Fulfilling Marketplace Needs
As the pharmaceutical industry validation requirements have evolved over the years so has our approach to validation; we pay attention to regulatory changes. As a project takes shape, documentation needs are addressed at the earliest stages. Specific requirements are first evaluated and mapped to existing sources, and then a gap analysis is performed to identify special requirements. We listen to the Customer’s needs. The incremental review of key documents during design and construction synchronizes communication with the customer and prevents problematical and costly modifications in the final project stages. Custom Powder Systems completed Installation Qualification (IQ) and Operational Qualification (OQ) documentation and validation packages provide documented evidence that our systems are built and commissioned in accordance with user requirements (URS), functional specifications (FS), and FDA and cGMP standards.
The Documentation & Validation Group provides comprehensive documentation packages for the custom food, pharmaceutical, and process equipment manufactured by CPS. The documentation packages are classified as Turn-Over Packages (TOPs) and are used by the equipment owners to achieve validation for FDA and other regulatory environments.
A typical validation package includes:
- Installation instructions
- Operating instructions
- Maintenance instructions
- Welding records
- Material test reports
- Material traceability certificates
- Instrument calibration certification
- Component specifications
- Design drawings
- Functional Specifications (FS)
- Testing protocols
- Factory Acceptance Testing (FAT)
- Site Acceptance Testing (SAT)
- Installation Qualification (IQ)
- Operational Qualification (OQ)
We can also assist in the collaborative creation of custom documentation for special customer requirements.
Since our Validation/Quality Systems are integrated within the company structure, there are significant benefits realized from shared databases and concurrent learning curves. With these intrinsic efficiencies we have the ability to generate and execute FDA compliant qualification packages for our systems in a very timely manner, and at a lower cost than thirdparty contractors.