. Each step is a deliberate action by an authorized user.You get: Approval, execution and verification are recorded as separate control points, which is what auditors look for.
Department approval routingChoose Standard or Custom workflow. Each department can approve in one stage or several, with a primary approver and second and third approvers, and its own member list.You get: Changes reach the people who understand them, without a central bottleneck.
Budget and currency controlSwitch budget control on where change cost matters: set the overrun policy, default and budget currency, exchange-rate type, and the user groups allowed to override.You get: Quality change and financial governance meet in one record.
Numbering your wayAssign the change number sequence, or number changes by department to match existing conventions.You get: Identifiers your organization already recognizes.
Impact assessment typesMaintain the impact-assessment types your changes are assessed against.You get: Assessments use one controlled vocabulary.
Affected-object impactList the items, formulas, routes, resources, vendors and SOPs a change affects, with the impact on each, before approval.You get: Reviewers approve knowing exactly what the change touches.
Implementation task planBreak an approved change into owned, dated tasks in the shared task list.You get: Execution between approval and verification is visible.
Post-change effectiveness checkPlan and record a check that the change achieved its intent before closure.You get: Proof that the change worked, not just that it was done.
Intake defaultsSet default category, type, priority, impact, emergency and planned values, and default completion days from which target dates are calculated.You get: Faster, more consistent intake with fewer keying errors.
Formal change reportsChange or remove the report logo and choose whether approver signatures print on the report.You get: Change records that are ready to file or hand to an auditor.
Reasons on reject and reviseCapture a reason code and comment whenever a change is rejected or sent back.You get: Requesters know why, and the history explains itself.
Linked-records viewSee every CAPA, deviation and risk that points at a change, with its status.You get: Change owners see what depends on their change.
Document and training impactFlag SOPs to revise and roles to retrain, through your document and training systems.You get: Procedures and people catch up with the change.
Change classes and profilesMinor, major and critical changes each get the rigor they need, with separate regulated and non-regulated profiles that can run in the same company.You get: One change process that fits a GMP plant and a distribution center.
Customer and supplier change noticesNotify the customers who bought an affected item, track their acknowledgments, and turn every supplier change notice into a reviewed change.You get: Customers hear about changes on time, and supplier changes never slip in unreviewed.
Changes that update ERPApproved changes launch the BOM, formula, route and vendor updates they need, and the change cannot close until those are effective.You get: What was approved is what the ERP runs.
Label, SDS and registration triggersA formula or packaging change flags every safety data sheet, label, registration and customer specification it touches.You get: Regulated content never lags the product.
Regulatory filing impactRecord what each change means for your registrations in each market, and hold implementation until the approval it needs arrives.You get: No change goes live ahead of its approval.
Multi-site rolloutFollow one approved change through every site that must implement it, each with its own date and verification.You get: Nothing is closed while a site is still on the old process.
Process-safety management of changeA management-of-change variant with hazard review and a pre-startup safety review before anything restarts.You get: Quality and process-safety change in one governed record.
Technology transfer and scale-upRun transfers between sites and contract manufacturers as governed changes with comparability and readiness by site.You get: Transfers that arrive ready to run.
Business benefitCorrective action that remembers where it came from and what it changed.Quality · Investigators · Supplier quality
CAPA recordsOpen a CAPA with a required title and reason code, severity, process status (for example Problem Identification) and the responsible department. Reporter, reported date, creator and creation time are recorded.You get: Every corrective or preventive action is a controlled record with clear ownership.
Link to Change ControlWhen raising a CAPA, link an existing change or choose New Change Control; the change number, description, requester, category and department show on the CAPA.You get: The fix is governed as a change, and the link is on the record.
Source and ERP traceabilityEach CAPA shows where it came from, such as a complaint, with the source document number, and the ERP reference transaction type and transaction.You get: A CAPA can always be traced back to the issue and the transaction that triggered it.
Approval and closure with e-signatureApprove, return for update, reopen and close. Administrators can require an electronic signature on approval, on closure, or both.You get: Signed decisions at the two points inspectors check most.
Work queues and searchAll, Favorites, Draft, Reopened, Approved, Needs Update and Closed views, with status filtering and keyword search.You get: Owners find their work, and investigators find similar past cases.
Controlled valuesMaintain reason codes, CAPA categories with impact and probability, and disposition comments. Workflow can be switched on or off.You get: Consistent classification that can be trended.
Root-cause analysisCapture structured root cause with cause codes and link each action to the cause it addresses.You get: Actions aimed at causes, not symptoms.
CAPA from deviations and risksRaise a CAPA directly from a deviation or a risk, with the source recorded.You get: Fewer re-keyed records and a complete source trail.
Action plan roll-upSee corrective, preventive and other actions together, with completion rolled up to the CAPA.You get: One view of progress on every CAPA.
Typed action numberingCorrective, preventive and other CAPA tasks each draw from their own number sequence, alongside shared sequences for related quality records.You get: Corrective and preventive actions stay distinguishable in every report.
Formal CAPA outputsPreview, print or email the CAPA document, with your report logo.You get: Records ready for review boards and auditors.
Effectiveness verificationPlan an effectiveness check with criteria and a due date; closure waits for the result.You get: Evidence that the CAPA worked.
