Regulatory Products and Product Validation

Product Validation
Off-the-shelf commercial software solutions are important elements of manufacturing, quality and clinical systems for most companies in the pharmaceutical, medical device, and biotechnology industries. Arbour Group can offer you specific regulatory products and product validation services for your life sciences company.

These applications are governed by U.S. regulations (e.g., GMP, GLP and CFR Part 11) and other requirements and guidelines (e.g., GAMP, MHRA and TGA). To ensure regulatory compliance and reduce business risk, commercial business applications need to be stringently validated. Failure to comply can lead to regulatory roadblocks and a costly loss of business.

Further, the anticipated benefits derived from commercial solutions cannot be realized until those solutions are fully validated. It follows that the expected return on investment is dependent on the validation process.

Validation Product Package
Arbour Group's validation product package includes: +

Validation Benefits
The primary benefits are two fold: +


Product Availability
  • SAP
    The leading commercial business software now has a pre-packaged validation solution for the life sciences industries.
  • Oracle E-Business Suite
    Complementary Service Offerings: Arbour Group supplements the validation product solution with a full complement of Governance.

  • J.D. Edwards
    Whether you are installing JD Edwards Enterprise One for the first time, converting from a legacy system or applying a patch.

  • Argus
    Arbour Group provides updates when patches and support packages are delivered by Argus as well as when regulations change.

  • LIMS
    [Laboratory Information Management] Laboratory systems and software are strategic to life sciences companies.

  • QAD
    QAD compliance is assured by Arbour Group's prepackaged validation product: a field proved, expedient approach.

  • BPCS
    Arbour Group validates BPCS in all forms: patch applications, legacy system conversions, and first installations.

  • Agile PLM
    The leading product life cycle management software now has a pre-packaged validation solution for the life sciences industries.

  • ARISg
    An alternative to manual validation efforts, Arbour Group's ready off-the-shelf validation package is ready for implementation.

  • Oracle CRM on Demand
    Arbour Group's hosted Oracle CRM on Demand validation solution allows you the flexibility of a software subscription model.

  • VMware
    The VMware validation solution is based on Arbour Group's extensive industry knowledge and expertise.


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