Each team builds the processes it runs today, and links them together. The same signatures, audit trail and access control apply to every one, whichever standard you answer to.
Deviations, nonconformances, CAPA and change control next to the documents and training they affect, so each decision sits beside its evidence.
More about qualitySamples received against requests, results with checked calculations, and release only after review and signature.
More about labEquipment calibration and maintenance, approved suppliers and inspections, with what is due next on a calendar everyone can see.
More about operationsLots with expiry dates and storage locations, Quality's signed release before use, and a record of every receipt and use.
More about inventoryPart 11 is the FDA's language; ISO and food safety schemes ask for the same things in their own words: controlled documents, records you can trust, and who approved what.
Biotech, pharma, cell and gene therapy, biorepositories and CDMOs: deviations, CAPA, batch records, specimens and samples, equipment and training, with Part 11 signatures and a validation package with every release. More for life sciences
Design history, risk files, complaints, device history records and supplier controls, with document and record control that answers ISO 13485 §4.2.4 and §4.2.5, now part of the FDA's QMSR. More for medical devices
Requests, samples, methods, results and reports; equipment and calibration; technical records with changes tracked to the person and time, as §7.5 and §8.4 ask. More for testing labs
Monitoring logs and verification sign-offs as checklists on a page, corrective actions, supplier approval and audit preparation, with records signed and dated when they're made. More for food and beverage
Document control, nonconformance, CAPA and 8D reports, internal audits and supplier quality: documented information controlled the way ISO 9001 §7.5 expects. More for manufacturing
First-article inspection, traceability, special processes and configuration changes, with access limited to exactly who needs it and every change recorded. More for aerospace and defense
Batch records, SOPs and testing, kept with the signatures and history state inspectors expect.
