Validation Services | Perint Systems
Perint's Validation Consulting services enables us to support clients to meet all preparation and completion of system development life cycle (SDLC) documents. SDLC documentation packages may include User/Functional Requirement Specifications, Technical Design Specifications, Validation and Implementation Plan, IQ/OQ/PQ Protocols and reports, and Requirements Traceability documents. All SDLC documents are written in collaboration with the designated client department personnel.
In addition, we can assist in the preparation of documentation that supports the ongoing validation of the system: such as SOPs for computer system change control (hardware/software), system administration (administrative tasks and data management), and related training materials.
Our validation consultants have extensive experience in the Pharma, Medical Device and Biotech industries and can help customers meet regulatory requirements. Our approach for validation is based on Current Good Manufacturing Practices (cGMP) and the latest developments in 21 CFR Part 11 (such as the recent risk-based approach presented by the FDA).