MasterControl - Quality & Compliance Management PodCast

Accelerating Business Momentum Through Strategic, Risk-Based Technology Validation

February 25, 2019

Technology impacts nearly all aspects of a business and can be highly valuable in planning, making confident decisions, and establishing a fully integrated, quality-driven operation. In most organizations, risk and opportunity analysis has become the norm, and optimizing technology is essential for identifying the best course of action for avoiding risks and maximizing opportunities. Ensuring your technology functions as needed to achieve those objectives is best accomplished through risk-based validation.

To validate technologies, many companies develop some form of process documentation. One highly recommended strategy is to create a master validation master plan (MVMP). This plan consists of key points to consider when dealing with new, revised, and changed technology scenarios. Also, completing aspect and impact analysis for the various technologies in a business can reveal opportunities to advance the organization toward its objectives.

We will examine a model for risk and opportunity analysis for an organization’s validation planning and mapping efforts.

Key takeaways:

  1. Complete a risk and opportunity planning worksheet.
  2. Strategic planning for the various conditions that trigger validation(s).
  3. Map an MVMP for an innovative organization.


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