How are quality events recorded and closed with evidence?
Record quality events where they happen, and close them out with evidence.
Deviations, corrective actions, audits and release review next to the batch they concern — and people make every quality decision.
Workflow 5 of 6 · Quality, Lab & Compliance
How it runs
Quality in V5 sits next to manufacturing rather than in a separate system. Deviations, corrective actions and quality review connect to the lot; the laboratory manages samples, methods, tests, SPC and stability; controlled documents, audit history and electronic signatures record what happened; and product safety data sheets are authored, reviewed and issued with recorded decisions.
Step 1 of 5
Test
Organise sample plans, requests, queues and results in the lab; use method-specific SPC views and stability studies; lab outputs feed certificates of analysis.
What changes
Quality Linked to the Lot
Investigations and decisions reference the batches, materials and people involved.
Evidence for Audits
Audit history, controlled documents and validation evidence support inspection readiness; they do not by themselves establish certification or your validated state.
SDS under Control
SDS move through recorded draft, approval and issue, and formulas show each product's SDS state.
Detailed pages in Quality, Lab & Compliance (29)
- Quality managementDeviations, CAPA and quality review.
- Audits & CAPAFindings linked to corrective action.
- Structured deviationsConsistent deviation records.
- QC releaseRelease decisions on the lot.
- Lab & QCSamples, methods, SPC and stability.
- Lab workbench & worklistsSample claims, plates, sensory panels and the sample dossier.
- Customer complaintsLinked to the lot; signed reportability and closure.
- Change controlImpact assessment, approval and effectiveness check.
- Risk register & FMEACalculated RPN, mitigation and review.
- OOS investigationsPhase I and II with signed advancement.
- Lab SPC & trendingWestgard rules on every result.
- Stability studiesPull schedules sent to the sampler.
- LIMS overviewLaboratory information management.
- Safety data sheetsAuthor, review and issue product SDS.
- REACH & CLPSupplier SDS changes and your own SDS.
- Documents & trainingControlled documents and training.
- Periodic document reviewScheduled document reviews.
- 21 CFR Part 11Audit trail and e-signatures.
- CalibrationInstrument schedules and certificates.
- Skills matrixWho is trained on each task and revision.
- Equipment registerEquipment identity, recorded service dates and linked history.
- Spare-part requestsKnown or unknown part requests followed through human triage, ordering and receipt.
- Cleaning & sanitationRecurring cleaning tasks with notes and photographs for procedural review.
- Supplier qualityApproval next to what arrives.
- Management reviewCommercial and quality data for review.
- Mobile auditsChecklists and findings on the floor.
- Audit readinessKeeping records inspection-ready.
- Compliance self-assessmentEvidence self-check, not a score.
- Food safetyControl-point checks and follow-up.
Related pages in other workflows
- Supplier qualificationApproved suppliers and documents.
- eBMR / eDHRThe batch record quality reviews.
- Traceability & recallGenealogy for investigations.
- FormulationComposition behind SDS disclosure.
Current limits
- Customer procedures and role permissions determine the required approval workflow.
- Software features do not by themselves establish certification or a customer's validated state.
- Approved methods, sample data and laboratory configuration are required; statistical and stability decisions need qualified review.
- Saving an SDS draft does not approve it. Qualified authors and reviewers must supply and assess the hazard determination; V5 does not replace professional classification or guarantee regulatory compliance.
Questions
- Does V5 decide the hazard classification for an SDS?
- Qualified authors and reviewers supply and assess the finished-product hazard determination; V5 records it with its supporting evidence and does not replace professional classification. Approval and issue are separate, recorded steps.
- Does V5 screen formulas against restricted-substance lists?
- Restrictions depend on jurisdiction, use and concentration, so requirements differ between customers. Contact us to confirm support for your required substance lists, limits and jurisdictions.
- Is V5 validated or certified?
- V5 provides audit history, electronic signatures, controlled documents and validation evidence. Those features support your validation; they don't by themselves make your system validated or certified.
Free Working Guides
Practical checklists for this workflow, downloaded in your browser.
UltimateFree guide
Deviation & CAPA Worksheet
Record a deviation with its facts, contain it, investigate with evidence, and turn the cause into actions with owners and an effectiveness check.
Free guide · 3 pagesUltimateFree guide
Quality Release Decision Checklist
Check what must be complete before a lot is reviewed, list every open item, and record the release or hold decision with its reason.
Free guide · 3 pagesUltimateFree guide
Audit Evidence Readiness Checklist
Ask yourself the questions auditors commonly ask, find the records that answer them, and turn every gap into an action with an owner.
Free guide · 3 pages