Regulatory & Compliance

Challenge: Under a Consent Decree related to improvements needed in their Quality System and Medical Device Reporting

Team Size: Delivered a team of over 170 consultants over a period of 5 years

Redbock Solution:

• Chosen as one of two resource solution firms for this project
• Our team reached a maximum of over 60 people working on the project at one point in time
• Scaled the team throughout the project based on need with the ability to deliver anywhere from 2-15 resources on-demand
• The client received notice from the FDA that it had successfully completed its work plan, thus lifting all shipping restrictions imposed as a term of the 2011 Consent Decree
• Deployed team with specialized skill sets including: Computer System Validation Engineers, Process & Production Control Engineers, Manufacturing Engineers, Project Managers, CAPA Engineers, Supplier Quality Engineers, Product Development Engineers, Electrical Engineers, Mechanical Engineers, Training Specialists
• Performed gap analysis
• Performed equipment qualification testing and verification
• Evaluated and Approved TMV Protocols, Reports and Technical Reviews
• Provided authorship and execution in IQ, OQ, PQ, TMV, MVP and Validation Trace Matrices
• Tool & Fixture design Validation
• Performed feasibility & engineering studies
• Generated and executed Attribute and Variable Test Method Validation (TMV) Protocols & Reports
• Performed statistical analysis on validation data for Gage R&R and % tolerance
• Created, maintained, summarized, reviewed, and approved QA related-documentation against quality-document attributes
• Performed Readiness/Auditing Review for existing validation documents to determine compliance with current procedures and regulation
• Internal and external auditing
• Software Quality Assurance review for validation lifecycle documentation for various medical device product families, including: Validation Plan, Change Analysis Form (CAF), Gap Assessments, IQ, OQ, PQ, Periodic Reviews and Summary Reports
• Implemented risk-based System Validation, Process Validation and Test Method Validation
• Developed documentation for the remediation of Production and Process controls for electro-mechanical surgical equipment and instruments to address action items in the FDA Consent Decree Work Plan