21 CFR Part 11B Electronic Records

Keywords: FDA, CFR, part 11, imonnit, monnit,


Summary:

About 21 CFR Part 11B Electronic Records



It is more important than ever for companies to automate their record keeping practices. 21 CFR Part 11B was developed by the FDA in 1997 to keep your records safe and secure in the digital age. Monnit takes great pride in making sure the readings delivered by both our Standard and ALTA product lines are authentic, reliable, and confidential.

Devices in compliance with 21 CFR Part 11B are recognized for safeguarding sensitive information. All computer systems containing “records in electronic form that are created, modified, maintained, archived, retrieved, or transmitted, under any records requirements set forth in agency regulations.”1 For example, a temperature sensor used to monitor hot a hospital waiting room does not require 21 CFR Part 11B approval. However, a temperature sensor geared to make sure blood samples are kept cool in the same hospital may need to pass an audit.

Meets Electronic Record Authenticity Requirements

Authenticity requirements outlined by 21 CFR Part 11B include:

  • System consistently performs as designed.
  • System must have the capacity to identify invalid or altered records.
  • Sensor data is encrypted, stored redundantly, and cannot be modified after recording.
  • Sensor data is logged and time-stamped.
  • All data is backed up over distributed databases.

Monnit meets each of these guidelines. All sensors have been tested by professionals to make sure they perform under a variety of harsh conditions. The readings taken by sensors and stored on the online portal iMonnit cannot be altered once the data is recorded. Sensors can be ordered with traceable calibration certificates such as NIST or EN12830. All data is logged and time-stamped under the history tab in iMonnit for that specific sensor.

 

Meets Electronic Record Integrity Requirements

21 CFR Part 11B requirements are as follows:

  • Readable copies of records can be produced without impact on the original record.
  • Sensor data can be graphed.
  • Sensor data is time stamped.
  • Sensor data can be exported in spreadsheet/text form.
  • Sensor data can be exported using a secure API.

All sensor data is graphed and time stamped on iMonnit. These records can also be exported on the history tab while viewing that time stamped data. API calls can be accessed by going to https://www.imonnit.com/API where a vast amount of sensor processes can be accomplished.

Meets Confidentiality Requirements

iMonnit meets confidentiality requirements of CFR 21 Part 11B by satisfying the following requirements:

  • A username and password are needed for access.
  • Roles-based access can also be given to authorized users.
  • Logged data cannot be accessed by unauthorized users.
  • Customer data is separated by accounts.

No data on iMonnit can be accessed by unauthorized users. Username and password combinations are not shared between other users.  iMonnit is a secure cloud-based portal. Roles for multiple users on an account can be assigned by administrators right from their smartphone with a membership to iMonnit Premiere.

 

The FDA’s motto is “If it isn’t documented, it didn’t happen.” This is why accurate electronic records are so important. Software applications used to store these records must be able to validate data, have an audit trail, copies of records, and be able to retain archived readings. Monnit supports these requirements, making it the right choice for your CFR 21 Part 11B compliant processes.

 



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