Recurrence detectionFlag new deviations and complaints that match a closed CAPA's product, cause or source.You get: Repeat failures surface before the next inspection.
Phase due dates and escalationSet due dates per CAPA phase and escalate overdue phases.You get: CAPAs keep moving.
8D and problem-solving methodsRun 8D, 5 Whys, fishbone, is / is-not, A3 or DMAIC on the CAPA, and send customers an 8D in the format they expect.You get: Investigations that are consistent inside and accepted outside.
Supplier corrective actionsSend a corrective action request to the supplier and see its response, due date and acceptance on the CAPA.You get: Supplier fixes are tracked like your own.
Cost on every CAPASee what the failure cost and what the fix cost on the CAPA, from your ERP transactions.You get: Corrective action that Finance can value.
Containment that finds every unitBlock affected batches and serials on hand, in transit, at other sites and at customers, from the CAPA.You get: Suspect product stops moving the day the problem is found.
More ways into CAPARaise a CAPA from an audit finding, an OOS result, a failed sample or a supplier event, with the source recorded.You get: Every source of nonconformity reaches corrective action.
Business benefitEvery deviation arrives with the batch, the stage and the SOP revision already attached.Production · QA · Investigators
Deviation recordsRecord a deviation with a required title, its type (including Planned), category or risk level, structured cause, source (for example Human Error) and controlled reason codes.You get: Deviations classified the same way every time, ready to trend.
Link to Change ControlLink an existing change or choose New Change Control; the change number, description, requester, category and department show on the deviation.You get: Deviations that need a permanent fix lead straight into governed change.
Operational contextEach deviation carries the ERP reference transaction, affected product and batch, processing stage (for example Raw Material), SOP number and SOP revision, and start and end dates.You get: Investigators start with the facts instead of rebuilding them from three systems.
Approval lifecycleApprove, return with Needs Update, reopen and close. An approval-maintenance view lets authorized users remove an approval made in error.You get: Clear dispositions, and a controlled way to correct them.
Queues, search and list contextAll, Favorites, Submitted, Approved and Rejected views, status filter and keyword search; lists show status, type, category, cause and transaction without opening the record.You get: Faster triage across the whole deviation population.
Investigation and root causeRecord the investigation, root cause, impact assessment and conclusion on the deviation.You get: A complete case from event to conclusion.
Multiple products and batchesLink one deviation to several products and batches.You get: Real events recorded at their real scope.
Deviation tasksRaise deviation tasks in the shared task list.You get: Follow-up work is owned and dated.
Material review and dispositionDecide use as is, rework, repair, regrade, return to vendor or scrap for each affected quantity, and post it to the connected ERP.You get: Dispositions that are approved, complete and already in inventory.
Formal deviation outputsPreview, print and email the deviation report.You get: Records ready for batch documentation and audits.
Batch hold and dispositionHold affected ERP batches while a deviation is open and record the disposition at release.You get: No batch leaves while its deviation is unresolved.
Planned-deviation validityGive planned deviations an approved window and flag use outside it.You get: Planned deviations stay within what was approved.
One module, every kind of eventDeviations, nonconformances, OOS and OOT results, excursions and CCP breaches each get the fields and lifecycle they need.You get: Industries use their own vocabulary without a second system.
Out-of-specification investigationsRun phase I and phase II OOS and OOT investigations on the quality order, test and sample, with controlled retests.You get: Laboratory results investigated the way inspectors expect.
Who received it?Trace a deviation's batches to the customers who received them and the suppliers behind them, and record the impact on each.You get: Impact assessed in hours, with the trace on file.
Excursions captured automaticallyOut-of-control SPC points, MES alarms and temperature-logger excursions open an event with its reaction plan.You get: Containment starts when the signal does.
Batch review by exceptionExceptions from electronic batch records and MES arrive as events on the batch, so reviewers see only what needs a decision.You get: Faster batch release without skipping a check.
Classified, with deadlinesEach event is classified by your rules and gets a closure target by class; extensions need approval.You get: Fewer late investigations and consistent classification.
Customer concessionsAsk a customer to accept nonconforming product and keep the approval, limits and expiry on the record.You get: Nothing nonconforming ships without the customer's yes.
FOD and special-process eventsRecord foreign object debris and special-process escapes against the part, operation and supplier certification.You get: Aerospace escapes handled the way customers expect.
Business benefitFrom the first call to the recovered claim, one complaint record.Customer service · Quality · Regulatory · Supplier quality
Complaint intakeRecord a complaint with title and description, an ID numbered by category, the External, Internal or Other category, owner, severity and priority; mark favorites.You get: Every complaint is owned and classified from the first minute.
Products and contextLink affected products, map complaint types to ERP transaction types, and add keywords, notes and related SOPs.You get: Product-level trending and the procedural context on one record.
Vendor, transport and third-party claimsRecord the vendor or carrier, notification dates, and each claim's flag, number, date, comments and response, including claims against other external parties.You get: Costs caused by others are claimed, not absorbed.
Nine-status lifecycleRegister, request more information, accept, reject, close and reopen. Workspace tiles show how many complaints sit in each of nine statuses.You get: Managers see the shape of the workload at a glance.
Investigation detailsA dedicated, numbered investigation area separate from intake.You get: Investigation and intake each stay readable.
