Case Studies


Document Review

An international, Fortune 100, medical device company, hired AP Engineering Services to review approximately 525 documents consisting of Equipment Requirement Specifications, Installation Qualification Protocols, and Installation Qualification Reports generated by our client in support of the relocation of laboratory instruments from one of its facilities to another. The review consisted of reviewing the documents in the client's PDM System, providing feedback to the originator if non-compliance is determined (through PDM), and subsequently approving the documents in the PDM system with client participating in the review of the overall process.


Clean Room Qualification & Process Validation

A major player in the contract manufacturing industry secured business with a small medical firm. The goal was to get a new product to market as quickly as possible by creating a manufacturing and production solution enclosed in a clean room environment.

Using our experienced, knowledgeable and proactive project management team, AP Quality & Compliance reviewed the project schedule and determined what gaps needed to be filled.

AP Quality & Compliance  then completely defined the scope of work in terms that all parties understood, allocated resources carefully, and used our in-house expertise and skill efficiently to start the project.

In the end, AP Quality & Compliance provide a wide variety of talent with experience in quality control, procedure writing and reporting, familiarity with IQ, OQ, and PQ protocol, medical quality and process validation, Quality Engineering, and Program Management.

Because the end customer was a small medical firm, this project required extra resource, budget, and timeline flexibility. AP Quality & Compliance also worked out an arrangement to provide additional cost rates to better match the project requirements.


Packing Validation

AP Engineering Services was hired by a major device manufacturer to produce Packaging Validation according to ISO 11607. The client did not have the necessary resources available to carry out the project and AP Quality & Compliance was able to quickly transition a team of resources to successfully complete the project.  

Our Approach:

  • Organize and execute ISO 11607 shelf-life testing program for sterile medical devices
  • Develop aging/conditioning parameters, packaging test protocols and product performance protocols
  • Develop facility/storage plan to support the packaging/product testing components
  • Coordinate with manufacturing ramp-up planning efforts
  • Make/Buy: Assess potential to condition, store and test components in-house vs. externally
  • Develop test schedule
  • Develop resource plan
  • Develop reporting process with Product Development, QA/RA and Manufacturing Management
  • Provide input and review validation documents related to packaging process
  • Develop/execute validation plan for packaging test equipment
  • Review DOE for pouch making process/pouch/tray sealers

Testimonials

 

I have been unfailingly impressed with the level of knowledge, honesty and commitment shown by the AP Quality & Compliance organization. AP Quality & Compliance has consistently provided engineering resources to help my team meet our Quality and Regulatory milestones. I would highly recommend AP Quality & Compliance for any opportunity within the Medical Device Industry.
— Former VP WW Quality & Regulatory, Haemonetics, St. Jude Medical, Covidien