ERP Validation

With 15 years experience, Business & Decision specializes in the computer system validation of ERP systems such as SAP, Oracle (E-Business Suite and JDEdwards) and Microsoft Dynamics.

ERP Validation Leaders

Business & Decision were applying the principles of risk-based validation to ERP systems as early as 1996 and since that time have established a long track record of validating ERP systems from all of the major software vendors - SAP, Oracle and Microsoft (with whom Business & Decision has significant partnerships) - as well as many other ERP vendors.

Our clients range from top ten pharmaceutical and medical devices companies for whom we have provided consulting teams to lead and support world-wide ERP programs to small single site medical device and biotechnology companies implementing their first ERP systems.

Our ERP validation services fall into two main categories:

• Strategic consulting, during the implementation and planning stage of projects

• Validation services, throughout the project and operational phases of the ERP life cycle

Leveraging an in-depth knowledge of ERP implementation and support best practices from our software partners, B&D has succesfully supported clients through many different types of ERP validation project including:

• Prospective validation of new implementations, including implementation by Business & Decision or other system integrators

• Retrospective validation, required either as a result of a change in use or because or reguatory compliance issues

• Revalidation, as a result of a merger, acquisition or divestiture or a significant change in use

• Ongoing periodic review and validation support throughout the operational phase of the ERP life cycle

While Business & Decision remains engaged in a number of service delivery engagements, its current strategic focus is on applying the Key Concepts of GAMP® 5 to the validation of SAP, Oracle and Microsoft ERP systems, working with its own ERP Divisions, other system integrators or directly with Regulated Companies. B&D also specializes in helping companies to address ERP validation and compliance challenges arising as result of organization change (internal or as a result of aquisition or merger) or regulatory inspection observations.

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