CAPA and tasks from the complaintCreate a new CAPA from the complaint's resolution and see its number, status and date there. Add tasks with owner, status and due date.You get: Systemic issues reach corrective action, and follow-up gets done.
Policies and regulationsMaintain policies and laws or regulations as approved reference data, then reference them, with notes, on complaints.You get: Handlers know which obligations apply, from a controlled list.
Deadlines and alertsSet a target resolution date, an alert a chosen number of days ahead or on a custom date, and extra recipients by email.You get: Deadlines are met because people are told in time.
AdministrationSwitch complaint workflow on or off, set the report logo and number sequences for complaints, investigations, policies, regulations and tasks.You get: The process fits your organization without custom code.
Reportability assessmentRecord whether a complaint must be reported to a regulator, the basis and the due date.You get: Reporting obligations are decided and evidenced on every complaint.
Claim value and recoveryRecord claimed and recovered amounts on every claim.You get: Finance sees what quality recovered.
Customer correspondenceSend templated acknowledgment and closure letters and keep a log.You get: Consistent, provable customer communication.
Rejection with reasonsReject with a controlled reason code and description.You get: Every rejection is explainable to the customer and the regulator.
Reports, history and workspacePreview and email complaint reports, see who previewed last, review the full status history, and work from ten views plus an Analytics tab.You get: A complete, retrievable record of how each complaint was handled.
Return and credit linkLink complaints to the connected ERP return orders and credit notes.You get: Customer remedies and quality cases in one place.
Complaint trendingComplaint rates by product, batch, customer and vendor against volume shipped, with threshold alerts.You get: Rising rates are seen before they become recalls.
Intake from service channelsCreate complaints from Customer Service cases or a web form.You get: No re-keying between service and quality.
Regulatory reports on the clockEach reportable complaint follows the workflow and deadline of its regime, with the submission reference kept on the record.You get: Reports made on time, and proof that they were.
Return failure analysisTake returned parts through failure analysis, keep the results with the complaint and link them to the 8D.You get: Returns explained with evidence.
Warranty and service linkSee warranty claims and service work orders on the complaint, with their cost.You get: Field cost and field signals in the quality record.
Counterfeit and suspect partsReport, quarantine and trace suspect or counterfeit parts, and block their source.You get: Counterfeits stopped before they reach a product.
Returns grading and recoveryGrade every return, decide its disposition and charge the supplier back, with inventory updated in your system.You get: Returns margin protected and supplier cost recovered.
Recalls and mock recallsRun recalls and market withdrawals from the affected lots to every customer notice and return, and time your mock recalls.You get: Recall readiness you can demonstrate.
Standard complaint codingCode complaints by problem, component, cause and harm, including IMDRF terms for devices.You get: Complaints that trend and report cleanly.
Customer-specific rulesEach customer's response times, report formats and contacts apply automatically to its complaints and notices.You get: Customer requirements met without a spreadsheet.
Returns and reviews as quality signalsReturn reasons, reviews and marketplace claims arrive as complaint signals with the order, product and supplier attached.You get: Product problems caught at the first return, not the hundredth.
Business benefitOne list of quality work, every task tied to the record that needs it.Every team
Source-aware tasksEvery task carries its number, description, owner, status, due date and creation time, plus its source process, source document number and source title.You get: Assignees see what the task is for without opening another record.
Status views and filtersNot Started, In Process and Completed views, with filters by status, by source and on any column.You get: Slippage shows up early, and completed work is evidence.
Tasks for every processRaise tasks from Change Control, deviations and risks as well.You get: One task list for all quality work.
One consolidated listAn All Tasks view across quality processes, with dedicated views for CAPA tasks and complaint tasks.You get: One place to see and manage quality work.
Reminders and escalationRemind owners before due dates and escalate overdue tasks.You get: Fewer overdue actions.
Completion evidenceRequire a comment or attachment to complete a task where needed.You get: Completed tasks prove what was done.
Delegation with historyReassign or delegate with a recorded reason.You get: Accountability survives absences.
Task templates and checklistsStart a recall, a containment or a change implementation from a template of owned, dated tasks.You get: Repeatable work done the same way every time.
Tasks on any record, in any systemCreate a task on any iQM record or on a batch, sales order or purchase order in your ERP; the task shows where it came from.You get: Quality work tied to the transaction that needs it, wherever it lives.
My tasksA personal queue for each user.You get: Everyone starts the day with their own list.
Teams and mobileUpdate and complete tasks from Microsoft Teams or a mobile browser.You get: Shop-floor owners close tasks where they work.
Dependencies and service levelsTasks wait for the step before them and show how long they have left.You get: Hand-offs that do not stall.
Business benefitRisks that turn into governed change, not entries in a register.Risk owners · Quality engineers · Supply chain
Risk registerRecord a risk with title, statement, impact, likelihood, a required category, mitigation strategy, department, owner and date identified.You get: Every risk has a statement, a rating, a treatment and an owner.
Risk to Change ControlCapture a related change with its category, requester, department and description. Administrators can copy the risk owner and department into the change and set its default category.You get: Mitigation that needs a change goes straight into governed change.
Controlled scalesMaintain categories, likelihoods, effectiveness values and mitigation strategies with description, display order and active state; changes are attributed.You get: One rating vocabulary, maintained without breaking history.
