Pharmaceutical

The Pharmaceutical Industry is an environment where compliance and patient safety are absolutely critical. Compliance models from the FDA and 21 CFR Part 11 are achieved using our very configurable Workbench Professional software as the FRAMEWORK.

Rule 21 CFR Part 11 makes electronic records equivalent to paper records and handwritten signatures. The rule applies to all industry segments regulated by the FDA that include good laboratory practice (GLP), good clinical practice (GCP), and current good manufacturing practice (cGMP). The regulation establishes requirements to ensure that electronic records and signatures are trustworthy, reliable, and equivalent substitutes for paper records or traditional handwritten signatures.

For any drug research and development a Pharmaceutical company needs to demonstrate strict document control and process management. To serve domestic and international markets they must ensure compliance with these standards.

Workbench Professional helps manage compliance within the pharmaceutical industry by:

Forcing users to electronically sign documents at every stage
Keeping a complete history of every significant action performed on documents
Driving activity within the organisation

Workbench provides the administrative framework for your SOP’s, processes, procedures and documents. Notifications are managed using the systems internal task and notification structure. This can be linked to your internal email system to help drive activity in your organisation.