At USDM Life Sciences, we routinely observe the underestimation of the regulatory impact on a CRM system due to what appears to be routine integration projects with legacy systems. There is a general lack of awareness that when life sciences companies integrate the CRM system with legacy GxP systems, the CRM system becomes an extension of the regulated system As a result new requirements emerge for the management of the formerly unregulated CRM system, which may include the following components:

  • CRM Platform qualification – hardware and software, which may be remotely hosted
  • Application Validation – Selective based on function, or more comprehensive
  • Change control (platform and application)
  • Quality System documentation (training, document control)

The impact on the management of the CRM system will vary based on the legacy architecture of the CRM:

  • If  it is integrated with an existing legacy validated ERP suite on the same qualified infrastructure  platform, less potential impact
  • If  the CRM is hosted on an in-house but separate internal platform and vendor from the integrated system, it can have a greater impact
  • If the CRM is hosted in a SaaS platform or application vendor, the impact is much greater –Why?

Key Principal: The SaaS or 3rd party hosting platform provider should not be operating at a lower level of GxP compliance than that provided for your internally hosted regulated applications!

The CRM practice is devoted to help clients anticipate the regulatory challenges inherent in moving the CRM system into a more comprehensive roll in the enterprise to reduce the cost of compliance and increase the ROI of IT investment which comes from the convergence of corporate systems. This blog will explore the unique evolving role of the CRM system from sales force automation tool to a field service corporate gateway platform to the global enterprise transactional environment, and general purpose application toolkit.

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