All organisations involved in the manufacture of materials for the health care industry must demonstrate compliance with current regulatory agency requirements. Our validation consultants work with the client to address regulatory issues and comply with regulatory agency standards from project conception to final commissioning and handover.
Stopford Projects’ team of experienced staff are available to provide a service to the client in covering the full range of validation services:
- Preparation of Protocols - DQ, IQ, OQ, PQ
- Factory Acceptance Test & Site Acceptance Test protocols
- Validation master planning
- cGMP and gap analysis reporting
- Vendor audits
- Procedure writing
- Process Validation
- Prospective, Retrospective and routine validation services
- Development and Preparation of User Requirement Specifications
- Training for Validation
- Computer control and software GAMP validation
- Commissioning
- Cleaning Validation
Stopford are uniquely placed to assemble bespoke teams to match the needs of the client and more importantly to provide senior staff throughout the project lifespan ensuring project objectives and resulting design philosophy are clearly identified and met.
Stopford are experienced in fully integrating with client resources and specialist equipment suppliers in order to develop effective and creative solutions to particular client problems.
Stopford’s capability obviously rests squarely with the consultants and engineering staff they employ. These skilled individuals have a detailed knowledge of the current regulatory requirements for the industry allowing them to interpret specific problems and implement suitable solutions, leading to cost efficiency whilst maintaining the highest level of quality to meet the client’s requirements.