BASICS OF 21 CFR PART 11 COMPLIANCE

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

 

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

 

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

 

All that's required may be a little bit of extra attention to the precise requirements of machine vision systems.

 

Supporting the move to electronic records

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

 

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

 

21 CFR Part 11 in short

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

The EU’s Annex 11 parallels Part 11, but while Part 11 may be a requirement within the US, within the EU Annex 11 is meant as a guide. they need been harmonized, and systems that meet the wants of 1 generally meet the wants of the opposite .

 

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 situation and identity of every drug has become a business imperative.

 

The US Drug Supply Chain Security Act (DSCSA) also makes it a compliance priority. It mandates a variety of serialization, verification, and data exchange and storage guidelines for the industry. It requires the utilization of an electronic system to trace drugs distributed within the US right 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 availability chain. Serialization makes track-and-trace possible by requiring that each individual unit of a drug, in primary packaging, be identified with a singular serial and lot number and an identical GS-1 compliant barcode.

 

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

 

Many companies are apprehensive of how they're going to convince regulators that their systems meet the standards the regulators will apply. What if they are going through tons of effort, only to be unable to prove they will do it? this is often particularly true of vision systems, which have expanded dramatically, and sometimes weren't designed or planned with compliance at top of mind.

 

Key considerations for vision systems

Pharma manufacturers want to put in vision systems on their lines to assist with automation, but also want to remain compliant. Fortunately, automation and compliance work well together. There are a couple of considerations to stay in mind to satisfy both objectives.

 

At a minimum a vision system should, additionally to performing all of its required functions, be ready to do the subsequent to be 21 CFR Part 11 compliant:

 

• Limit system access to authorized individuals

• On request, efficiently locate the acceptable records and supply copies suitable for review

• Use audit trails that record the date and time of each operator action and entry that makes , changes, or deletes an electronic record

• Confirm the identity of a person who electronically signs a record

• Ensure that no change obscures data previously recorded

A smart vision system that doesn't require a PC for these functions is significantly easier to take care of . Building 21 CFR Part 11compliance in from the beginning guarantees that serialization, track-and-trace, defect detection, and other processes are often fully automated while maintaining compliance.

 

Look for the simplest possible support

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

 

However, vendors who provide the right technical support can make a compliance effort straightforward, and make sure that technical documentation supports the manufacturer’s compliance efforts. to find out more, download the 21 CFR Part 11 Whitepaper.