2013 Trend: Smarter Computer Validation
Having been around when dinosaurs roamed the earth and computer validation was “invented,” I am sorry to say that things haven’t changed that much across the industry. Validation of computer systems was originally expected by regulators and subsequently introduced in the manufacturing (cGMP) and lab systems (GLP) arenas. Clinical departments were loath to adopt validation requirements and, to this day, still seem reluctant to accept these requirements.
Over the years, the “validation community” (QA, IT, business functions, etc.) has been very well intended, with many members attempting to promote the ideas that good software development life cycle (SDLC) practices—including documented testing—made good business sense and we shouldn’t look at computer validation as simply a regulatory requirement. Unfortunately, the validation community as a whole generally failed to get this message across; and to this day, many companies, including many software development organizations within those companies, see validation as a necessary evil to be avoided or minimized at all costs.
Those companies, such as Medidata, who have adopted a more enlightened approach to validation have reaped the benefits of more effective and efficient software development practices and most importantly, higher quality software solutions. In particular, great success has been seen in incorporating validation principles within the SDLC process itself, rather than treating validation as a separate exercise. In addition, more modern development and testing practices, such as those based on the agile methodology, result in higher quality solutions, while still generating the necessary documentation expected by regulators.
In 2013, I see even more companies adopting this smarter approach to computer validation and reaping the benefits of a more effective and efficient validation practice.
More on Fran Nolan
Comments in this post
Leave a reply
- Paper Patient-Reported Outcomes: Golden No More
- mHealth in Clinical Trials: Instrumenting the Patient with Sensors, Wearables and Apps
- Revolutionionizing the Way Physicians Connect Patients to Life-Changing Treatments
- Addressing the Patient Recruitment Challenge in a Disruptive Way
- Risk-Based Monitoring Updates: TransCelerate, the Value of SDV, Global Monitoring Trends and More
By providing study volunteers w ...How Do Medical Device Companies Vie ...
When it comes to risk-based mon ...Revolutionionizing the Way Physicia ...
ePatientFinder makes it possible ...Addressing the Patient Recruitment ...
http://youtu.be/Y_WQ2mGxOqg ePat ...Risk-Based Monitoring Updates: Tra ...
http://youtu.be/_dSiVnjNIyU A ri ...
How Can We Accelerate Innovation with Standardization? Thoughts from the CDISC European Interchange
Kudos! What a neat way of thkiinng about it.
Ni Hao from Shanghai! 上海的你好
Great article. Exciting times ahead. I believe that China will award us the rare opportunity of applying our platform as...
Data Management, Safety Systems and How Technology Can Improve Clinical Development Processes
It is a nice blog. It contain good information on clinical data management
Providing Clarity on the Definitions of Source Data Verification (SDV) and Source Data Review (SDR)
Agreed - a new term would have been preferable, but we of course have the benefit of hindsight. We’re...
Clinical Data Analytics
Clinical Study Design
Clinical Trial Budgeting
Clinical Trial Management
Clinical Trial Phases
Cloud Computing, SaaS and PaaS
ePRO and mHealth
FDA and Regulatory Affairs
Innovation and Entrepreneurship
Interoperability and eClinical
Randomization and Clinical Trial Supply
Site Engagement and Monitoring
Technology and Agile Development