Feature Spotlight
Title 21 CFR Part 11 Compliance
FEATURE
HIGHLIGHTS
FEATURE HIGHLIGHTS
- Comply with US FDA regulations
- Collect e-signatures from stakeholders
- Generate clear audit trails
THE PROBLEM
Organizations involved in the servicing and upkeep of pharmaceutical, healthcare, or laboratory equipment must maintain meticulous service records and are bound under FDA rules to comply with Title 21 CFR Part 11.
For these field service teams, using a non-Part 11 compliant solution for e-signatures simply isn’t an option.
They must be able to not only prove their digital records are compliant but also have controls in place to ensure the integrity and security of electronic records and e-signatures (ERES) as they are collected and stored.
OUR SOLUTION
Field teams can now use ProntoForms’ mobile form apps to capture ERES in compliance with Part 11. This means:
This leads to:
- ERES are validated to ensure accuracy, reliability, consistency, and the ability to discern valid or altered records
- Teams responsible for compliance and regulatory reporting can generate complete copies of records in both readable and electronic form suitable for inspection, review, and copying by the FDA
- Secure, computer-generated, time-stamped audit trails can track admin entries and actions that create, modify, or delete ERES
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