Risk and workflow statusRisk status (for example Open) and workflow status (for example Draft) are tracked separately, with risk start and end dates.You get: Whether a risk is live and whether it is approved are both clear.
Assessment defaultsSet default impact, likelihood, mitigation strategy and category for new risks.You get: Consistent starting points across assessors.
Numbering and oversightConfigure sequences for risks and related records, and see every risk in one view with its ratings, owner and both statuses.You get: Leadership sees the whole risk population in one place.
Risk score and heatmapCompute a priority from impact and likelihood with a configured matrix and show it on a heatmap.You get: Risks ranked, not just listed.
Risks on real objectsLink risks to items, resources, sites and vendors in the connected ERP.You get: Risk tied to the thing it is about.
FMEA and hazard analysisSeverity, occurrence and detection analysis for process and product risks, with AIAG-VDA Action Priority.You get: Structured analysis where regulators expect it.
Risk signalsEvery complaint, deviation, CAPA result, sample failure, overdue mitigation and change that touches a risk is logged on it, with a link back.You get: Ratings explained by evidence, not memory.
Deviations that update process riskLink a deviation to the process risk for its stage; its classification is proposed from that risk, and recurrence updates the rating.You get: Consistent classification and process risk that reflects what happens.
Risk assessed on every changeEach change carries a risk assessment sized to its class, with risk before and after.You get: Approvers see what a change does to risk before they sign.
Residual risk and controlsRecord controls, their effectiveness and the residual rating.You get: Proof that mitigation reduced the risk.
Periodic reviewSet review cadence, reviewer and outcome for each risk.You get: The register stays current.
Risk from quality trendsPropose a risk when deviation or complaint trends cross a threshold.You get: Reactive signals feed proactive risk.
Complaints that update riskLink a complaint to the risk it proves; the risk's occurrence and severity evidence update.You get: Field experience reaches the risk file the day it arrives.
CAPA results that re-rate riskWhen a linked CAPA is verified, its control and effectiveness update the residual risk; if it did not work, the risk reopens.You get: Proof that corrective action reduced the risk.
Sample results that inform riskFailed, retested and scrapped samples update the material and supplier risks they relate to.You get: Supplier and material risk measured, not guessed.
Risk-based triageNew events start with severity and priority from the risk they touch, and high-risk events route to more reviewers.You get: Effort goes where the risk is.
Living risk fileWhen signals cross a threshold the owner is asked to re-assess, and every assessment is kept as a version with what changed and why.You get: A risk file that stays current and shows its history.
Medical-device hazard analysisHazard, hazardous situation and harm, with control measures, verification and overall residual risk, structured as ISO 14971 describes.You get: A device risk file linked to the products and events it covers.
Risks linked to control plansEach control on a risk points to the test, sampling plan or control-plan line that detects it.You get: Process risk and inspection stay aligned.
Supply-continuity riskRecord single-source, lead-time and concentration risks on the items and suppliers they affect.You get: Shortage risk seen before it stops supply.
Supplier risk from Supplier IntelligenceSupplier scores, audits and exposure from Zeak Supplier Intelligence update supplier risk, and quality events flow back.You get: One supplier risk picture across quality and procurement.
Risk-based samplingA supplier's or material's risk sets how much incoming inspection it gets: tightened, normal, reduced or skip-lot.You get: Inspect more where it matters and less where it is proven.
Risk acceptance rulesYour criteria decide which risks are acceptable; accepting one above the line needs a recorded rationale and an authorized signer.You get: Consistent, defensible risk decisions.
Food-safety hazard analysis (HACCP)Hazards, critical control points, limits and monitoring, with limit breaches raised as events.You get: Food-safety plans tied to the batches and lines they protect.
Risk portfolioSee risk by product, site, process and supplier, with trends and open mitigations.You get: Leadership sees exposure, not just entries.
Mitigation plans that finishMitigation actions are owned, dated tasks, and a risk only closes when they are done and the control is verified.You get: Mitigation done and proven, not promised.
Risk-informed audit plansAudit frequency and scope follow the risk of the process or supplier.You get: Audit time spent where the risk is.
Allergen controlAllergen profiles, cross-contact risk and cleaning verification by line, with allergen complaints escalated at once.You get: Allergen risk managed line by line.
Emerging-risk suggestionsPatterns across complaints, deviations and CAPAs are suggested as possible new risks for review.You get: Patterns surface before they become findings.
Business benefitOne sample framework from the receiving dock to the customer's lab.QC labs · Receiving · Production · Sales
Sample intakeCreate a sample with its reference context, a required quantity, a configured type, an assignee and, where relevant, a destructive date.You get: Every physical sample is numbered, owned and accounted for.
Production and purchase contextSelect a production order (status, quantity, type) or purchase order (approval and order status, type, vendor), with source line, item and product.You get: Samples trace to the order and line they represent.
Quality order and test contextSelect the quality order and see its status, quantity, reference, test and test sequence on the sample.You get: Testers know exactly which test step each sample serves.
Vendor and customer samplesRequest a vendor sample or ship a customer sample directly from the sample list.You get: Supplier and customer sampling run in the same framework.
Personal and lifecycle queuesAll Samples, My Assigned, My Pending Approvals and Unassigned, plus New, Approved, Testing in Progress, In Review, On Hold, Rejected, Retest Required and Scrapped.You get: Nothing waits on a shelf without an owner.
