Computer System Validation (CSV)

A proven pragmatic approach to CSV that saves time and money without compromising business control

SeerPharma has been successfully supporting our Life Science clients for over 15 years in this complex compliance environment. Our validation and CSV team fully understand all international compliance standards, the benefi ts of leveraging risk analysis in validation and ensuring GxP critical systems are validated right fi rst time. We have a proven track record of bringing client projects in on time and within budget.

We adopt a pragmatic approach to validation and project management using risk assessments and the GAMP framework that saves excessive documentation without compromising business control.

International Resources: We can resource and co-ordinate multi-site, software rollout & validation programs, locally and internationally and act as client oversight or compliance project managers.

• Risk based validation strategies and services including GAMP and ASTM E2500
• Value added validation life-cycle document development
• 21 CFR Part 11 (Electronic Records and Electronic Signatures) compliance
• Validation of CTMS, DMS, MES, MRP, LIMS, and other enterprise GxP software
• Validation oversight services – client QA representative
• IT governance procedure development
• Gap assessments and software vendor audits

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