Power of Technology Vendor Documentation in CSA

As the FDA and other regulatory bodies raise the bar for software validation in healthcare and life sciences, computer software assurance (CSA) activities are becoming increasingly critical to implement, not only for the manufacturers, but also their software vendors. The Software as a Service (SaaS) model, although extremely powerful as a solution, introduces new hurdles for change, maintenance, and release management among other things. Without a sound software development lifecycle (SDLC) and validation practice, choosing a great SaaS solution without a strong vendor is like flying on a private jet without a pilot. Selecting the right software vendor and service provider is paramount for any system implementation to get off the ground.

Identifying the importance of CSA compliance for both software vendors and service providers, Compliance Group Inc has developed a best-in-class vendor selection and qualification process, with a unique emphasis on digital quality. Working with CG, you can feel confident that your SaaS systems are built on a foundation of reliability, security, and quality. In this blog, we will walk through the process of selecting and qualifying a software and service vendor for CSA.

Maximizing the Value of Vendor Documentation in CSA Implementation

CSA is “a risk-based approach for establishing and maintaining confidence that software is fit for its intended use,” according to an FDA guidance report, Computer Software Assurance for Production and Quality System Software.

Upon onboarding a new SaaS solution, vendors should be vetted to determine the robustness of their quality system, the quality and integrity of their software security, and the strength of their validation documentation. A supplier audit or other forms of assessment enable companies to determine whether they will be able to qualify the vendor and thereby leverage the vendor’s systems, services, and/or validation deliverables. CSA is all about making that partnership work.

The regulated company shall ensure that they understand the functionality delivered by the SaaS solution. Software vendors frequently offer manufacturers access to validation documentation, which means that companies can avoid repeating tests already carried out by the vendor, especially on requirements that are met with out-of-the-box functionality. Critical thinking should guide the strategic use of vendor processes and documentation.

Vendors can provide evidence that demonstrates appropriate controls are in place, from formal quality systems through evidence of how they ensure the confidentiality, integrity, and availability of systems.

Expertise in Regulatory Standards

CG brings deep expertise in infrastructure controls and regulatory standards such as FDA guidelines, ISO standards, and GxP (Good Practice) requirements. Our team is well-versed in these regulations, ensuring that Life Sciences technology vendors comply with all necessary guidelines. Our expertise helps mitigate risks and ensures SaaS solutions are reliable and compliant.

Conclusion

By focusing on the critical thinking needed to manage risks during all phases—design, development, testing, build generation, build release, and maintenance—CG provides the right level of assurance and documentation to satisfy FDA requirements.

CG offers clients a best-in-class software supplier qualification process. By scrutinizing vendor documentation, we verify the accuracy and completeness of compliance documentation, certifications, and assurances provided by vendors.

Are you prepared to harness vendor documentation to enhance your SDLC and streamline your path to regulatory compliance? At Compliance Group Inc., we bring deep expertise, proven processes, and innovative technology to help Life Sciences companies reduce risk, accelerate innovation, and achieve quality excellence. Whether you're looking for support with Supplier Qualification, Digital Transformation, or implementing CSA best practices, our team is here to guide you every step of the way.

Let’s simplify compliance and elevate quality—together. Contact us at info@complianceg.com to explore tailored solutions that fit your unique needs.

Compliance Group Inc. – Where Quality Meets Innovation.