{"id":9931,"date":"2021-12-14T10:20:40","date_gmt":"2021-12-14T18:20:40","guid":{"rendered":"https:\/\/www.qad.com\/blog\/?p=9931"},"modified":"2023-02-15T14:22:54","modified_gmt":"2023-02-15T22:22:54","slug":"understanding-fdas-new-approach-to-computer-software-validation","status":"publish","type":"post","link":"https:\/\/www.qad.com\/blog\/2021\/12\/understanding-fdas-new-approach-to-computer-software-validation","title":{"rendered":"Understanding FDA\u2019s New Approach to Computer Software Validation"},"content":{"rendered":"

[vc_row][vc_column][vc_single_image image=”9935″ img_size=”full”][vc_column_text]The term CSV (computer software validation) invokes nightmares and lost sleep for management at medical device, pharmaceutical and biotech manufacturers because it is such an arduous task and a huge cost to the business. But good news is, there\u2019s a new approach \u2013 CSA (computer system assurance) – and its benefits are huge. Let\u2019s break it down.<\/span><\/p>\n

According to a recent <\/span>Axendia research report<\/span><\/a>, only 37% of life sciences companies have implemented or are currently piloting digital transformation technologies. Why is that? It’s often difficult and costly to change existing processes (or upgrade old disconnected systems) that have already been validated and proven to be effective. So, why change something that\u2019s not broken?<\/span><\/p>\n

FDA Validation History<\/span><\/h2>\n

Validation of software systems traces back to the mid-1970s when FDA officials proposed the validation concept to govern the quality of pharmaceutical products. In 1987, the FDA published its first \u201cFDA Guidelines on General Principles of Process Validation\u201d with a focus on documented evidence to provide assurances that a specific process would consistently produce a product that meets predetermined specifications and quality attributes.<\/span><\/p>\n

In its<\/span> General Principles of Software Validation; Final Guidance for Industry and FDA Staff<\/span><\/a> the FDA calls computer system validation the \u201cconfirmation by examination and provision of objective evidence that software specifications conform to user needs and intended uses, and that the particular requirements implemented through software can be consistently fulfilled.\u201d The validation guidelines relate to hardware, software, peripherals, personnel and system documentation and manuals.<\/span><\/p>\n

What is the Difference Between CSV and CSA?<\/span><\/h2>\n

In a recent<\/span> webinar, Francisco Vicenty,\u202fCase for Quality program manager at the U.S. Food and Drug Administration, and Sandy Hedberg, Cloud Assurance QA\/RA manager at USDM Life Sciences, talked about <\/span>the differences and reasons<\/span><\/a> behind this new guidance (expected FY22).<\/span><\/p>\n

If you think of the 80\/20 rule, the current CSV methodology has manufacturers spending 80% of their time documenting and only 20% of their time testing. The FDA wants to flip this so that 80% of a manufacturer’s time is spent on critical thinking and applying the right level of testing to higher-risk activities, while only 20% of their time is spent documenting (CSA methodology). This critical thinking should be focused on three questions:\u202f\u00a0<\/span><\/p>\n