A Standard Approach and Documentation Set to Reduce Project Execution Time Lines, Validation Efforts, and Rework Cost. Use our Validation Services to Prepare and Execute Documents for: User Requirements Risk Assessment Installation, Operation, and Performance Qualification (I/Q, O/Q, P/Q) Functional Requirements (FS) Site Acceptance Testing (SAT) Validation Master Plans

Our Quality Assurance Services include:

• 21 CFR Part II Compliance
• Generation of Standard Operating Procedures
• Change Control Systems
• Deviation, Investigation, CAPA Programs
• Cold Chain Supply Validations