Chronicle’s GMP Validation pack provides evidence that…
- Software development complies with GAMP 5 principles and Good Supplier Practice.
- Chronicle enables compliance with FDA 21 CFR Part 11 regulation and EU Annex 11.
- eBMR complies with FDA 211.188 and EU 4.20.
- GE QMS meets GMP requirements (Validation Support File includes reference audit Q&A)
- GE assessments have been independently audited by a GMP specialist.
Please contact your nearest GE representative for further details and to request access to the GMP validation pack.