Disposition and historyScrap samples, open their history, read test sample logs, and triage from lists that show the key fields.You get: Sample handling that can be reconstructed.
Sample orders with sample itemsTrigger a sample order to a customer or from a vendor from the sample framework, with one or more sample items, quantities and units, and the batch where it matters.You get: Every sample sent or requested is an order you can track.
Sample shippingCapture ship-to, carrier and shipping method on the sample order, so samples move with a shipment record.You get: Samples shipped and traceable like any order.
Retained samplesTrack retention period, storage location and destruction due date.You get: Retention that meets GMP expectations.
Chain of custodyRecord every transfer between people and locations.You get: Custody that holds up in an investigation.
Source viewsSales order, quality order, inventory, production order and purchase order sample views.You get: Receiving, production and sales each see their own samples.
Native test setupSampling setup links to the connected ERP quality orders, item sampling and sample types.You get: Test rules are defined once, in the connected ERP.
With or without costIssue a sample order with an associated cost or as a no-charge sample, with the choice recorded on the order.You get: Sample cost decided and recorded, not assumed.
Results on the sampleShow quality-order test results on the sample record.You get: Sample and result in one view.
Labels and barcodesPrint labels and scan to find or update samples.You get: Fewer handling errors.
Turnaround measuresTime from New to Approved by source and type.You get: Lab and receiving performance made visible.
Environmental monitoringPlan and track environmental samples by location and schedule, trend the results and raise excursions as events.You get: A contamination-control program in the same system as your batches.
Sample cost visibilitySee what samples cost by customer, vendor and item, charged or free.You get: The cost of sampling, finally visible.
Stability sample pullsPlan and track stability pulls by condition and time point, with results from your LIMS and trends flagged.You get: Stability programs that run on time.
LIMS integrationExchange samples and results with your LIMS.You get: Integrate where a LIMS is the system of record.
Supplier certificates of analysisCheck supplier CoA values on the incoming sample and earn reduced testing from a proven record.You get: Less incoming testing, with evidence.
Customer certificates of analysisProduce a CoA for each shipment against the customer's own specification, and stop the shipment if a result is outside it.You get: The right certificate with every lot.
Chain of identityTrack patient-specific material from collection to administration with identity checks at every hand-off.You get: Whose material it is, proven at every step.
Business benefitConnected to your systems, audited on every transaction, ready for inspection.IT · QA · Administrators
Audit trail on every transactionEvery create, update, approval, signature and system transaction in iQM is recorded with who, what, when, old and new values and why.You get: An audit trail inspectors can open on any record.
Validation acceleratorTraceability matrix, IQ/OQ/PQ templates, risk-based test scripts and vendor test evidence for each release, scoped to what you put live.You get: Lower validation effort, and a smaller scope to validate.
Attachments and evidenceVersioned evidence files on every quality record.You get: Evidence lives with the record.
E-signatures on every approvalSignatures with recorded meaning on change, deviation, complaint, risk and sample decisions.You get: Signed decisions across the whole quality system.
Security rolesDocumented ERP security roles per module, with no self-approval.You get: Access your IT and QA reviewers can verify.
Quality dashboardVolume, aging, cycle time and recurrence across all modules.You get: One view of quality performance.
Conditional routingRoute by severity, product or site, with delegation and escalation.You get: Approvals that adapt to the case.
Document and training integrationConnect to your document control and training systems.You get: Change, procedures and training stay in step.
Audit and inspection findings, everywhereAudit and inspection findings are recorded as the source of CAPAs, deviations, risks and changes, with references and due dates.You get: Findings handled in the same records as everything else.
Cost of poor quality, measuredScrap, rework, retest, returns and recovered claims are measured from your ledger by site, product and supplier.You get: A value case Finance can audit.
Part approval and first articlesTrack PPAP, first-article inspection and APQP status for each part and supplier.You get: No new or changed part ships without its approval.
Trace forward and backTrace any quality event to the customers who received the product and the suppliers behind it, and keep the result.You get: The fastest trace is the one your ERP already knows.
AI assistSuggested classification, similar past cases and likely causes on new events.You get: Faster, more consistent triage.
Supplier collaborationSuppliers respond to claims, sample requests and corrective actions through Zeak Supplier Intelligence.You get: Supplier follow-up without email chains.
Management review packThe management-review inputs assemble themselves from every module; decisions and actions are recorded.You get: Management review in hours, not days.
Industry starter packsStart from a configuration built for your industry: codes, event types, change classes, risk methods and reports.You get: A faster start that already speaks your industry's language.
Calibration out-of-tolerance impactA failed calibration opens an event that shows which products were measured since the last good check.You get: Measurement problems contained, not discovered at audit.
Data integrity by designControlled fields need a reason to change, approved records lock, and nothing controlled is ever deleted.You get: Records that hold up to a data-integrity review.
AI you can auditEvery AI suggestion shows why it was made and who accepted it; AI never approves or signs.You get: AI help without losing control of the record.
Capture on the shop floorRaise an event from a terminal or phone with a photo and a scanned batch or serial.You get: Problems recorded where and when they are found.
Annual product quality reviewEvery product's annual review assembles itself from the year's deviations, CAPAs, changes, complaints and results.You get: Annual reviews in days, not weeks.
