Any pharmaceutical or medical device manufacturer who does not use validated software, relies on costly manual and paper processes which may compromise the safety, quality and value of its products.
However, the software validation process can be extremely expensive and time consuming. Many companies employ full-time validation teams who are on a continuous global loop of validating and witnessing every computer system install and upgrade used in the production process – ‘the validation merry-go-round’. Validation establishes by objective evidence that all requirements have been implemented correctly, successfully and are traceable to systems requirements. Remember in the eyes of the regulators, if it’s not documented, then it’s just a rumor.
‘Reducing the Validation Merry-Go-Round – Lowering the time and cost of computer system validation while ensuring FDA compliance’ webinar explored how the validation merry-go-round can be dramatically reduced.
