We are Expert Computer System Validation (GxP|GAMP5) engineering consultants. We frequently execute validation (GxP|GAMP5) projects on a fixed price basis or offer our experienced Validation (GxP|GAMP5) Consultants or Validation (GxP|GAMP5) Engineers at an hourly rate basis that work out of our office or on your site.
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We offer validation services in equipment/computer-system, process validation and including test method validation. We realized that the quality of equipment or process is of utmost importance not only to the governing regulatory bodies but also to the overall success of the organization. Through our internal validation guidance documents and your SOPs we qualify your part/item by confirming that it; functions as designed/intended, can perform to desired/selected parameters, has minimal impact to the environment and does not pose any risk to the user. Our approach to every single validation is as follows:
Master Validation Plan
- FAT – Factory Acceptance Test
- SAT – Site Acceptance Test
- Initial Screening
- Validation Plan
- PSP – Part Specification Program Qualification Plan
- URS – User Requirement Specification
- FS – Functional Specification
Traceability Matrix
- Validation Protocol
- Validation Report
- Computer System Hazard & Risk Management
- BFU – Build Factory Utility
- EH&S Safety Report
- 3rd Party Electrical Verification Report
- MSA – Measurement System Analysis Report
- Correlation/Equivalence Study Report
Configuration Specification
- Software Configuration
Test
- Training
- IQ – Installation Qualification
- OQ – Operational Qualification
- PQ – Performance | Process Qualification
Review
- Document Submission/Filing
- Change Control
