Digital signing according to CFR Part 11

Digital signing according to CFR part 11

For professionals in the pharmaceutical, medical device or food industries, regulation is a constant factor. When it comes to electronic records and signatures, 2021 CFR Part 11 is a term that inevitably comes up. But what exactly does this regulation entail, and how can one ensure that systems, such as an electronic signature solution, are compliant?

What exactly is CFR Part 11?

In essence, 2021 CFR Part 11 is a regulation issued by the US FDA (Food and Drug Administration). The primary goal is to ensure that electronic documents and signatures have the same reliability and legal validity as their physical, paper equivalents. In this case, for important documents such as clinical studies, production batches and quality documents. Integrity must be guaranteed at all times.

The essence of CFR Part 11 rests on two key pillars:

• Authenticity, integrity, and confidentiality of electronic records: It is essential that digital documents cannot be altered unnoticed and that changes are always recorded, with the secure storage of the documents being crucial.
• Reliability of electronic signatures: A digital signature must unambiguously confirm the identity and authority of the signer.

Non-compliance with these regulations is serious business and can result in audits, fines, and even the withdrawal of approvals.

A compliant solution

The crucial question then is: how can a digital signature solution meet these strict requirements? Let's take a closer look at the most important aspects:

• Waterproof audit trails:

What it is: CFR Part 11 requires a detailed, immutable log of every action performed with a document. This includes information about who opened, modified, or signed the document, and at what time.

• ValidSign: ValidSign accurately records every step, including timestamps, IP addresses, and user identification. This creates a robust and transparent audit trail that can be consulted at any time. Discussion about actions taken is thus excluded.
• Robust security and access control:

What it is: Preventing unauthorized access to sensitive documents or unauthorized electronic signatures.

• ValidSign: ValidSign implements powerful security mechanisms. Think of unique usernames, strong passwords and two-factor authentication, which guarantee that only authorized individuals can access their accounts and documents. This minimizes the risk of unauthorized access.
• Reliable electronic signatures:

What it is: An electronic signature must be inextricably linked to the signer and their intent.

• ValidSign: ValidSign assures that each signature is uniquely linked to the signatory and that the pre-signing authentication is robust. This ensures the integrity and legal validity of every digital signature placed through the platform. The identity of the signatory is therefore indisputable.
• Validation support:

What it is: For your own compliance, it is necessary to demonstrate that the systems used function correctly and deliver the intended results. This process is called validation.

• ValidSign: While the responsibility for system validation lies with the organization, ValidSign provides a stable and well-documented platform that facilitates the validation of processes.

A solid foundation for compliance

CFR Part 11 represents a serious, yet manageable challenge. By choosing a solution like ValidSign, an organization lays a solid foundation for compliance in digital signing within the pharmaceutical, medical, or food industries. This enables organizations to not only accelerate digital transformation, but also streamline processes while complying with regulations.

For more information on how ValidSign can support organizations with CFR Part 11 compliance, contact us for a demonstration, or schedule a call with our account manager right away.

##