Compliance Group is a Life Science industry leader in implementing risk-based Computer System Validation and Computer Software Assurance approaches. If you are interested in FDA’s new Computer Software Assurance draft guidance, read on.
Regulatory guidance on Computer System Validation (CSV) has remained mostly unchanged for the past two decades. Technology, on the other hand, has changed significantly with cloud first architectures and broad adoption of 21 CFR Part 11 compliant solutions. The FDA is bridging this gap between regulation and technology through its upcoming guidance “Computer Software Assurance for Manufacturing, Operations, and Quality System Software”.
Due to the gap between regulation and technology, CSV has morphed into an activity that is done primarily to secure evidence for auditors, rather than to assure the quality of systems. CSA shifts the focus from documentation to critical thinking and testing. While CSV supports risk-based approaches, the focus is often on risk assessment as a documentation exercise. In CSA, the focus is on using patient-centric risk based approaches to drive testing. Download our white paper “Everything about FDA's New Computer Software Assurance draft guidance” for more information.
Burdensome, documentation heavy CSV approaches have been a deterrent to faster technology adoption in Life Sciences industry. CSA truly walks the walk of risk based computer system validation. It advocates leveraging documentation from trusted vendors, reducing documentation burden and viewing technology as a risk reducing enabler.
As one of the founding members of the FDA – Industry CSA team, Compliance Group has successfully shifted numerous clients from burdensome CSV approaches to CSA. Contact us for a free consultation.
This new draft guidance to support risk-based computer software assurance is in the FDA’s “A-List” of guidance documents that the Agency intends to publish during FY2020 (i.e. before September 30th, 2020). However, due to the ongoing international COVID crisis, this release may be delayed. Regardless, the FDA is encouraging the industry to NOT wait for its release, because it is going to be a non- binding “guidance” anyway – that is why many life sciences companies have already adopted this approach.
Furthermore, ISPE GAMP formally endorsed this risk based validation approach in 2019.
CSA process can be adopted using manual, paper based templates or automated paperless validation tools like Siemens Polarion . Compliance Group has deployed CSA at numerous clients using both approaches i.e. paper based computer software assurance templates and automated using industry leading paperless validation ALM tool Siemens Polarion . See our Engagement Models page for engaging our resources to assist with paper based CSA process deployment.
Automation using Siemens Polarion results in an average savings of $200,000 per year for sites with more than 10 GxP systems.Schedule a free Siemens Polarion demo for seeing paperless and contactless Computer Software Assurance in action. Your CSA process can be up and running on our SOC 2 Type 2 certified Siemens Polarion CSA in as little as 3 weeks.
Compliance Group has assisted numerous clients in moving from CSV to CSA. Here’s a snapshot of Compliance Group’s track record
Clients shifted from CSV to CSA
systems “assured” using CSA
pages of needless documentation eliminated
system defects found
average reduction in test script errors
Inspections from 5 regulatory / notified bodies (FDA, MHRA, MDSAP, Health Canada & TGA) supported
See our Why Us page to understand why many client consider us as their partners.
“We needed help increasing the robustness of our quality system and aligning it with contemporary expectations. The Compliance Group partnered with us quickly and surprised us with improvements that were better than we expected. Now our QMS is not only compliant, but it’s lean, too. Win! These guys are experts and they’re great to work with. Highly recommended, they’re one of our go to partners!”
Director of Engineering Services, Gore Medical
“Compliance Group not only remediated 60+ GxP software systems in less than a year, their experts also streamlined our burdensome CSV procedures and shifted us to CSA templates. We had a successful follow-up MDSAP audit and continue to leverage their expert services. Highly recommend!”
Head of CSV, ICU Medical
“Compliance Group provided expert services to help me create a mature set of IT policies and procedures. Their involvement in the FDA – Industry CSA team enabled trust and allowed for early adoption of the FDA’s Computer Software Assurance draft guidance coupled with effective partnering with manufacturing, validation and quality teams. They are highly recommended”
Director of IT, Vericel
Compliance Group has produced the most comprehensive set of insights on risk based computer system validation approaches and more specifically FDA’s Computer Software Assurance. These resources include 10+ webinars, 10+ live industry events and several presentations and white papers. Many of these industry events, webinars were delivered in collaboration with the FDA, ISPE GAMP, FDA-Industry CSA team and Compliance Group customers.
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