Introduction
In the current marketplace, where digitization has taken the lead, organizations are digitizing their records, workflow, and signatures. The main problem that lies with digitization is the integrity, authenticity, and trust in the data, records, and signatures. This becomes more important, particularly for regulated industries like pharmaceuticals, biotechnology, medical devices, life sciences, etc.
21 CFR part 11 requirements are established by the FDA(Food and Drug Administration) to provide integrity and trust in electronic data and signatures to be followed by regulated industries. Many enterprises use secure electronic signature solutions to meet these FDA compliance standards while maintaining operational efficiency.
This guide will take you into 21 CFR Part 11 electronic signature requirements, meaning, compliance practice, and more.
What is 21 CFR Part 11?
21 CFR Part 11 is part of the US Code of Federal Regulations to establish rules for the use of electronic records and signatures. The main goal of this rule is to ensure the integrity, authenticity, and confidentiality of electronic records and signatures equivalent to the reliability of paper-based records. It covers electronic records that are created, stored, modified, transmitted, or accessed within the FDA’s authority by regulated industries.
21 CFR Part 11 requirements apply to all companies that submit their documents to the FDA or maintain records that are required to be inspected by the FDA, such as pharmaceutical, clinical research organization (CRO), biotech, medical device manufacturer, etc.
The two main components of this regulation are;
Electronic records that ensure how they are stored, created, modified, maintained, retrieved, protected, and managed.
Electronic signature that defines how electronic signatures can be as legal and binding as handwritten/manual signatures.
Electronic Signatures Under 21 CFR Part 11
Electronic signatures under 21 CFR part 11 are considered a digital representation of an individual’s intent to sign a document electronically.
This signature should not be an electronic marking but should meet strict standards as defined by the FDA to make it more secure, traceable, accountable, and trustworthy, which is as legal and equal to a handwritten signature.
This signature should also have the signer’s identity, which links the individual to their signature and electronic records to prevent unauthorized access and tampering.
21 CFR Part 11 Electronic Signature Requirements
The FDA has made specific regulations and key requirements for the use of electronic signatures by regulated industries. Here is the list of such requirements:
- Signature uniqueness
Each signature has to be unique for each individual, which cannot be reused or reassigned. This will ensure accountability of each signature, action, or approval.
- Verification of identity
The organization should verify the identity of the individual before assigning an electronic signature to confirm that only authorized individuals can use their credentials for signing.
- Identification Components
If the signatures are non-biometric, then there should be at least two distinct identification components used to reduce the risk of unauthorized access or forged signing, like:
- A unique User ID and
- A PIN or Password
- Signature Manifestation
Each electronic signature should display the full name of the signer, date and time of signature, and reason behind signing, such as approval, verification, or review, etc, to support transparency during audits and investigations.
- Signature linked to records
Each electronic signature has to be permanently linked to its corresponding records to ensure the signature cannot be copied, excised, or transferred to falsify another record.
- Password and Credential Security
There should be a policy for password creation, change, expiration, and protection to avoid unauthorized use. If the electronic signature is compromised or inactive, it should be permanently and immediately deactivated.
- Certifications
The electronic signature should be FDA-certified to make it legally equivalent to a handwritten signature.
Key Differences: Electronic Signature vs Digital Signature
Even though electronic signature and Digital signature are used interchangeably, there is a difference between the two terms. We shall have a brief understanding of both terms here. However, for detailed knowledge, visit our blog on Digital signature vs Electronic signature.
Electronic signature
An electronic signature is a broad term that covers any electronic process or means to indicate approval or agreement, such as a typed name, a scanned image of a signature, clicking “I agree”, etc.
Digital Signature
Digital Signature is a specific type of electronic signature which uses encryption, public key infrastructure, digital certificates, etc, to ensure security, identity verification, and document integrity.
In short, all digital signatures are electronic, but not all electronic signatures are digital. However, digital signatures are considered more secure and validated by trusted authorities, while electronic signatures have fewer security features.
Common Compliance Mistakes to Avoid in 21 CFR part 11 electronic signature requirements
Some common mistakes organizations make that compromise electronic signature compliance are:
- Lack of periodic testing of electronic system performance and incomplete validation to confirm accuracy.
- Lack of SOPs or inconsistent SOPs that don’t align with regulatory requirements.
- Non-verification of third-party vendor tools and their compliance.
- Poor training among employees will compromise compliance control, allowing password sharing, account sharing, weak passwords, or a lack of authentication.
- Lack of proper retention of signed records securely for the required period.
Compliance Best Practices for 21 CFR part 11 electronic signature requirements
Considering the above challenges, the organization should follow the undermentioned practices for compliance with 21 CFR part 11 electronic signature requirements.
System Validation
There should be a periodic review to determine the system performance that handles electronic records and signatures, and maintain validated documentation that provides information about system test results, user acceptance, and changes required.
Access control
There should be role-based access control, which ensures that only authorized persons can access the system and use the signature.
Standard Operating Procedures
The organization should develop SOPs that cover password management policies, record management, signature creation, and data security, and ensure that the SOPs are strictly followed.
Employee training and awareness
There should be proper employee training and awareness about 21 CFR part 11 electronic signature requirements to avoid human errors.
Audit Trail
There should be an activity log of each action taken or changes made, including details of who made the changes, when, and why, to stay audit-ready.
Vendor and software evaluation
When a third-party electronic signature solution is used, it is important to evaluate vendor compliance and ensure that the software is in alignment with 21 CFR part 11 electronic signature requirements, along with documentation and certification.
Conclusion
As organizations move to digital records and signatures, they should follow the 21 CFR Part 11 electronic signature requirements. A compliant, validated, and secure electronic signature system improves operations, increases transparency, and builds trust with regulators. This approach also makes sure that innovation and integrity go hand in hand. It allows organizations to maintain high standards of integrity and accountability.