Basics of 21 CFR Part 11 Compliance

insight inspecting underwrap vaccine kits and vials

Life science, biotech, pharmaceutical, and medical device companies are heavily regulated, and the framework for the proper management of digital records that could be submitted electronically in a regulatory FDA filing is 21 CFR Part 11, paralleled by Annex 11 in the EU.

As automation supported by sophisticated vision systems has become essential to the manufacturing of drugs and devices, Part 11 has become a topic of concern for quality managers worried that their processes may not be compliant.

Fortunately, ensuring compliance is simpler and more straightforward than generally realized, supports all other compliance requirements, and provides for best practice record-keeping procedures in general. Any manufacturer with an automated quality management system (QMS) that is Part 11 compliant will find that it generally enhances operations.

All that is required is a bit of extra attention to the specific requirements of machine vision systems.

Supporting the move to electronic records

The purpose of the regulation was to ensure security in how pharmaceutical, biotech, and medical device manufacturers managed their records. It provided a defined path away from expensive and time-consuming paper records and encouraged the shift to electronic systems while ensuring that the quality and safety standards for medications and devices were maintained.

The original regulation dates to 1997, and the FDA has periodically released clarifying guidance papers as technology changes and new questions arise.

21 CFR Part 11 in brief

21 CFR Part 11 deals primarily with the movement of paper-based records to electronic in manufacturing lines. The FDA has provided guidance on how to manage this documentation movement for biotechnology, drug, and medical device businesses with a set of procedures and requirements that could guarantee that their choices would be secure and compliant, without imposing excessive costs.

The specific section that applies to machine vision systems is Part 11, Subpart B titled “controls for closed systems.” It provides guidance in six main areas:

# Rule Description
11.10(a) Validation Validation of systems to ensure accuracy, reliability, consistency
11.10(b)(c) Record copies and protection Generate accurate copies of records suitable for inspection
11.10(d) System access Limit system access to authorized individuals only
11.10(e) Audit Trails Time-stamped records of operator entries and changes for electronic records
11.10(f) Operational Checks Enforcement of permitted sequencing of steps and events
11.10(g) Authority Checks Ensure only authorized individuals can use the system and access the operation of the system

The EU’s Annex 11 parallels Part 11, but while Part 11 is a requirement in the US, in the EU Annex 11 is intended as a guide. They have been harmonized, and systems that meet the requirements of one generally meet the requirements of the other.

Vision systems are essential to automation and track-and-trace

With increasing drug counterfeiting, unauthorized adulterations, and thefts and loss along global supply chains, verifying the location and identity of each drug has become a business imperative.

The US Drug Supply Chain Security Act (DSCSA) also makes it a compliance priority. It mandates a range of serialization, verification, and data exchange and storage guidelines for the industry. It requires the use of an electronic system to track drugs distributed within the US down to the unit level, a process called track-and-trace.

Vision systems are key to track-and-trace. They check whether each unit has been properly assigned a code and detect and record that code at every step of the supply chain. Serialization makes track-and-trace possible by requiring that every individual unit of a drug, in primary packaging, be identified with a unique serial and lot number and a matching GS-1 compliant barcode.

And these vision systems must be 21 CFR Part 11 compliant.

Many companies are apprehensive of how they will prove to regulators that their systems meet the standards the regulators will apply. What if they go through a lot of effort, only to be unable to prove they can do it? This is particularly true of vision systems, which have expanded dramatically, and often were not designed or planned with compliance at top of mind.

Key considerations for vision systems

Pharma manufacturers want to install vision systems on their lines to help with automation, but also want to stay compliant. Fortunately, automation and compliance work well together. There are a few considerations to keep in mind to meet both objectives.

At a minimum a vision system should, in addition to performing all of its required functions, be able to do the following to be 21 CFR Part 11 compliant:

  • Limit system access to authorized individuals
  • On request, efficiently locate the appropriate records and provide copies suitable for review
  • Use audit trails that record the date and time of every operator action and entry that creates, changes, or deletes an electronic record
  • Confirm the identity of any individual who electronically signs a record
  • Ensure that no change obscures data previously recorded

A smart vision system that does not require a PC for these functions is significantly easier to maintain. Building 21 CFR Part 11 compliance in from the start guarantees that serialization, track-and-trace, defect detection, and other processes can be fully automated while maintaining compliance.

Look for the best possible support

No matter what support vendors and third-party technical experts provide, a manufacturer is, in the end, responsible for its own compliance. Vendors can test, they can assist in validation, they can provide documentation—but they can never take the place of the manufacturer’s own quality system.

However, vendors who provide the proper technical support can make a compliance effort straightforward, and ensure that technical documentation supports the manufacturer’s compliance efforts. To learn more, download the 21 CFR Part 11 Whitepaper.

Alison Guzman

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