Carrier and 3PL scorecardsScore carriers and logistics providers on damage, excursions and claims recovered.You get: Carrier performance you can negotiate with.
Connects to the systems you already runConnect iQM to your ERP, MES, LIMS, PLM, CRM and e-commerce systems, whichever vendors you use, and use any record or field they expose that you authorize.You get: Quality on your records, whatever system holds them.
Live links to records in your systemsAny quality record can point to a batch, order, item or supplier in your systems, with live status and a snapshot of what it showed at the time.You get: ERP context without copying ERP data.
Built for many sitesShare masters globally, configure locally, and see quality across sites and legal entities.You get: One quality system across the enterprise.
Open to your other systemsMES, LIMS, PLM and SPC systems can create and read quality records, and quality events notify the systems that need them.You get: Quality connected to the rest of the plant.
Device identifiers on every recordUDI device and production identifiers on complaints, events, CAPAs and recalls.You get: Device records that match how regulators search.
Product qualificationTrack qualification and reliability testing per part and site, and requalify when a change requires it.You get: Qualification evidence ready when customers ask.
Works standaloneRun iQM on its own, with its own items, lots, suppliers and customers, and connect systems later.You get: Start with quality now; integrate when ready.
Your cloud or oursRun iQM in the Zeak cloud or in your own cloud environment.You get: Your data stays where your policies require.
Controlled-data protectionClassify records and files, and keep export-controlled and confidential data away from people and systems not cleared for it.You get: Controlled technical data stays controlled.
Product approval before launchApprove private-label and new products, with supplier, test and label evidence, before they are listed.You get: Products you sell are products you have checked.
A workspace for every rolePeople doing the work see their tasks and records, quality and IT owners see controls and exceptions, and leaders see value and trends.You get: Everyone opens iQM to what they care about.
Your data, always exportableExport every record, file, audit entry and setting in open formats whenever you want.You get: No lock-in, by design.
The autonomy ladderChoose for each capability whether iQM observes, advises, assists or acts, and move between stages only when your criteria are met.You get: Change at the pace you approve, reversible at every step.
Reasons behind every flagEvery flag and suggestion shows the rule or model, the data and the source records behind it.You get: No black boxes.
Supplier certifications and approvalsTrack each supplier's certifications and approved processes, and stop purchases when one lapses.You get: Only approved suppliers, for approved work.
Quick startA simple setup with short forms and one-step approvals, running in days and ready to grow.You get: Quality running this week, with room to grow.
Value you can showSee value against the agreed baseline, traced to the records that created it.You get: A business case that keeps proving itself.
Read-only first, write-back by approvalConnect read-only first; switch on each write-back to your systems only when you approve it.You get: You decide what iQM may change in your systems.
Backtest on your own historySee what iQM would have flagged on your last six to twelve months of records, compared with what actually happened, before anything goes live.You get: Proof from your own data, not our claims.
Your pilot charter, in iQMYour success and failure criteria, baseline, risk register and stage-gate approvals kept in one place.You get: The plan is yours, in your words.
Each module has core features plus advanced and industry features. Availability by release is confirmed in your proposal and verified during the pilot.
A connected decision
From a customer complaint to a governed fix, with the supplier paying its share.
- 01RecordForeign material reported in a finished product, logged against the product and batch.
- 02UnderstandTraced to one supplier's lot; the claim is recorded on the complaint the same day.
- 03ActA CAPA is created from the complaint; containment tasks go to receiving and production.
- 04ChangeAn incoming-inspection change is routed to Quality and Procurement and implemented within budget.
- 05VerifyThe change is verified, the CAPA closed with e-signature, and every step is in the history.
Without the connected view
Procurement learns about the supplier issue weeks later, the claim window has closed, and the fix is a memo, not a change.
With it
One complaint carries the product, the supplier claim, the CAPA, the tasks and the change—and posts a signal to the supplier risk.
Configured to your products and transactions, not customized in code.
A deviation on a sterile product routes to QA and the production head, with a 5-day root cause and a signature at closure. On a non-sterile product it routes to the area supervisor with a 10-day target. One workflow, two configurations.
What your administrator configures—versioned and approved
The platform under every module
Standalone, connected or both. Your systems stay the system of record.
No need to customize your ERP or fund a costly custom build. Connect read-only first; switch on write-back object by object when you approve it.
Start standalone
iQM holds its own items, lots, suppliers and orders. A team can be running in days, with no integration project.
Connect to what you run
Live links to records in your ERP, MES, LIMS, PLM or CRM, with the context filled in on every quality record.
Mix across the enterprise
One quality picture across sites on D365, NetSuite, SAP or standalone—including acquired businesses.
Connects to
Microsoft Dynamics 365
SAP S/4HANA
Oracle
NetSuite
Microsoft Dynamics 365SAP S/4HANAOracleNetSuiteand any other ERP, MES, LIMS, PLM, CRM or custom system—including your custom fields and objects.
AI where it earns its place
Not every quality problem needs AI. Most need connected records and clear decisions.
AI is off until you switch it on. Where enabled, it suggests—showing its basis—and a named person decides. AI never approves, closes or signs a record.
