Validations

QUALITY MANAGEMENT

Validations

At Sheffield Precision, we pride ourselves on adhering to the highest standards of quality and compliance. As part of our commitment to excellence, we conduct thorough validations across three key areas outlined by medical device manufacturing directives.

  • We ensure that all our machinery undergoes vigorous installation qualification to guarantee proper setup and configuration for optimal performance. 
  • Our special processes, whether conducted in-house or externally, undergo comprehensive validation including installation qualification, operational qualification, and performance qualification. This ensures the integrity and reliability of these processes throughout their lifecycle. 
  • We prioritize the validation of software systems that impact production and manufacturing processes. Through stringent testing and validation procedures, we ensure stability, functionality, and compliance of software applications utilized in our operations. 
  • All testing performed is meticulously documented and readily accessible, including our regularly maintained Master Validation Plan. Our dedicated quality team is trained to efficiently retrieve and share these documentations, empowering you to meet your MDR needs with confidence.

At Sheffield Precision, our dedication to validation across these critical areas underscore our unwavering commitment to delivering superior quality and compliance in every aspect of medical device manufacturing.