For organizations that must show a regulator how something was recorded, who did it and under what control.
Batch record with an audit trail aligned to 21 CFR Part 11 and EU GMP Annex 11, for pharmaceutical manufacturing.
View the eBR →Integration of electronic invoicing with management systems, with traceability for every document issued.
View software →Handling of personal data with access control, logging and compliance with the applicable regulation.
View data handling →For pharmaceutical manufacturing, the eBR detail, the mapping to Part 11 and Annex 11 and the supplier qualification dossier are at pharma.valdrent.com.
Tell us the process and the applicable framework. We tell you what evidence you need and the scope.
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