21 CFR Part 11 may be complicated, but it's also non-negotiable. Your regulated systems are either compliant, or they need to become that way in a hurry. We can help.

Cegedim Dendrite's seasoned team of compliance professionals provide onsite assessment audits and reviews that quickly identify any gaps or potential issues affecting your Part 11 compliance status. Our regulatory assessments consist of a thorough examination of your system(s) functionality, as well as associated internal procedures and processes for development, maintenance, and implementation. To help you quickly resolve Part 11 shortcomings, we provide "recommended action plans" that reflect our extensive validation experience and our familiarity with your operational requirements. As a result, you mitigate your PDMA compliance risks, while maintaining the operational efficiencies that prompted you to develop an electronic capability in the first place.