Document Control
ISO 13485 §4.2
Enforced revision history, approval workflows and effective dates. Only the current approved version circulates; every superseded one stays retrievable.
Why pharma
An inspector follows the chain, not the folder
A GMP inspection starts at a deviation and walks forward: what was the risk, what was the root cause, what did you change, and how do you know it worked. Every link in that chain is a record in InnoQualis, attributed, timestamped and append-only.
EU GMP Chapter 1 and ICH Q10
Deviations risk-assessed at logging, structured root cause, disposition, and a CAPA raised with the linkage kept.
Annex 11 and Part 11
Electronic signatures with meaning statements, soft-invalidation with a reason, and an audit trail nobody can edit.
EudraLex and EMA watched
The Officer polls EudraLex Volume 4, EMA, MHRA, PIC/S and the ICH Q-series, and maps each change onto your SOPs.
Training that holds
Chapter 2 training kept by document effectivity: when the SOP changes, the read-and-understand is assigned and signed.
Posture
Where we stand on the standards that matter here
| Standard | What it requires | Our status |
|---|---|---|
| 21 CFR Part 11 | Electronic records and electronic signatures | Self-attested |
| GDPR | Lawful processing, minimisation, right to erasure | Self-attested |
| ISO 9001 | General quality management framework | Controls in place, validation in progress |
| EU GMP | Good Manufacturing Practice for medicinal products | Controls in place, validation in progress |
Notes
- Statuses are stated as they are. Self-attested means our own attestation, not a third-party certificate.
What you get
The five modules, as sold today
Training Management
ISO 13485 §6.2
Role-based matrices, assignment straight from a controlled document, quizzes, and requalification tracked per person.
Deviation Management
EU GMP Ch. 1
Logged, risk-assessed, investigated and dispositioned, with a controlled path into CAPA when the investigation warrants one.
CAPA
ISO 13485 §8.5
Owned action items, due dates, and an effectiveness review that must complete before closure.
Internal Audits
ISO 13485 §8.2.4
Programme planning, checklists, findings and closure evidence. Findings raise CAPAs directly; external auditors get scoped access.