as a SERVICE
Hawkins Point helps companies achieve quality and compliance by leading providing these services in an MSP model. We plan and execute successful implementations of computerized systems within a GxP environment.
We support the development of all computer systems validation life cycle deliverables in compliance with the governing regulations and government regulations and industry best practices (GAMP5, PIC/S, ICH). We perform quality activities associated with Business Process definition, User Requirements, Validation Planning, Specifications, Tesing (IQ, OQ, UAT, Regressions, etc..), Traceability, Reporting, Change Management, and Periodic review.
Quality Management System (QMS)
WWe implement turnkey Quality Management Systems (QMS) that includes Quality Manual and CSV policy, validation deliverables, program governance and project management framework. It also ensures qualification of infrastructure laboratory, manufacturing, and enterprise infrastructure. The implementation of the QMS is strengthened by our extensive knowledge base of assets and accelerators.