21 CFR Part 11
Regulatory Compliance using Digital Operations Systems
Introduction
FDA 21 CFR Part 11 was established by the US Food and Drug Administration (FDA) to ensure the authenticity, integrity, and confidentiality of electronic records and electronic signatures.
This part of the regulation governs how electronic records and signatures are managed and utilized to ensure data integrity in Life Science industries, such as pharmaceuticals, medical devices, biotechnological, and other FDA-regulated industries.
On this page, we will discuss the different parts and requirements of the 21 CFR Part 11, and explain how TilliT supports life sciences manufacturers to ensure compliance as they transform from paper to digital processes.
What is 21 CFR Part 11?
21 CFR Part 11 denotes the eleventh section of Title 21 in the Code of Federal Regulations, established by the US Food and Drug Administration. These directives specifically address electronic records, including electronic batch records and device history records, along with electronic signatures. The aim is to establish criteria by which these digital compliance processes can be deemed as trustworthy as physical signatures on paper documents.
This segment of the regulations, known as Part 11, serves as a guide for manufacturers, focusing on the integrity and confidentiality of electronic data and documents. It creates a framework where parties involved can confidently acknowledge and validate electronic signatures without dispute.
In addition to electronic documents, this regulation extends its scope to encompass various forms of digital content, such as images, sound files, source code, and videos. Ultimately, 21 CFR Part 11 empowers life sciences manufacturers to streamline their processes, reducing the complexity associated with traditional paper document management.
Requirements
The requirements outlined in 21 CFR Part 11 establish the standards by which electronic records, electronic signatures, and handwritten signatures on electronic records are deemed trustworthy, dependable, and equivalent to their paper-based counterparts.
Data Integrity
Enterprises must establish digital procedures for data authentication and validation to guarantee its accuracy and reliability. This instils confidence in the generated, stored, and shared data, assuring its precision and authenticity.
Data Retrieval
Part 11 provides guidance to life sciences manufacturers on implementing secure protocols to safeguard and manage data during its creation. This facilitates convenient data access through indexing and archiving, streamlining both internal and external audit procedures for manufacturers.
Validation
The FDA requires manufacturers to verify the accuracy, reliability, and consistent performance of their systems as per their design. Manufacturers should provide comprehensive insights into the system’s operations, demonstrating the interplay of its components to achieve the desired outcomes.
Audit Trails
In accordance with 21 CFR Part 11, manufacturers must maintain a clear and complete record of documents associated with production. This practice ensures that auditors and regulatory entities have access to complete history, outlining any changes, including dates and the accountable individual.
Operational Controls
Part 11 outlines the FDA’s directive for manufacturers to employ operational system checks, ensuring the orderly progression of steps and events, such as gated workflows configured to track and control procedures.
Security Controls
Life sciences manufacturers are obligated to establish mechanisms that restrict document and document management system access exclusively to authorized personnel. These authorized individuals must possess distinct login credentials and passwords to document their access, ensuring that only relevant parties have access to secure information.
Digital Signatures
Each individual must possess a unique electronic signature, facilitating tracking and establishing responsibility. To this end, a digital signature should encompass the signatory’s name, the date of signing, and the rationale behind document authorization. Electronic signatures play a pivotal role in streamlining compliance processes, minimizing obstacles, and empowering manufacturers to create a coherent digital audit trail that facilitates seamless tracking by auditors.
Shared Responsibility Model
In the same way that paper forms alone do not create compliance unless backed by fully compliant processes, the compliance of digital systems also requires both software and configuration to work in tandem to achieve compliance. This is achieved via a Shared Responsibility Model, under which:
- TilliT is responsible for system capabilities required to support FDA 21 CFR Part 11 and is compliant when configured appropriately.
- Customer is responsible for configuring their implementation to meet all regulatory obligations.
Summary
For manufacturers in regulated industries, digital transformation programs must not only meet the future needs of the business. They must also ensure complete regulatory compliance, when moving from paper to digital.
In selecting appropriate digital operations platforms, it is therefore imperative that the solution can be configured to securely track and retain vital production data, establishing a digital record of activities that can withstand examination by regulatory authorities.
TilliT provides a cohesive digital operations platform incorporating scheduling, execution, traceability and quality, supported by the ability to meet typical regulatory compliance requirements.