Design Control Process Optimization

Health science organizations must readily adapt new practices, employ enabling technologies and, most importantly, provide education and training to employees on the latest industry trends to remain competitive. Being ahead of the curve is a critical success factor often in conflict with demands to rapidly develop and introduce new products. ACSYS' innovative process for assessing the Design Control process capabilities is a valuable tool for optimizing design control processes elevating performance to best in class. Developing enabling Design Control capabilities supportive of market growth while meeting Regulatory Compliance requirements is a challenge for even the best organizations.
Our assessment approach includes valuable benchmarking and quantification of best practices. This information is integrated into the assement process which includes data collection from all organizational layers and peer/customer groups to collect performance data. The data collected is analyzed and used to develop actionable recommendations for elevating Design Control capabilities to world class.
A graphical representation of Design Control process data (sample below) effectively highlights areas of strength and opportunities for improvement. The objective scoring methodology used to analyze data collected is a key foundational element to providing value added recommendations driving Design Control process improvement. Typical assessment areas for Design Control processes are shown below. A sample scoring chart shown below provides a visual representation of process capabilities.
 Typical Assessment Categories
  1. Design and Development Plan
  2. Product Risk Assessment
  3. Product Strategy and Planning
  4. Quality Plan
  5. Product Requirements/Description
  6. Design Review/Verification
  7. Product Validation
  8. Design Transfer
  9. Design Change Control/History File
  10. Animal Testing/Lab Practices
  11. Process Development
Design Control Process Scoring


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