Sophos offers a robust and comprehensive Validation Package for implementation, upgrade, migration and maintenance of Safety Systems including Oracle® Argus Safety™ Application Suite and Aris Global™ ARISg which helps clients comply with 21 CFR Part 11 requirements. Our Validation Package ensures standards in which electronic files are considered equivalent to paper records, saving time, and effort.
Best pick is the fully validated Argus 8.x Validation Package.
Our validation experts work with client’s Quality department to meet custom needs, to comply the Validation Package with existing SOPs, execute and produce pieces of evidence to support audits and meet regulatory needs.
Our documentation templates includes:
- Validation Plan/Protocol
- User Requirements Specification
- Risk Assessment
- Functional and Design Specification
- IQ, OQ, PQ Scripts
- Requirement Traceability Matrix
- Validation Summary Report