What is CSV:
Computer System Validation is the process of providing documented evidence stating that an electronic system or technology will perform as intended.
Heavily regulated industries:
The organizations falling into Finance, Life Sciences, Healthcare, Pharmaceuticals and Software are few sectors but not limited to that complies with regulations followed up with validations and audits.
What is FDA 21 CFR part 11:
It’s a set of laws binding and ensuring companies maintain, follow and implement the good business practices in their process throughout the operations. Part 11 allows a company to implement computer systems with a motive to increase the efficiency of individuals, mitigating errors, identifying risks and escalating the overall productivity of the organization while adhering to highest standards and Quality.
Code of Federal Regulation (CFR) has framed rules and regulations that refers to records and approval signatures that originally refers to paper documents and handwritten signatures. So, the part 11 allows the replacement of the paper records and handwritten signatures with the electronic record and electronic signature.
Here, the catch is about the rapid evolution in computer technology that has left the law forming agencies in total unstable mode, where the brainstorming for formation and restatement has become the daily activity and release of the updated notes to the public. The ever evolving technology has left many old way of regulations dead and would need reengineering the laws for electronic record for its credibility, security and authenticity.
It would really be nice enough for experienced person from various domains to add values to the regulatory body by sharing the ideas and projections. As in coming years, we would be seeing a lot of changes and revolutions.
21 CFR part 11 has following primary pillars as;
There are plenty of SOPs for IT infrastructure that must be taken care. Since the move from paper based to computer systems reflects that the process, operations and other management and authentication would heavily be depended on the computer system, where the repeated tasks are being governed by the few lines of codes that helps in data capture, data validation, data authentication, system authentication etc. So, to comply with computer system validation, Data Security, Data Backup, CSV, other integrated devices that are used in capturing data or scans of human body parts must have a validated process. These all at the end helps in forming an electronic record authenticated by electronic signatures.
- Features of the System:
Computer Systems would ensure the data integrity for electronic data and electronic signature by having a strong set of mandated features like, audit trails, electronic signature validation, password validation and expiry rules, system login with verification or Single Sign On (SSO), stashing of the data post archival of the project to a secured server etc.
Computer System Validation is the process of providing documented evidence stating that an electronic system or technology will perform as intended. Risk-based approach for Computer System Validation has always been the best practice in industries to have greater results in terms of efficiency and cost monitoring.
There are various source files and other relevant files and documents that must be associated with the evidence of documents while handling any computer system. Documents could be as follows but not limited to;
Risk Assessment, Scope, Detailed Validation Plan, Test Plan, Test Cases, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ)/User Acceptance Testing (UAT), Traceability Matrix, Validation Summary Report, Roadmap of post go live plan, Support plan etc.