LEAN QUALITY^® BY VALIDERA

Manufacturers today are demanding greater efficiencies. At the same time, requirements are increasing from regulatory authorities, particularly regarding automated processes and the handling of electronic production data. As such, there is more pressure than ever before on time and monetary resources.

Cost and time savings are achieved by focusing resources where they are most needed in order to minimize risk, maintain quality and to meet regulatory requirements. As such, our essential tasks are to:

• Evaluate which activities need to be conducted
• Suggest improvements to the validation process
• Know the extent of validation activities required to comply with regulations

Our Lean Quality concept is based on GAMP^®5. Therefore, we place particular emphasis on the following drivers:

• Avoiding duplication of activities
• Leveraging the use of supplier activities
• Scaling all life cycle activities and associated documentation according to risk, complexity and novelty
• Recognizing that most computerized systems are now based on configurable packages
• Acknowledging that traditional linear or waterfall development models are not the most appropriate in all cases