ACSYS' compliance optimization process integrates industry best practices with a structured methodology creating an objective assessment capability that has been validated in Fortune 500 life science organizations. Elevating organizational compliance capabilities towards world class performance, our assessment process effectively addresses the following questions:

  1. Are the existing design, clinical and quality systems aligned with our business objectives?
  2. How do we minimize design, clinical and quality process constraints to the development and introduction of new products?
  3. How do we evolve our existing systems into enablers of product development/introduction driving sustained market success?
  4. Are we competitive with current design, clinical and quality system trends and industry leaders?
  5. Where are our greatest areas of opportunity?
  6. What are the recommended improvements?
  7. How do we prioritize the implementation of these improvements?
  8. What are the expected benefits?
ACSYS will become a value added partner to answer all these questions and elevate process capabilities. Design, Clinical and Quality process categories/questions are found below. For more information click on the underlined heading below.

Design Controls

  • How are development plans created, approved and managed?
  • Does the organiztion effectively asses risk and manage critical elements?
  • Are marketing and launch requirements integrated with product design requirements?
  • How does the Quality Plan link to design control requirements?
  • Is there a clearly deined product description and performance requirements?
  • What is the process used for design review?
  • What criteria govern desing verification? How is management informed?
  • How are products validated? What system is used for validation documentation?
  • How effective is product design transfer to Engineering and Operations?
  • Are product design changes clearly documented, reviewed and approved? What is the process used?
  • How is product design information included in the DHF? How effectively is design data integrated into the DHF?
  • Whate criteria and process governs laboratory testing?
  • How closely is product design integrated with process development/manufacturing?.


  • Is there a structured, well-defined process of teh execution of clinical trials?
  • How does the organization establish contracts and manage the comunication with CRO's?
  • How are subject records reviewed, analyzed, documented and transferred?
  • What is the organizational method for reporting adverse effects by monitors and interaction with IRB/FDA if necessary?
  • How do IRB's interact with the clinical operations process and what influence do they have in clinical trials?
  • How are protocols developed, implemented and managed?
  • What is the process for managing clinical data? How is clinical data collected, analyzed and reported? Is a common technical document used?
  • How is clinical information transferred to IDE, 510k and PMA for submissions? What is the format of the data?
  • How are clinical results transferred to the sponsor?
  • How is clinical inventory managed through the clinical trial process?

  • How does the organization justify, document and track change?
  • What systems are in place to receive and manage complaints? How is this system tied to failure investigation?
  • How does the organization manage failure investigations?
  • How are corrective actions implemented and their effectiveness measured?
  • How are validation requirements managed, from product design through production?
  • How is product quality monitored, trends identified and improvements implemented?
  • How are internal audits managed (procedures, schedule, resources, reporting)?
  • What are the systems, methods and measures used to manage suppliers?
  • How does the organization manage protocols for risk analysis and design transfer to ensure functionality, safety and reliability?

© 2009 ACSYS, Inc