Compliance and Transparency
Because an audit may be right around the corner.

When it comes to tech in the Pharma and Clinical space, quality is of paramount importance – and that means transparency and compliance for your technology program. Electronic systems and records in this space are governed by 21 CFR Part 11 or EU Annex 11 for those doing business in Europe.

Keeping your systems up to date isn’t going to be enough to prevent a finding or the dreaded 483 letter from the FDA. Qualifying and validating your electronic systems for security and redundancy as well as training your users are vital. And documenting those qualified procedures are important not just for audits, but quality and safety for you, your employees, and your customers.

In the words of Henry Ford,

Quality means doing it right when no one is looking.

How we can help
  • Technology program assessment and recommendations
  • SOP and policy suite creation
  • User Training
  • 21 CFR 11 / EU Annex 11 compliance assessment