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Clients

It has been an amazing privilege for our teams to serve some of the greatest companies in the world along side the greatest colleagues anyone could hope for or expect. We are passionate about data integrity; business systems and processes; and software design, development, implementation and support. Nothing is more satisfying than to see a team working as one to help people become more productive and effective. Among our key clients are these listed here, below:

Regulatory Content and Development

Our teams can help to establish policies and procedures related to Computerized System Validation (CSV): Part 11 Compliance and Computerized Systems Policy, Electronic Signature and Record Policy, Security Policy, Computerized System Change Control, Validation of GxP Computerized Systems, Problem Reporting, Risk Assessments, as well as Periodic Reviews.

Regulatory Project Leadership

Our teams perform and lead Computer System Validation (CSV) projects related to authoring and executing specifications and validation documentation according to the GAMP5 Validation Life Cycle, including: Computer System Validation Plan, System Requirement Specification (SRS), High Level Risk Assessment (HLRA), Functional Requirement Specification (FRS), Design Specification (Software and Hardware), Commissioning, IQ, OQ, PQ, Summary reports, Requirements Traceability Matrix (RTM), Periodic Review of Computer Systems and Audit Trail review.

Life Sciences Data Governance Model Development

Our teams work closely with organizational leadership to establish guidelines, demonstrating global regulatory compliance with data integrity initiatives.

 
 
 

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