Why Implement an FDA 21 CFR Part 11 Software System

To be compliant with US FDA 21 CFR Part 11 regulations, CFR Part 11 validation of electronic data management systems is mandatory. In simple terms, any computerized system involved in the clinical research process must comply with FDA 21 CFR Part 11.

What is US FDA 21 CFR Part 11?

It is basically part 11 of Title 21 of the Code of Federal Regulations. This sets rules as to how any company implementing digital signatures and electronic records capturing or dealing with clinical data must comply with FDA regulations.

Established in 1996, Part 11 has had several versions released to keep abreast of the technology. The primary motive of this regulation is to ensure the security of data records and management of storage, retrieval, and distribution of sensitive and confidential digital records.   

 Benefits of FDA 21 CFR Part 11 validation

 A paper-based system is not practical for a company who has branches worldwide. Data access across multiple offices by multiple staff is possible only through a robust and reliable electronic system. Some requirements of maintaining electronic records as per FDA regulations are:

System Validation

A prerequisite of part 11 is a validation of the electronic systems to maintain accuracy, consistency, and reliability of data.

All elements and their functions are clearly defined. Validation also calls for the system owner to maintain all documentation of the requirements and testing.

Record Generation

All records prevalent in the system will be accurate and easily retrievable. Part 11 requires that records must have an index and search facility with results showing the entire access history along with digital signatures.  

Audit Trials

Audit trails are secure and time-stamped ways to keep track of date/time of actions that edit, delete or modify data records. All processes are well-documented and have an audit history for audit trials to be successful.

Operational Checks

Operational system checks are performed to ensure that crucial system functions are in sequence. A proper workflow is followed for all operations. Data entry precedes its review. Quality checks are in place and all documents are reviewed by assigned individuals before they are approved.

 Security Checks through electronic signatures

Entry and access to the electronic system are controlled via login ids, passwords, and digital signatures. The system will specify the number of people authorized to modify the records. This information must be tracked until the final version is locked in.

Digital or electronic signatures are a significant part of FDA 21 CFR Part 1. A digital signature is computed based on the authentication of the originator, determined by a certain set of rules. This ensures verification of the identity and integrity of the data. The system administrator can grant and revoke digital signatures to prevent fraud.

 Training

Part 11 also requires that all users of the electronic data system are provided with enough training to perform their designated tasks. All users and their training procedures must be documented. 


Although FDA 21 CFR Part 11 compliance is a complex task, it helps to simplify the complex electronic system maintenance. Implementation of the FDA 21 CFR Part 11 software system will be worth the investment as it will bring in significant efficiency to the whole development process.