Case Studies Medical Devices Sabin uses PRISYM MEDICA
Partners
Sabin Injects Validated PRISYM Software Into Its Medical Device Manufacturing |
 |
 |
 |
PRISYM Medica software ensures efficiency and regulatory compliance for medical device labelingPart of the Cook Group, Sabin Corporation manufactures preformed plastic tubing and molded parts to supply the needs of Cook as well as producing materials for the electronic appliance and computer industry.
Sabin needed to install a new labeling system that integrated with the Cook database and centralized control and management of label design and production. The new labeling system would be used to design and print variable data labels in-house for its range of needles. Each label needed to be printed with an image of the needle, a barcode, a product number and expiration date. The ChallengeBeing in the U.S medical device industry Sabin's new labeling system would have to comply with the FDA 21 CFR Part 11 rules. The new system would have to provide secure electronic, signature linked records of all design, approval and production activity and have a high level of access and file security. The selected supplier needed to demonstrate a high level of expertise in providing 21 CFR Part 11 compliant solutions and have the experience and ability to validate the system once in situ. The SolutionThe new system was based on PRISYM Medica labeling software, the world's only purpose designed labeling software for FDA regulated environments. PRISYM ID set up secure links to the Cook database and customized the front end to suit Sabin's operational requirements. PRISYM ID also carried out validation of the complete system. PRISYM Technology & Services The Benefits The new PRISYM system has delivered the vital outcomes required by Sabin: Scott Ridge, Project Manager at Sabin Corporation, commented about his experience with PRISYM ID:
|
For more information, 
