With every trip to our local pharmacy, grocery store or corner variety shop, we pass hundreds of products that have reached the shelves only after a lengthy process designed to ensure their quality.
It’s not something the everyday consumer thinks much about. But without this crucial element of the manufacturing process, we would never be able to trust the quality of the many products whose high standards we take for granted. It’s quite easy to envision the catastrophes that would result.
Core to the process of ensuring quality is the concept of validation. This is the process whereby pharmaceutical manufacturers provide objective, documented evidence that their processes, equipment and computerized systems are checked and validated to ensure the quality of their medicines and medical devices.
Central to the validation journey is the required documentation produced with each step. To satisfy regulators, companies must record evidence to prove what work was done and when, including elements such as designs, tests and test-script executions.
This process was primarily a paper-based one until the 1990s, when software and spreadsheets began to rule the landscape. In today’s well-established Internet age, a new model has emerged, known as the Cloud model.
In partnership with subject matter expert Ray Glemser of Glemser Technologies, Intelex has created The Definitive Guide to Validating Your QMS in the Cloud. It provides an in-depth look at how this exciting new model works and the many improvements it offers manufacturers charged with validating their QMS and ensuring product quality. Get your free copy today.