The traditional approach to Computer System Validation (CSV) has been criticized for being burdensome and resulting in excessive paperwork. However, with the upcoming FDA guidance on Computer Software Assurance (CSA), it is time to rethink the CSV approach. CSA is a risk-based approach that focuses on patient safety, product quality, and data integrity. While there is no change to governing regulations or GAMP 5, CSA emphasizes testing critical aspects in an efficient way and avoiding unnecessary bureaucracy.
CSA applies to non-product systems, such as eQMS, eDMS, LMS, LIMS, and ERP systems. Implementing a strong supplier assessment program, using a risk-based approach, having a strong internal change control process, and using automated testing
tools are all ways to reduce unnecessary testing and paperwork. Additionally, using a collaborative approach between the computerized system process owner, the validation team, and Quality Assurance can ensure that the system is validated for its intended use without undue burden.
Overall, the shift towards CSA provides an opportunity to improve the efficiency and effectiveness of computer system validation while remaining compliant with regulatory requirements.
Software validation (CSV) as defined by the FDA is a documented process to demonstrate that computer software works according to its intended design. Computer software assurance (CSA) is a risk-based approach that limits testing to functions directly impacting product quality and patient safety. CSA also encourages companies to use the software vendor’s documentation to reduce the testing burden and deploy applications faster. According to the FDA, software not used in a product (e.g., off-the-shelf production manufacturing software) is not subject to the same rigorous requirements of computer systems validation that have been used in process validation.
Instead, manufacturers can use computer systems assurance to target verification and validation testing for only high-risk activities. The FDA’s Center for Devices and Radiological Health (CDRH) has prioritized guidance on CSA for QMS software for publication in 2021 or 2022. It will provide specific guidelines to define CSA and provide direction for making this transition.
The Challenge of Computer Software Validation Encouraging investment in technology is a priority for the FDA as it acknowledges digital transformation as a catalyst for reducing quality issues and patient risk. Conversely, the agency’s Case for Quality initiative to identify the practices of high performers in the medical device industry, identified software validation as a leading roadblock to technology adoption.
By
Dr. Pari Subash
#FDA #quality #opportunity #opportunity #design #design #CSV #team #technology #qualityassurance #health #medicaldevice #data #manufacturing
No comments:
Post a Comment