A View from Europe – Managing Validation Processes Electronically

In Europe, we are seeing in the field more and more life science companies looking to manage their validation processes electronically. In the life science industry, most processes and related IT systems must be validated and documented. As many organizations’ validation processes are still paper based, companies often spend a great deal of time and manual resources preparing, controlling, approving and archiving validation documents and records throughout the entire validation life cycle. Traditional electronic document management systems (eDMS) and test management systems do exist - and some life science companies try and cope with their validation processes using them. However, these systems don’t have a record approach and are not process driven. Therefore having eDMS alone to track and manage the complete validation life cycle with the different validation phases, document packages, related deviations and follow up actions is extremely difficult, and nearly impossible.

When managing and tracking validation processes electronically you get a real-time view of the validation status; all validation documentation is available online and periodic reviews are scheduled automatically, reflecting validation status. Also, statistical validation data for all processes can be compared globally with the option to see validation status with varying levels of detail, including drill down options from one level to the other (corporate to country to site etc…).

Bottom line: More than ever, companies in Europe are looking to manage validation processes electronically to enhance quality and reduce costs. With an electronic validation system documents are no longer lost or missing signatures, regulatory compliance is improved and fewer man-hours are spent on documentation. It’s the way to go.

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