Pharmaceutical CRM


Customer Relationship Management (CRM) systems have been used within the pharmaceutical domain for more than two decades, undergoing a metamorphosis along the way. The transition in marketing strategies of life sciences companies from targeting primarily medical practitioners to the intensive multidimensional marketing campaigns backed by larger specialized sales forces and multimedia seen today drove the CRM transformation. While the first deployments of CRM comprised simple stand-alone sales force automation packages deployed with early adopted laptop technology, CRM’s have become integrated portals  supporting the multiple roles undertaken by field representatives as organizational structures have been consolidated.

From a compliance perspective, the impact of these new CRM roles encompasses what was formally the domain of more specialized transaction oriented systems. These often comprise creating product orders, tracking  product delivery, utilization and returns,  sample inventory management, collection of customer complaints and even adverse event reporting. While the CRM often acts as the front end data capture mechanism feeding more traditional corporate systems such as ERP, AE, PLM and Customer Complaint systems, the CRM inherits the compliance requirements associated with the business process it is suddenly facilitating (e.g. traceability, security, Part 11 etc). 

To compound the problem, the extension of legacy unvalidated CRM platform roles often occurs outside the purview of Quality Assurance, and companies are often unaware of the new risk profiles being created as the CRM is enhanced to fulfill these new missions.

The trend to outsource the expanded CRM platform to hosted environments or SaaS based services creates additional complications for compliance as the qualification status of the outsourced platform is often not fully assessed.

USDM has experience anticipating the implications and meeting the challenges of the transformation of CRM from a dedicated sales and customer communication tool to regulated corporate transaction portal.



  • Clintrak - Jeffrey D. Coffin
    I have had the great pleasure to work with Bob for 5 years in his position of VP of Quality at Fisher Packaging Services while I acted as Director of Quality services at a sister…
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