TEVA Strengthens Security for Software Assets with MKS Integrity
“One of the main measures for success in the implementation of the MKS Integrity Suite was the reduction in the amount of paper and forms that get manually pushed from person to person. By simply automating service request forms and routing them via electronic workflows we have become much more effective, and dramatically reduced our time spent managing projects.”
Tom Loane, Chief Information Officer , TEVA Pharmaceuticals
TEVA USA is a wholly-owned subsidiary of TEVA Pharmaceutical Industries Ltd., Israel’s largest pharmaceutical manufacturer operating globally in 30 countries on 5 ...view middle of the document...
They must specify intended use and user requirements, of the software; make sure and verify that the software meets the requirements through proper design, implementation and testing and maintain proper use through an on-going performance program. The goal for TEVA is to reduce the burden and cost associated with compliance to FDA regulations. In parallel, TEVA has experienced significant operationalgrowth. With completely manual, paper-based change processes, the organization’s ability to adopt less burdensome and low cost processes was limited. With respect to change controls, the transition from the actual work products implemented, and deployment to production was not a smooth process. As a result, TEVA staff was spending a disproportionate amount of time on change control activity. TEVA’s manual processes also made it difficult for management to conduct root cause analysis, identify potential bottlenecks and anticipate potential problems. The manual Change Control Request Forms (CCRFs) resulted in an inefficient change control process with disconnects to internal reporting systems, reducing management visibility and control over 1 | TEVA USA Case Study
TEVA Pharmaceuticals USA
the status of work in process. This was detrimental to management’s ability to efficiently manage and allocate resources. Inefficient configuration management and security policies around how software assets were versioned further complicated compliance objectives. The problem affected all business critical applications in the distributed clientserver environment (Oracle, LIMS, as well as other Java and HTML based applications). With an ever-increasing rate of change, disconnected tools, and manual processes, the IT organization was challenged to remain efficient and meet compliance requirements. Initial Steps for Compliance TEVA’s IT department identified requirements for a change control process that is more efficient and compliant with Good Manufacturing Processes (GMP). Good Manufacturing Practices are standard guidelines set out by the FDA to ensure drug development is carried out in safe and quality processes, to avoid contamination and ensure repeatability. In support of this compliance effort, TEVA evaluated change and configuration management solutions. Following a thorough evaluation process, MKS Integrity was selected for four primary reasons:
> Customer support – MKS’s team had a
proven track record of providing fast and effective technical support
> Cost – it was determined that MKS’s
solution would provide a lower total cost of ownership when compared to the other solutions Another primary...