Software used in quality, regulatory, development and manufacturing by a medical device manufacturer may affect the quality of the end product or service. Therefore, it needs to be validated for its intended use. This includes software for design, development, complaint handling, document control, etc.
QAdvis has expertise in all aspects of computer systems validation. We have long proven experience in planning, execution, concluding and documenting the results. We can design the strategy to complete your computer systems validation activities in a timely and compliant manner, and effectively manage all activities related to these three phases. Our reference material is GAMP V or AAMI TIR 36, ISO/TR 80002-2 depending on your needs.
We support you with:
Validation, including risk assessment
Establishing or improving company procedures
Incorporating procedures in an overall QMS structure
Establishing and executing master validation plans
Validation templates, protocols, reports, etc.
Validation project management support
Contact me for further information Robert Ginsberg
Office +46 8 621 01 05 or send me an mail