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21 CFR Part 11 Compliance


April 06, 2021

Cleanrooms for medical device and pharmaceutical manufacturing are highly regulated spaces and there are numerous standards that need to be considered. When it comes to how data is handled in regulated cleanroom environments, the United States FDA issued 21 CFR Part 11 guidance that should be followed closely.

Overview

Environmental data monitoring and recording is often a manual, human-centric process. As such, there is a higher risk of errors or inconsistences in the collected data. Additionally, a manual process often produces paper records, which have many drawbacks, including:

  • Illegible data entries for data, date, time and signature
  • Inconsistent data recording intervals
  • Paper copy can be misplaced or damaged

However, the trend in cleanroom monitoring is moving toward electronic, continuous monitoring solutions that put data integrity first. A software based continuous environmental monitoring solution eliminates many of the potential issues associated with manual monitoring. A software based continuous environmental monitoring solution provides:

  • Consistent data entry and robust audit logs
  • Real-time notifications of environmental parameter deviations
  • Secure access to and retention of data for 10+ years to support regulatory audits

Scope

FDA 21 CFR Part 11 focuses on how electronic records should be both created and preserved for accuracy and integrity when it comes to continuous environmental monitoring. Requirements for compliance to 21 CRF Part 11 include:

  • Secure systems for record generation and storage
  • Automatically created time-stamped records
  • Easy retrieval of records for audits

21 CFR Part 11 applies to cleanrooms with any systems that involve the creation or use of electronic data. For compliance, an environmental monitoring system must:

  • Be validated frequently
  • Have secure computers and databases to prevent tampering
  • Record date, time, and personnel of each entry
  • Mark all data changes in case of error
  • Allow for easy review of metadata for entries

Compliance

21 CFR Part 11 applies to a number of industries including pharmaceuticals, medical devices, and food products. Companies to which 21 CFR Part 11 applies, as well as related businesses, must guarantee both electronic records and signatures are accurate and reliable.
As a US Federal regulation, 21 CFR Part 11 covers the following to guarantee accuracy and reliability of electronic records:

  • Digital quality/product records
  • Digital approval records

SetraCEMS

Setra CEMS can help regulated manufacturing spaces comply with 21 CRF Part 11. CEMS provides an audit trail for updates to records which have been created or modified providing visibility to all data changes. In addition, CEMS complies with 21 CFR Part 11 by having:

  • Electronic signatures
  • Audit logs
  • Password protected access
  • Secure retention of past records

Equivalent Regulations

EMEA Guidelines to Good Manufacturing Practice: Annex 11 (European Union)

Both discuss created and stored electronic records in cleanrooms. Annex 11 is information on operating in a compliant space, while Part 11 focuses more on prohibiting actions. The biggest differences are how personnel needs to be identified and liability for exploitation of data access.

ERES Guideline: Application for Approval of Licensing of Drugs (Japan)

ERES closely matches 21 CFR Part 11. US companies complying to Part 11 will also comply with ERES; Japanese companies will need to make sure they adhere to all Part 11 guidelines to sell in the U.S.

Food & Drugs Act, Division C.02 (Canada)

Unlike Part 11, Canadian regulations specify the responsibility for compliance rests on individuals. These regulations take into account Mutual Recognition Agreements with countries with equivalent standards, which make importing and approving materials and products across borders.

Topics: Critical Environments, Compliance, Cleanroom Monitoring