PSC® provided the client with non-medical technical writing support including Data Science and Regulatory Affairs focused, a Pharmacovigilance process improvement initiative, and other Clinical Science process improvement efforts.
PSC® provided Validation and Compliance Technical Writing for the transition of computerized systems for the client. Responsibilities included but were not limited to generation, re-visioning and execution of the following SDLC validation documentation: Compliance Analysis, Compliance Plan, User Requirements, Functional Requirements, Test Protocol, Test Execution, Traceability Matix, and Compliance Report of the computerized systems.
This project is a remediation Validation and Compliance Project Management for the transition of computerized systems from the previous system.
PSC® executes approximately 40 CSV projects per annum across the full spectrum of systems (bench-top instruments through enterprise applications such as ERP, DCMS, and QMS.
PSC® has provided the client with cross-regional support in California, Ohio, and Canada. These projects have focused on the clients CRM and Vault modules(QMS, eTMF, Quality Docs, PromoMats, EDC).
Equipment Qualification, Computerized Systems Validation, IT, QA, Systems Assurance, EDMS, Administration Business Analysis
