as a SERVICE
Hawkins Point helps companies achieve quality systems compliance by leading Quality inititives. We plan and execute successful implementations of computerized systems within a GxP environment.
Quality Systems Compliance
We interpret regulatory guidance (GxP) and client policies and procedures into executable and defendable lifecycle documentation. We provide quality assurance oversight for system related issues, and guidance to project teams on the compliance requirements. We follow risk-based methodologies as it relates to CSV and general Quality practices.
Authoring, Review, and Approval of SDLC Documents
We support the development of all life cycle deliverables in compliance with the governing regulations and procedures (i.e., URS, FS, DS, Risk Assessment, TM, etc.). We perform supporting quality related activities associated with computerized systems including periodic reviews, procedures, defects, test scripts (IQs, UATs, System Tests, PQs etc.) Change Management, and test runs.
Leading Quality Efforts
We provide input and guidance on level of procedural rigor, Quality documentation workflow, compliance standards, and adherence with FDA, ISO, GAMP and other applicable regulations and industry guidance. We embrace your culture and integrate as part of your team to ensure practices are consistent and comply with organizational standards. We maintain all required trainings to maintain 100% compliance with procedures, job aids and work instructions.