How to Stay Compliant with 21 CFR Part 11

How to Stay Compliant with 21 CFR Part 11

April 8th, 2013 // 7:42 pm @

April 8, 2013

We all know we need to stay in compliance with all aspects of cGMP guidelines, but few FDA compliance subjects are more asked about than 21 CFR Part 11. According to some reports, the cost of complying with this FDA regulation can range from $5 million to more than $350 million, all depending upon how large your company is and the status of your computer systems.

April 30 – Prepare Yourself for 21 CFR Part 11 Inspections

If your company has computer systems that are not compliant with 21 CFR Part 11, you are going to need to prioritize which systems are most important to upgrade. The best way to do this is to use a risk-based methodology to give you a strong compliance road map.

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The cGMP regulations are the basis for the Part 11 guidelines. For you to comply with cGMPs, you need to record, track, manage, store and access many types of production documents and their change history in these areas:

  • SOPs
  • Master Production Batch Records
  • Equipment Logs

Back in the old days, all of these documents were kept on paper by most companies to comply with GMPs. The Part 11 guidelines describes the controls to make sure that all electronic records and signatures are completely reliable and trustworthy.

April 30 – Prepare Yourself for 21 CFR Part 11 Inspections

The Part 11 guidance provides several requirements for compatible software systems that will allow electronic records to be both trustworthy and reliable. If the software does not meet FDA requirements, the agency will cite you in a 483 for a violation of the underlying cGMP regulation.

Some of the most important software requirements for 21 CFR Part 11 are:

  • System validation to make sure performance of the system is accurate and reliable.
  • System should be able to produce accurate/complete record copies that are readable both in human and electronic forms.
  • Record protection to ensure they are accurate and able to be retrieved easily.
  • System access should have strong controls to prevent unauthorized access.
  • Must have time stamped audit trails.
  • Operational system checks must be in place to ensure proper sequencing of steps and events.
  • Authority checks must be in place to make sure that only the authorized personnel can get into the system.
  • Proper controls on system documentation
  • Written policies must be produced that hold everyone accountable for any actions that occur after their electronic signature.

April 30 – Prepare Yourself for 21 CFR Part 11 Inspections

Risk Road Map

Compliance based upon a risk assessment starts with inventorying all computer systems, and also figuring out which systems are just paper based or are not compliant. Analyze each system to determine risk, and also how much it costs to convert the paper system to an electronic system.

A key part of determining the risk involved is to assess a the potential impact of a system on consumer safety. Also, determine the risk relating to failure potential of the system. And the company needs to think about intervention risk by FDA and what might happen if there were a fine or drug approval delay or consent decree.

One of the most common things to upgrade is the quality management system so that it is part 11 compliant. These systems give an infrastructure for all electronic records for training and SOPs. These systems are thought of as critical by FDA, as their failure will definitely affect product quality and cGMP compliance.

Some of the systems that you will need to upgrade to be part 11 compliant in your quality system include:

  • Document management/control
  • Management of audits
  • OOS
  • CAPA
  • Change control
  • Employee training
  • Calibration of equipment

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