HomeIntegrated ComplianceSuccess Stories: How Compliance Group Empowered Clients to Overcome Compliance Hurdles and Achieve Desired Outcomes?

Success Stories: How Compliance Group Empowered Clients to Overcome Compliance Hurdles and Achieve Desired Outcomes?

regulatory-compliance

The journey of regulatory compliance often presents challenges for organizations across Lifesciences industries. However, navigating these hurdles and achieving desired outcomes is not only possible, but can be transformative with the right guidance and expertise. In this blog, we delve into real-world examples of how Compliance Group Inc. (CG) has empowered clients to overcome compliance hurdles and achieve objectives. Through these stories, we'll explore the strategies, solutions, and collaborative efforts that have led to success, offering valuable insights for organizations seeking to navigate the complex landscape of regulatory compliance.

A great example is the Health division of US-based multinational diversified manufacturing company. It is a $30B+ contract manufacturer, with a $6B Health division. As the company provides product development and turn-key manufacturing services for many different Medical Device and Diagnostics OEMs, it is critical that they validate software in a compliant and efficient manner, especially because Computer System Validation (CSV) is an FDA (Food and Drug Administration) regulation. Traditionally, many Lifesciences companies use heavily scripted/documented approaches, which are error prone, inefficient, and create significant non value-added work. These approaches may potentially miss unknown critical requirements that need to be tested.

The manufacturing company collaborated with CG to implement a robust risk-based Computer Software Assurance (CSA) business process, so they could test smarter, while significantly reducing time and documentation required. After demonstrating significant value with a manual process, they invested and adopted a Digital CSA process, using the Siemens Polarion technology, implemented by CG. With a digital data centric CSA solution, the company significantly increased the velocity of change, while error proofing their validation activity. They were able to visualize the ‘end to end’ digital threads of their impact analysis.

Their Global VP of Quality presented numerous quantitative and qualitative value metrics during a public webinar hosted in collaboration with CG, on February 20th, 2024.

The webinar recording and presentation can be accessed by visiting this link: https://www.complianceg.com/compliance-webinars/digital-csa-industry-4-0/

Another client example is a US-based pharmaceutical company pioneering drugs and gene therapies for patients with rare and serious diseases, like Duchenne Muscular Dystrophy and Spinal Muscular Atrophy.

Given the risks associated with pharmaceutical products, there is a need for product quality to be the driving force of projects, as opposed to being an afterthought or a downstream process. With this approach, Compliance Group supported the pharma company as a strategic partner in all three arenas of its regulated Software Quality and Compliance domain:

  • People: CG’s expert Life Sciences Software Quality resources ensured regulated enterprise software systems were developed, validated, and deployed per company processes and federal regulations.
  • Process: As a pioneer in developing and deploying the latest FDA guidance on Computer Software Assurance (CSA) with 30+ Life Sciences clients, CG upgraded the company’s Software Validation processes to adopt this latest guidance.
  • Technology: True benefits are realized when processes are digitalized. For the pharmaceutical company, CG developed, hosted, and deployed a Siemens Polarion Digital CSA solution. This solution not only digitizes CSA processes, but also provides a data-centric approach to facilitate re-use, develop insights, and drive continuous improvements. Full adoption of the tool is planned for late 2024.