Industries
Pharmaceutical manufacturing
QA, regulatory affairs, and plant operations teams at pharmaceutical manufacturers carry the same obligations as the largest enterprises — supplier qualification, deviation and CAPA tracking, stability studies, export documentation — usually with a fraction of the headcount and none of the software budget built for it.
What usually goes wrong
- Documentation spread across shared drives, spreadsheets, and email, with no single source of truth for an auditor to follow.
- Deviations logged after the fact from memory, and CAPAs closed by flipping a status with no real accountability step behind it.
- Export certificates and dossier requirements tracked by whoever remembers to check the expiry date.
How Plumely helps
- Deviation & CAPA Tracker — Mobile-first deviation logging and CAPA tracking built for the shop floor, not just the QA office.
- Supplier & CoA Qualification — Verify every incoming batch has an in-spec, non-expired CoA from a qualified supplier before it reaches your line.
- Export Documentation & Compliance — CoAs, CoPPs, WHO-GMP certificates, and shipping documents — tracked, versioned, and never expired without warning.
- Country Dossier Checklist — Living, country-specific dossier checklists for CTD, ACTD, and Module 1 requirements across emerging markets.
- Stability Study Tracker — Pull-point calendars, sample inventory, and overdue-test alerts for every active stability study.
Why Plumely instead of an enterprise QMS
Enterprise quality-management suites are built and priced for organizations that can afford a long implementation timeline and named-user licensing across every module, whether or not the team uses them all. Plumely is modular by design: activate the tools your team actually needs, assign them to the right roles, and skip the rest.
Compliance & security
Every organization’s data is isolated at the database layer, material actions are written to an append-only, hash-chained audit trail, and deviation closures carry a real electronic-signature step. Using Plumely supports common practices expected under GxP recordkeeping and 21 CFR Part 11 — compliance itself is a shared responsibility with your own validated procedures. Read more on our security & architecture page.