Supporting cGMP compliance
DETAILED and comprehensive documentation is produced to aid the design process and support cGMP compliance.
This information is compiled in response to the client brief and provides a contractual framework, a fully developed scope of works and a defined performance specification.
Master Room Specification: Excel documentation that captures specific parameters pertaining to the design – such as room data sheets, equipment and utilities register, schedules for panels, doors, glazing, furniture & equipment.
Functional Design Specification: Outline of the design concept for all structural, mechanical and electrical systems, a guide to all material specifications selected for key components, with full list of appendices containing data sheets and performance data.
Design Qualification (DQ): For all cGMP projects a full design qualification can be produced in response to the URS outlining compliance to the brief whilst initiating a framework for the later commissioning stages of Installation Qualification (IQ) and Operational Qualification (OQ).
Stakeholder engagement is key to the success of the documentation phase, setting expectations early and involving the appropriate people from initiation ensures a smooth process and a project file that meets the needs of the business from a compliance and audit perspective.
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