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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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"Karen and Danny have been a huge help implementing Prontoforms and Analytics within our Division. We began with Safety audits and reporting and are now expanding into the area of Quality audits and beyond. This implementation and expansion has not only made us a more cutting edge company in the realm of Safety but our endeavors have also begun to be noticed by our sister divisions within our company as well as being looked at as part of a possible solution for other area projects."
JEANNE BUTZ
SONOCO DISPLAY AND PACKAGING
Rating: 4.5/5
220+ reviews
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