Publish date July 17, 2017
It is no secret that the life science industry is always challenged globally by ever evolving stringent regulations. With the modernization of the life science industries, implementation of technology has increased. To prevent software malfunctioning and more importantly to ensure that the life science technologies are safe for patients, CSV is mandatory for all life science companies.
Life science industry includes pharmaceutical, biotechnology, Clinical Services, and medical device manufacturing companies. The products/services of these industries need to maintain a set of attributes that includes safety, identity, strength, quality, purity, and efficacy.
Validation is establishing documented evidence providing a high degree of assurance that a particular computerized operation or process will consistently produce a quality result meeting its predetermined specifications. The data and processes involved have a direct impact on product attributes (mentioned above), which can be critical in nature being linked with Human wellbeing.
Validation is all about objective evidence, and the system performs as per pre-defined requirements. From our experience, we have found some gaps commonly found in validation, which is listed below:
Common Validation Gaps
A typical CSV SDLC process includes six steps as follows:
21 CFR Part11 compliance is obligatory for all electronic records and signatures, which in turn ensures that the system generates accurate records and time-stamped audit trails.
Any qualified vendor would guarantee that a gap analysis report is generated after system assessment. Next 21 CFR part11 remediation plan is created that addresses the hardware and software requirements aligning to CSV policies, procedures, and training plan. In addition to this, during development, the system is remediated for all 21 CFR Part 11 requirements. Once the system is compliant with 21 CFR, the validated state is maintained.
Validation is a never-ending activity and system has to be maintained in a continuous validated state. Change is the only constant. New improved technologies are popping up now and then even in the life science industry. This leads to the next question:
How To Implement Changes In A Validated System Without Compromising The Validated State?
After the system is in a validated state any change to production environment can be made via a risk-based change control process. There are five stages in the workflow as mentioned below:
Computer system validation is an important tool to assure quality of computer system performance. CSV enhances the reliability of system, resulting in fewer errors and less risk to process and data integrity. It also reduces long term system cost by reducing the cost of maintenance and rework.
For more information and a demo on Computer System Validation. Watch On Demand Webinar
Ramakrishnan Balasubramanian Program Manager – Life Sciences Practices@ YASH Technologies