GCP Compliance Hack: How To Avoid The Most Common Warning Letter Trigger

By James Jardine

If clinical personnel are working at a variety of different sites and utilizing different disconnected systems to record and share data, establishing a single source of truth is impractical, if not impossible. There are bound to be inconsistencies across multiple sites and studies if there isn’t a centralized source of accurate, up-to-date data. Maintaining quality standards effectively becomes impossible if data reliability is questionable.

A centralized digital system can connect and synchronize data, which enables clinical professionals to better manage quality events that occur across studies and product lines. A digitally connected system also improves their ability to effectively steer actions that should be taken when deviation issues are identified.

Digitization streamlines every process related to GCP compliance, but there are five essential clinical areas that digital connectivity can enhance dramatically.