fbpx
spk-logo-tm-2023
0%
1-888-310-4540 (main) / 1-888-707-6150 (support) info@spkaa.com
Select Page

PLM in the Cloud: Computer System Validation in FDA Regulated Industries

windchill features best plm software
Written by Mike Solinap
Published on July 29, 2013

Product lifecycle management (PLM) systems have evolved from being custom-built, on-premise applications to cloud-based, off-the-shelf solutions. As adoption for PLM in the cloud increases, system validation approaches in FDA/GXP regulated industries have had to adapt as well.

PLM Evolution

The FDA and Computer System Validation

Computer system validation is mandated by the Quality System regulation (FDA, 21 CFR Part 820) which requires that “when computers or automated data processing systems are used as part of production or the quality system, the manufacturer shall validate computer software for its intended use according to an established protocol.”

Furthermore, computer systems that implement part of a manufacturer’s production processes or quality system are subject to the Electronic Records and Signatures regulation (FDA, 21 CFR Part 11).

The  classical V-Model is typically applied for Software Verification and Validation for enterprise systems:

V-model

Applying the V-Model to Cloud Based Service Models

There are three basic service models in the cloud (source: David Chou, http://blogs.msdn.com/b/dachou/):

Cloud deployment models source - david chou

The V-Model may be applied to systems in the cloud as follows:

v model applied to the cloud

While the IQ, OQ responsibilities are shifted to the cloud service provider, as the regulated company you are still accountable for compliant quality systems. As the regulated company, you must verify that the service provider has appropriate controls in place.

Before you select a cloud service provider for your PLM solution:

  • Conduct  a supplier audit and perform a risk assessment
  • Document risks related to roles and responsibilities, processes controls and technology  used
  • Formally document the responsibilities of the cloud service provider

After going live with cloud based solution continue periodic performing periodic audits of the cloud service provider.

Next Steps:

Latest White Papers

Using AI to transform every team in your organization

Using AI to transform every team in your organization

Utilizing AI tools can help your organization achieve more. Discover the benefits of Atlassian Intelligence and Rovo in this downloadable eBook.What You Will Learn Explore the benefits of Atlassian Intelligence, such as: Accelerating productivity Unlocking...

Related Resources

Buyer’s Guide to CAD Engineering Software

Buyer’s Guide to CAD Engineering Software

Choosing a 3D CAD engineering software can be difficult when there are so many different options on the market. This eBook will explore the considerations your company should take before selecting one. What You Will Learn In this eBook, you will discover which...

Enhancing Healthcare Through Medical Device Managed Services

Enhancing Healthcare Through Medical Device Managed Services

Developing potentially life-saving products requires unparalleled performance, security, and compliance. However, as medical technology continues to evolve, so does the complexity of managing the systems that power it. Hospitals and healthcare providers are facing...