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SAP's Preconfigured Systems Speed Up Implementation for Pharmaceutical Industry

Strategic Insights

— 2 min read

SAP's reputation for lengthy implementation and validation processes is being challenged by a firm in suburban Philadelphia that has created preconfigured systems to accelerate the process. The pharmaceutical solution architect at SAP America, Dr. Joseph Cardarelli, notes that the preconfigured systems integrate the best business practices in the pharmaceutical industry into a package that can be used by clients for training and implementation. This approach offers several benefits, including lower cost, reduced risk, improved quality, and faster validation solutions. Preconfigured systems for the pharmaceutical industry are a relatively new concept, and SAP's solution is designed to provide a streamlined implementation process that can begin in as little as two or three days.

Key Takeaways:

  • The preconfigured system developed by SAP America in partnership with a firm in suburban Philadelphia integrates the best business practices in the pharmaceutical industry into a package that can be used by clients for training and implementation.
  • The preconfigured client contains country-specific attributes of R/3, such as language and currency, along with data on the best pharmaceutical industry practices and accelerated SAP methodology.
  • The implementation process can begin in as little as two or three days, according to Dr. Joseph Cardarelli, pharmaceutical solution architect at SAP America.
  • The company is releasing a new version (4.6) in February, which includes corrections to the previous version (4.0), including the requirement to display the user's full name for electronic signatures as per FDA's electronic signature/records rule (Part 11).
  • The preconfigured system is designed to help pharmaceutical companies comply with FDA regulations and reduce implementation costs.
  • Dr. Cardarelli acknowledged the importance of knowing how FDA's enforcement office would react to a firm using version 4.0 and planning to adopt electronic signatures, referencing the former CDER staffer, Paul Motise, now in the Office of Enforcement.

Statistics:

  • Two to three days: The time frame for the implementation process of the preconfigured systems.
  • 4.0: The current version of the preconfigured system, which contains an omission that is corrected in the 4.6 version.
  • 4.6: The upcoming version of the preconfigured system, scheduled for release in February.
  • 11: The part of the FDA's electronic signature/records rule (Part 11) that requires the user's full name to be displayed for an electronic signature.

Sources:

  • Dr. Joseph Cardarelli, Ph.D., pharmaceutical solution architect, with SAP America, Newtown Square, PA.
  • SAP software integrates a firm's business process from supplier to customer into a network of shared information.

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