GR Documentation
In a cGMP environment, documentation must meet specific requirements to ensure both product quality and safety. Regulations from the FDA, PIC/S, and EU all include mandatory sections regarding these essential documents.
Engineering Drawings
Our comprehensive drawing packages ensure complete transparency and technical accuracy for every installation:
General Assembly: Assembly and erection drawings, including general assembly and equipment support details.
Process & Layout: Process & Instrumentation Diagrams (P&ID), schematic and piping arrangements, and necessary layouts.
Technical Systems: Electrical and pneumatic drawings, data sheets, loop diagrams, and drawings for Air Handling Unit instruments.
Final Verification: Final As-built drawings and contact surface area drawings.
Quality Certificates & Reports
We provide the necessary verification to prove material integrity and instrument accuracy:
Material Integrity: Material of construction (MOC) reports and certificates for all direct and indirect product contact surfaces.
Verification: Instrument calibration reports or certificates and integrity test certificates.
Guarantees: Warranty and guarantee certificates for both the main equipment and all bought-out items.
Protocols & Qualification Documents
Our validation support package is designed to meet the most rigorous regulatory audits:
Factory Acceptance Test (FAT): Detailed protocols for initial performance verification at our facility.
Validation Core: Complete Design Qualification (DQ), Installation Qualification (IQ), and Operation Qualification (OQ) documents.
Standard Procedures: Recommended SOPs for operation, cleaning, and maintenance, along with installation instructions and guidelines.
Operation & Maintenance Manuals
Detailed guidance is provided to ensure smooth equipment operation and troubleshooting:
Main Equipment: Comprehensive operation and maintenance manuals for the main equipment and all major components.
Bought-out Items: Manuals for all integrated third-party components.
Software & Controls: Software manuals, ladder logic/operation and controls documentation, and instrument manuals.
Support Guides: Equipment manuals with troubleshooting guides and interlock description flow charts for maintenance.
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