Regulated software
LIMS and drug-safety systems built for audits from day one, with validation packs to match.
Validation pack delivered with the codeFull details: Regulated software Read: Part 11 checklist for LIMS- A pharma, QC or diagnostic lab is moving off paper and spreadsheets.
- Your system has to pass audits and regulatory inspections.
- An existing system needs to be brought into a validated state.
- Audit trails & e-signatures
- Role-based access & locking
- Validation pack, URS → VSR
- GAMP 5
- CSV
- 21 CFR Part 11
- NABL
- EU Annex 11
- ALCOA+