- High volumes of free-text complaints, reviews and returnsSuggested classification and duplicate grouping, reviewed by a person
- Finding similar past casesRanked suggestions for the investigator, with the reasoning shown
- Weak patterns across many recordsEmerging-risk suggestions a risk owner accepts or rejects
The autonomy ladder · set by you, per site
- 1ObserveRead-only and in parallel. Your process runs exactly as today.
- 2AdviseSuggests values, flags risks and proposes links. People accept or reject.
- 3AssistPre-fills records and drafts actions. Nothing is committed without a person.
- 4ActAutomation for routine, well-proven cases only. Exceptions route to people.
Most quality value comes at Observe and Advise. Many customers never need Act—and that is fine.
Standards
Built to support the standards you're held to.
Supported through configuration; applicability depends on your industry and markets. Not a claim of certification: compliance is your organization's obligation, and Zeak produces the evidence.
- FDA 21 CFR Part 11
- EU GMP Annex 11
- ALCOA+
- FDA cGMP
- ICH Q9 and Q10
- ISO 9001
- ISO 13485 / QMSR
- ISO 14971
- IATF 16949
- AS9100
- AIAG-VDA FMEA
- FSMA
- ISO 22716
- SOX and J-SOX
- SOC 2 controls
- ISO 27001 controls
- GDPR
Industries
Built for every industry. Configured to the way yours works.
Regulated or not. Most real companies don't fit one box—that's normal. The same seven modules are configured to your products, risks and rules, with industry starter packs.
Pharma, Biotech and Medical Devices
Deviations and CAPA on the batch, SOP revision on the record, complaints to CAPA, chain of identity and signed decisions.
Chemicals and Process
Off-spec lots and claims, incoming sample failures, vendor claims and process-safety management of change.
Food and Beverage
Allergen and hold control, lot traceability, HACCP, recalls and mock recalls.
Cosmetics and CPG
Adverse events traced to ingredients; packaging and label changes governed and verified before launch.
Semiconductors and Electronics
Excursions traced to lots and wafers; customer and supplier change notices on the JEDEC clock.
Aerospace and Defense
Nonconformance, counterfeit and suspect parts, first articles and FOD and special-process events.
Automotive, Industrial and Discrete
8D, part approvals, field returns to root cause and FMEA linked to control plans.
Distribution, E-Commerce and General Manufacturing
Returns traced to suppliers, carrier and 3PL scorecards, and scrap and rework made visible.
Industry features are configured and phased to your scope. Regulated workflows require use-case-specific configuration and validation, confirmed with your quality team.
Security and DevOps
Trust is part of the product. Releases that never surprise production.
The controls that let a quality head, a regulator and an IT owner all say yes—and a governed release path for every update.
Security, records and governance
Your cloud or oursYour own cloud tenant or the Zeak cloud, under the identity and security your IT team operates.
SOC 2 and ISO 27001 controlsOperated under SOC 2 and ISO 27001 controls, with GDPR-aligned data handling.
Every transaction auditedEvery create, update, approval, signature and system event recorded with who, what, when, old and new values and why.
Signatures where they matterElectronic signatures with a recorded meaning on approvals and closures, where your procedures require them.
Approvals follow your organizationDepartment approvers, one stage or several, scaled by change class. No self-approval.
Your data, always exportableEvery record, file, audit entry and setting in open formats, at any time.
DevOps, validation and release management
Test before productionEvery versioned release tested in your test environment and promoted under your change control.
Validation acceleratorTraceability matrix, IQ/OQ/PQ templates, risk-based test scripts and vendor test evidence for each release.
Versioned connectorsTested against supported releases of your systems and maintained by Zeak—outside your ERP code.
One release pathProduct updates, configuration changes and your enhancements ship through the same governed path.
Regulated workflows, including electronic records and signatures, require use-case-specific configuration and validation. No blanket compliance claim is made.
Why teams switch to Zeak
Customize the ERP, or switch on iQM.
Building quality into your ERP is a project, then a product you maintain. A separate QMS avoids the build but adds a second place to look.
Time to first value01
Customize the ERPSix to nine months of build and validationZeak iQMWeeks: read-only alongside your process, on real records
Build cost02
Customize the ERPA build project: design, workflows, integrations, testing and validationZeak iQMNo workflow, form, integration or audit-trail code to write
Connected records03
Customize the ERPBuilt and maintained by your projectZeak iQMOrders, batches, suppliers and SOP revisions referenced live
Validation04
Customize the ERPEvery custom change re-validatedZeak iQMA validation accelerator: traceability, IQ/OQ/PQ templates, test evidence
ERP updates05
Customize the ERPYour custom code retested every service-update cycleZeak iQMiQM sits outside your ERP code; connectors are maintained by Zeak
Changing the process06
Customize the ERPA change request to ITZeak iQMConfigured by your administrator
Is iQM a fit?
A quick, honest check before you evaluate.
Signs iQM will help
- Investigators rebuild batch, order and supplier details before they can start
- Supplier-caused defects are found, but claims are rarely filed or recovered
- CAPAs close, but the change that removes the cause never happens
- The risk register is reviewed in meetings, not updated by what happens
- Sites run different ERPs, or quality lives in spreadsheets
- An inspection, audit or customer review is coming
Signs to wait, or start elsewhere
- You need a LIMS, document control or training system firstiQM connects to those systems; it does not replace them. Start there, then connect iQM.
