WHAT WE DO
Validation
Documentation and validation for all BF Parma systems.
Each system and equipment includes a complete documentation package in accordance with GMP and customer’s requirements. All welding, mechanical parts, electrical parts, instruments and related endoscopies, samples, and certifications are archived for the actual weld book, mechanical book and electrical book.
Each system and equipment includes a complete documentation package in accordance with GMP and customer’s requirements. All welding, mechanical parts, electrical parts, instruments and related endoscopies, samples, and certifications are archived for the actual weld book, mechanical book and electrical book.
Hardware and software documentation is part of the control system package.
The validation approach complies with GMP requirements and includes: Design Qualification – DQ -, Factory Acceptance Test – FAT -, Site Acceptance Test – SAT -, Installation Qualification – IQ -, Operation Qualification – OQ – and Performance Qualification – PQ – .
A writing and execution protocol can be provided for all validation activities.
A writing and execution protocol can be provided for all validation activities.
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QUALITY
