Ensuring 21 CFR Part 11 Compliance in Regulated Businesses

Businesses regulated by the Food and Drug Administration (FDA) are well aware of 21 CRF Part 11. However, it’s often misunderstood and causes confusion.

We explain what it is, its relevance today, why ensuring 21 CFR Part 11 compliance in regulated businesses is essential and how to achieve it.

What is 21 CFR Part 11?

Part 11 of Title 21 of the Code of Federal Regulations (CFR) defines the criteria for acceptance by the FDA of electronic records, electronic signatures and handwritten signatures executed to electronic documents.

It defines the criteria under which they’re considered authentic, trustworthy, reliable and equivalent to paper records. The regulation is divided into three parts: general provisions, electronic records and electronic signatures.

Relevance of 21 CFR Part 11 in regulated industries

When 21 CFR Part 11 was first launched by the FDA in the 1990s, records and management systems were largely paper based in regulated industries.

Now, more than 30 years later, all organizations use digital technology.

The transformation and widespread adoption of electronic data and record keeping means 21 CFR Part 11 is more relevant and necessary than ever for regulated industries.

While Part 11 doesn’t insist on the use of digital records, it was introduced to allow their use while preventing fraud and safeguarding the integrity of data and systems, and the validity of electronic signatures.

Compliance with 21 CFR Part 11 includes ensuring the control and identification of records and system documentation, the accurate and ready retrieval of records, limiting system access to authorized individuals, and preventing methods to falsify records.

Risks and consequences for non-compliance

While 21 CFR Part 11 broadened the scope of regulations, the FDA has also tightened enforcement. Inevitably, this puts many organizations at risk of non-compliance.

Citations for non-compliance, especially in the areas of system validation and protection of records, can result in:

FDA Form 483s
warning letters
an injunction in the form of a market recall
a ban on importation and distribution.

The outcome of any citation can be very costly, both financially and to an organization’s reputation.

Citations can result in direct and indirect penalties, and reduced revenues. The FDA may consider revenue procured during non-compliance as illegal and seize it.

The adverse publicity surrounding citations often negatively impacts a company’s stock value.

6 ways to ensure 21 CFR Part 11 compliance

1. Know and understand predicate rules

All regulated businesses must know and understand the predicate rules – the FDA regulations – that apply to their particular industry and that lay the groundwork for compliance with Part 11.

The predicate rules detail the kind of records required and the signatures needed to validate them.

2. Enforce strict user ID security controls

To be Part 11 compliant, system software must limit and control user access with strict security controls, such as complex and unique usernames and passwords.

3. Generate detailed audit trails

Your organization must be able to provide regulators with an audit trail – a chronological record of all operations.

This audit trail is a series of documents or document archive that allows reconstruction of the course of events. All changes – modifications, updates and deletions – and every transaction made in the system database must be recorded.

Your internal system software must be able to keep a daily record of all functions and generate this audit trail, which can authenticate and confirm the integrity of regulated records and signatures.

4. Ensure secure data transfer

To be Part 11-compliant, FDA-regulated businesses must ensure secure data transfer in all electronic systems.

This includes controlling and limiting delete capabilities, encrypting all data transferred outside the intranet firewall and taken offsite, and making sure systems enforce the correct sequencing of events and unambiguous date sequences.