Our approach
Quality requirements, agreed in the scope
We agree intended use, review steps and evidence with your quality team before building a regulated workflow.
Start with the intended use
Define the source, destination, users and records. Agree what the software can do automatically and where a person must review or approve the result.
Assess the relevant requirements
- EU GMP Annex 11: computerised systems in the applicable GMP context.
- 21 CFR Part 11: applicable electronic record and signature requirements.
- GAMP 5: risk-based guidance for the system lifecycle.
Agree the evidence and responsibilities
Scope the access controls, data checks, exception handling, testing and handover needed for the intended use. Your qualified experts approve controlled documents and make regulated decisions.
These references inform a project where applicable. They are not Mitigon certifications or a guarantee of compliance. Validation responsibilities and deliverables must be agreed for each project.