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?.
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- 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?
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- 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?
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