Veeva expands into quality management systems

Continuing on its path of all-cloud software for all things IT in life sciences, Veeva Systems is now addressing the quality management function. The company’s first step, years ago, was the creation of the Vault platform, a cloud-based system to organize regulated documents. That led fairly quickly to QualityDocs, a Vault application specifically for storing, retrieving and tracking quality-management documentation. Now, with Vault QMS, the company is addressing the process-oriented aspects of a QMS—developing and following quality control steps, corrective actions, and auditing processes.

Mike Jovanis, VP for Vault Quality, says that there are three key benefits to the Veeva offering:

• Process steps have been organized according to best practices, as determined by interactions with key clients to synthesize “what’s out there today” in common industry practices.
• The cloud-based platform expedites unifying a company’s quality-management processes with those of contractors, trading partners and the like; no “bolt ons, private networks or other custom coding” is necessary, only setting up the access and data exchange process with the clients and suppliers.
• Combined QMS and document management—according to Jovanis, existing quality systems used in industry tend to be either for tracking documents, or for managing quality processes; by combining both on the Vault platform, these interactions are streamlined.

Jovanis notes that quality management originated in, and remains strongly influenced by, the steps necessary in manufacturing (GMP) operations. However, much of the GxP world—good clinical practices (GCPs), good laboratory practices (GLPs), and, more recently, good distribution practices (GDPs), among others—have adopted quality control and assurance processes. In theory, a system like Vault QMS could be used to run all of them; but different operational areas have different specific procedures, but across and within pharma companies. Jovanis says that Vault QMS is easily configured to manage such disparate activities, while noting that the platform will see continual evolution as its customer base grows.