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Transforming Validation: How Validation Can Cost Less, Function More Efficiently, and Add Value to the Enterprise
by EnteGreat

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Paper Overview
For manufacturers in the Life Sciences industry, compliance with regulations from the Food and Drug Administration (FDA) is a fundamental aspect of doing business. A central part of the FDA’s regulatory program is known as validation. Companies producing pharmaceutical drugs, biologic medicines, medical devices, some nutritional products, and certain specialty chemicals are required to provide comprehensive documentation showing that every piece of equipment, every computer system, and every production process consistently works precisely as intended.

The importance of product safety in the Life Sciences industry is indisputable, but it must also be acknowledged that this comes at a price, because regulatory compliance has a tremendous impact on manufacturing costs. In this light, the work of conducting validation is commonly regarded as a distinct and separate activity that primarily increases the cost of production. Thus, validation is viewed as a “cost of compliance.”

This is the shortsighted view, however, because it is possible to make validation a value-added activity. When the right steps are taken to reduce “waste” in the validation process, the cost for validation comes down, but that is only part of the benefit. It is also possible to leverage these changes to improve the product commissioning and production processes. The key here is finding ways to work collaboratively, so that people working in one area can benefit from the efficiencies being created by people in a different area. Coordination of this sort empowers companies to harness the work of validation in ways that truly create new value for the business.

This paper explores the approaches taken by several pharmaceutical companies to make their validation process a value added activity, rather than just another cost. We examine the successful and proven approaches, tools, and methodologies these companies have adopted to help them build this collaborative approach to systems validation and change management.

Paper Outline

• Introduction
• How Validation Works
• Reducing Waste, Increasing Efficiency, and Adding Value
  • Evaluating Risk and Complexity
  • Incorporating Reusability into Design
  • Collaborative Validation
• Best Practices for Transforming Validation
  1. Begin by cataloging all validation procedures currently in use.
  2. Use appropriate tools when analyzing the risk and complexity of each process that needs to be validated.
  3. Examine the validation procedures for activities that do not add value to the enterprise.
  4. Use the ISA-88 standard to incorporate reusability into the design of validation protocols.
  5. Avoid the pitfalls of using validation as a safety net or as a troubleshooting tool.
  6. Include validation in project planning from day one.
• A Summary of the Practical and Financial Benefits
• Conclusion

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