BD is a global medical technology company that focuses on improving drug delivery, enhancing the diagnosis of infectious diseases and cancers, and advancing drug discovery. BD acquired TriPath Imaging, Inc., a global cancer diagnostics company, in 2006.
BD PrepStain Slide Processor Software Application
Create an FDA-compliant software for an automated slide preparation system used in cytology screening.
Quickly assessed the project requirements and implemented an efficient development and validation plan to meet the product release objectives.
Followed FDA regulations and provided guidance on issues related software validation for a Class III medical device premarket clearance.
Established formal software development procedures which facilitated clear, effective communication among teams.
BD received FDA clearance to market the Class III PrepStain system.
“Code Refinery had a good working knowledge of our equipment and instrumentation. They clearly understood our project objectives and gave us a complete solution from software development to documentation and FDA compliance. They were a key member of our team in eventually getting FDA clearance for our Class III device.”
—Senior Scientist, Cervical Programs, BD Diagnostics, TriPath
BioLife Plasma Services
BioLife Plasma Services is a leader in the collection of human plasma for the production of a variety of life-saving and life-sustaining products. These include therapies for hemophilia, immune disorders, trauma, and other life-threatening conditions. BioLife Plasma Services operates numerous plasma-collection centers in communities across the United States.
Upgrade software that operates a plasma screening system.
Migrate a legacy custom instrument software application used to a blood pooling system from Windows NT to Windows XP OS.
Maintain current FDA clearance and minimize impact to screening operations.
Ported the Baxter 3-D blood screening system to the Windows XP operating system.
Centralized software deployment automated post installation steps.
Delivered fully documented and verified system, maintained FDA clearance and kept operational impact to a minimum.
“Thank you for the successful development, validation, and implementation of the ‘Install Software’ for the Baxter 3D Pooling software on Windows XP for the recovered plasma pooling project. The staff at Code Refinery exceeded my expectations as far as the documentation, validation, support, and timeliness of the project.”
— Senior Manager, Regulatory Licensing, BioLife Plasma Services, a subsidiary of Baxter Healthcare
bioMérieux, Inc. specializes in the in-vitro diagnostics sector. They design, develop, produce, and market diagnostic systems for medical and industrial applications.
Provide documentation and software verification & validation for viral detection system.
Document and perform verification testing of instrument software used for a viral meningitis early detection system.
Ensure that development complies with FDA medical device regulations to 510(k) medical device submission.
State of development assessed and recommendations presented to meet program goals.
Development streamlined by utilizing proven design control procedures, version control, and defect management systems.
Final project documentation and development met FDA medical device regulations.
“Code Refinery brings a complete compliance solution prospectively and retrospectively to a client. This includes requirements, specification, verification, and validation along with all of the prerequisite design control documentation and traceability. Their experience helps to efficiently provide the appropriate level of evidence to document that ‘we say what we do and do what we say.’ Code Refinery has established themselves as a solid development partner.”
— Director, Instrument Research and Development, bioMérieux, Inc.
Create necessary 510 (k) documentation for FDA clearance of an in-vitro diagnostic instrument.
Develop FDA 510(k) documentation for software and instrumentation sections of a medical device submission for the NucliSENS EasyQ® Enterovirus instrument
Performed gap analysis between existing documentation against and requirements for a FDA 510(k) medical device submission.
Managed project teams in the US and Europe to coordinate efforts around device 510 (k) for the NucliSENS EasyQ® Enterovirus instrument.
Helped achieve FDA clearance for the NucliSENS EasyQ® Enterovirus instrument.
“We got an official FDA review letter just before Christmas. That letter did not contain a single question on Software and Instrumentation. We asked the FDA reviewer if there would be any more questions regarding the submission. The reviewer said that this was the complete review. So, Code Refinery, many kudos to you!”
—Global Project Management, bioMérieux, Inc.
Develop and execute software verification and validation protocols for the OBSERVA software.
Coordinate and manage verification and validation program and staffing.
Execute software V&V with multiple clinical instrument and software configurations.
Quickly assembled on-site team to create and execute verification test cases.
Performed on-going traceability and risk analysis.
Assumed overall project management responsibility for V&V effort and added additional validation staff.
Met timeline and allowed client to begin the software release process.
“I can only say good things about Code Refinery–the people and the quality of work. Code Refinery has been a critical ally for quite a while now in getting the OBSERVA 3 product to market. I am happy to say, we hope to reach this goal by the end of January 2008. All the members of the Code Refinery Team we have dealt with are consummate professionals with an admirable work ethic. We really appreciate the willingness and ability of the Code Refinery Team to help us in our time of need. I would work with Code Refinery again in the future without hesitation.”
—Staff Project Manager, bioMérieux, Inc.
Mead Johnson Nutrition
Mead Johnson Nutrition provides a wide range of products for adults, infants, and children.
Develop a fully-integrated automated QC system for nutritional products.
Develop a system to test nutritional products to verify product label claims are accurate during shelf life.
Comply with FDA 21 CFR Part 11 regulations and provide electronic records and signatures, data security and integrity, and audit trail capability.
Deliver full documentation and verification and support on-site installation and validation testing.
Developed a integrated system with individual workstations configured through software to meet throughput demands.
Created centrally-located data management that provides secure access by all instruments.
Developed data visualization and analysis tool which allowed final QC results to be uploaded to LIS.
“Code Refinery did a great job. Everyone was very happy with the work that was done and with how easy each one of you was to work with. You have a great team and delivered an exceptional solution!”
— Systems Business Representative, Mead Johnson Nutrition
Tecan is a leading global provider of laboratory instruments and solutions in biopharmaceuticals, forensics, and clinical diagnostics. The company specializes in the development, production, and distribution of instruments and automated workflow solutions for laboratories in the life sciences sector.
Novartis markets products that test for the presence of HIV, HIV-1/HCV, HBV, and West Nile Virus in blood donated to the Red Cross and centers around the world.
Documentation and Verification of Blood Bank Software Application.
Partner with Tecan to create an automated blood pooling system with a customized software application that will integrate easily with Novartis Corporation’s blood bank screening technology and process.
Provide language localization for European and South American markets.
Deliver airtight documentation and software verificationto allow for an FDA 510(k) medical device submission.
Worked closely with Tecan engineers and the Novartis product team to develop a pooling system software application.
Delivered full documentation of development and verification testing.
Helped Novartis achieve FDA 510(k) clearance of CPT Pooling Software application.
“After extensive review of technical support and field reports to find potential issues to resolve with the revision of software, our client did not find a single issue. In the last three plus years of 24/7 usage of the CPT 3.0 software on more than 100 pooling systems worldwide, there has never been a reported bug. Obviously, we, and in particular Code Refinery’s documentation and testing effort, did something extraordinarily right! Code Refinery did a great job.”
—Senior Software Architect, Tecan