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FEATURE SPOTLIGHT

Title 21 CFR Part 11 Compliance

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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"This amazing product enables us to collect various field data, feed it into our corporate EH&S and Asset Management systems, saving a lot of time and effort. The forms are easy to build and intuitive to use. This is a really well thought-out and designed product."
OLEKSIY GOLOVCHENKO
SR. AIR COMPLIANCE SPECIALIST
ENCANA
Rating: 4.5/5
220+ reviews
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