- There is no one to own the processA pilot needs a named process owner and a few hours a week from the quality team.
- Your current process works and nobody feels the costIf there is no visible cost or risk to fix, wait until there is one worth measuring.
Recognize three or more signs? A one-hour walkthrough of your current process is usually enough to tell whether a pilot is worth it.
Start with a pilot · low risk by design
Prove one process. Then expand.
One site, one process family, one owner, one measure Quality and Finance agree. You can stop after any step and keep everything you have learned.
- 01ScopeOne process family at one site, with a named process owner and success and failure criteria.
- 02DefineQuality and Finance agree the baseline and measures before work begins.
- 03BuildMasters, approvers and connectors configured in your test environment—read-only first, your ERP untouched.
- 04ValidateReal records run alongside your process, with a backtest on your history and results reviewed against the baseline.
- 05Launch & expandMove up the autonomy ladder, and to the next process or site, only when your criteria are met.
What it takes from your team
- Process owner
- A few hours a week through the pilot
- Quality team
- A few hours a week for real records and feedback
- Finance contact
- Baseline agreement at the start; review at the readout
- IT and platform owner
- Read-only access, single sign-on, roles and a test environment
What we will not ask you to do
- Replace your ERP or the process your team built
- Move your master data
- Sign a long commitment before the pilot result
- Accept a business case built on headcount reduction
- Turn on AI, or move past Observe, before you are ready
Built by founders with 25+ years each delivering SAP, Oracle and Microsoft Dynamics programs in regulated industries, with prior work at Accenture and Oracle.
How to engage
Start with iQM. Shape it to how you work.
Yes—we personalize iQM to match your procedures, initiatives and organization. Choose the path that fits where you are.
01BASE SOLUTION
Start with iQM
The production-ready solution, configured to your products, transactions, departments, approvers and signatures.
HOW IT’S PRICED
Terms agreed in your proposal
Selected opportunities may be co-invested with Zeak.
02PERSONALIZE
Enhance it to your processes
Match iQM to your procedures and initiatives: your fields, workflows, methods, reports and integrations.
Typically tailored
HOW IT’S PRICED
Time and materials
Custom enhancements to an existing application require your T&M approval before work begins.
03NEW SOLUTION
Build something new
For a need beyond iQM, we evaluate the solution with you and agree the delivery model that fits.
HOW IT’S PRICED
Time and materials · Fixed cost · Hybrid: T&M + outcome-based
We explore every option with you.
How an enhancement worksShare the need → we scope and estimate it → you approve → we build it on the Zeak platform and release it through the governed path described in DevOps.
Start with one process
Bring us your quality problem.
One process family, one site, one measure Quality and Finance agree. Selected opportunities can be co-invested with Zeak. Scope, timing and pilot terms are agreed in your proposal.
Take the details with you
zeak1 PAGE
iQM QUALITY MANAGEMENT
Quality decisions belong where the work happens.
One-page brochure
The problems iQM solves, the standards it supports and how to start.
zeakCUSTOMER OVERVIEW
7 MODULES · 197 FEATURES
iQM Quality Management
Customer overview
All 197 features, the value method, the pilot approach and hard questions answered.
Before you decide
Hard questions. Plain answers.
Including the questions a careful buyer should ask us, with the limitations stated up front.
See all Zeak FAQsFit with your systems
No. iQM works alongside it. Where your ERP has quality orders, inspection or sampling, iQM uses them, and adds change control, CAPA, deviations, complaints, risk, samples and tasks on the same records.
Advanced Quality Management adds native CAPA, sampling plans and e-signatures in current D365 releases. iQM adds general change control with department routing and budget control, complaint handling with claims and regulations, connected risk and one task list. Where both apply, the boundary is agreed in discovery.
Yes. Zeak is platform and system independent. iQM runs standalone or connects to Dynamics 365, SAP, Oracle, NetSuite, Infor, Acumatica and other systems through connectors.
Compliance and control
No software makes you compliant on its own. Compliance comes from a validated system used under your procedures. iQM provides an audit trail on every transaction, e-signatures with a recorded meaning, data-integrity controls and a validation accelerator; validation scope is agreed per customer and remains your decision.
No. AI is off until you switch it on. Where enabled, it makes suggestions only: each shows its basis and is accepted or rejected by a named person. AI never approves, closes or signs a record.
In your own cloud tenant or the Zeak cloud. Records in your connected systems stay there; iQM keeps a live link and a snapshot of what they showed at the time of the event. You can export every record, file, audit entry and setting in open formats at any time, and receive a complete archive at contract end.
Working with Zeak
This page describes the full iQM capability set. Which features are available in which release is confirmed in your proposal and verified in the pilot before you rely on it.
The pilot is designed to run real records through iQM within weeks of configuration. It takes a process owner, a Finance contact, a few hours a week from the quality team, and IT for access. We say so up front because a pilot is never free to the people running it.
Yes. We personalize iQM to your business and organization. Custom enhancements to an existing application are delivered as time-and-materials services, approved by you before work begins. For a completely new solution, we evaluate it with you and can deliver it at time and materials, fixed cost, or a hybrid of time and materials and outcome-based pricing.
No. iQM orchestrates samples and references documents and training; where you run those systems, iQM connects to them rather than replacing them.