Quality Process Digitalisation & eQMS
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Paper quality processes slow teams down and leave data integrity exposed. BIO15PHARMA moves you to a validated electronic quality system, with data integrity designed in from the first step and an audit trail ready for any inspection.
Who it is for
Quality and IT teams at regulated manufacturers ready to move from paper to a validated electronic quality system.
What we deliver
- Electronic batch records (EBR)
- Electronic document management (EDMS) with compliant electronic signature
- Deviation and CAPA management
- Incident and non-conformity management
- eCRF for clinical trials and validated e-learning platforms
- Implementation, qualification and computer system validation (CSV)
Proof
Systems built for data integrity by default, following ALCOA+ principles, with electronic records and signatures aligned to 21 CFR Part 11 and EU GMP Annex 1.
Standards
ALCOA+ data integrity, 21 CFR Part 11, EU GMP Annex 1.
Contact us to digitise your quality processes.
| Product composition | <p>Move from paper to a validated eQMS: electronic batch records, EDMS, CAPA and computer system validation, built for data integrity from the first step.</p> |
|---|---|
| Private label | No |