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Reduce Change Control Requirements

Reduce Change Control Requirements

Postby Unidec » Sun Jun 30, 2013 11:18 pm

Unidec can help reduce or in some cases elliminate change control requirements by limiting the methodology, scope and complexity of modifications to systems.

We do this by helping pharmaceutical manufacturers extend end-of-life support on validated systems thereby allowing them to keep their older systems in place and avoid the long, costly process to do the typical user requirement specification (URS), functional requirement specifications (FRS), detailed design specifications (DDS), factory acceptance testing (FAT), site acceptance testing (SAT), installation qualification (IQ), and operational qualification (OQ) and process qualification (PQ) to validate a new replacement system.

Our methodology of support includes a risk-based approach to hardware support that involves developing a comprehensive bill of material (BOM) database (DB). The BOM DB helps identify all of the critical system components, their risks to sourcing and assignment of risk factors to make decisions on procuring critical components. We are able to source many critical components and offer delivery or consignment of the same.

In addition to sourcing critical system components, we offer a comprehensive support program for many system components including items such as process controllers, power supplies, servo systems, vision systems, PLCs and other electronics equipment. We perform comprehensive repair, rebuilding and refurbishment of electronics. We fully functionally test, perform verified images of software and firmware to ensure continuity. All repairs include as-found and as-left documentation, traceability information and we adhere to our own quality management system (QMS).
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