We support our customers with tailored consultancy packages to help guide them through GMP compliance and the complexities of validation and qualification of their facilities and equipment. Supporting customers at each stage of a project, from initial URS preparation through all the qualification steps and into PQ. We provide support with critical validation documentation preparation, implementation and execution.
- User Requirement Specifications (URS)
- Validation Master Plans (VMP)
- Tender Proposal Evaluations
- Enhanced Design Reviews – Design Qualification (DQ)
- Factory Acceptance Tests (FAT)
- Site Acceptance Tests (SAT)
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ)
- Validation Summary Reports (VSR)
Our gap analysis studies and audit investigations address existing systems, equipment and validation documentation. They allow customers to understand where any shortfalls may exist in their systems or procedures.
Our consultancy service can also offer bespoke training packages on specific aspects including basic contamination control, cleanroom design & construction, current & proposed cleanroom standards, cleanroom changing procedures and engineering support for clean areas