Marc White, Systems Project Manager for Boston Scientific:
"It was pretty obvious from the beginning that PRISYM ID have a very strong grasp on software validation and the implications of FDA 21 CFR Part 11. PRISYM ID has provided us with a labelling backbone integrated to our other enterprise systems and our product database."
 

Elaine Mackie, Packaging Manager at Specials Clinical Manufacturing:
"We knew what level of quality we required and the PRISYM system not only delivered, but exceeded our expectations. Unlike PRISYM, many of the other systems we considered did not provide the correct level of service and security, which is an especially important factor in our industry. Plus, the PRISYM Medica software is user-friendly and has a very useful reminder mechanism."
 

Scott Ridge, Project Manager at Sabin Corporation:
"Our parent company Cook is already using the PRISYM Medica software, therefore, we were aware of its capabilities, reliability and compliance with FDA regulations. Using the same system also meant were could centralize the process. Security and regulatory compliance is of paramount importance in medical device manufacturing.

Prisym Medica is able to provide us with the correct level of service and security we require, whilst being user-friendly. The install of the system into our clean room went smoothly and we have been pleased with the results."
 

Vincent Santa Maria, President Bilcare Global Clinical Supplies, America:
"The installation of PRISYM label software is the latest step in our ongoing effort to continually improve the quality of service we offer our customers,"
 

Jean-Claude Muller, Director of Global Supply Chain Support at Merial and Chairperson of the Global Traceability Core Team of the IFAH:
"With more than 4000 different pharmaceutical and biological products, we needed a system that could be compliant with all possible pharmaceutical regulations worldwide. PRISYM Medica was the only software we found that was able to be validated for the FDA�s CFR21 Part 11 regulations. Taking a leading position in the traceability initiative agreed by the IFAH, we worked closely with PRISYM^ID to develop the 2D Datamatrix ECC200 feature.

The project has been extremely successful and the system has now been tested and validated with PRISYM^ID's support,"
 

Kevin Hawkins, Technical Analyst, Baxter:
"It was critical that we had a labeling system that complied with the strict requirements of the FDA, especially 21CFR Part 11 rules. Because of the nature of our business, security is an overriding requirement in our service delivery. PRISYM Medica allows us to limit access to the database, to limit the programs that can be opened by individuals and also to ensure that once approved nothing can be changed without our Quality Assurance people being involved.

The extended hours Software Support Agreement is also an important benefit for 24/7 production.

PRISYM Medica has been an unqualified success, so much so that we are planning to roll it out to three other lines in the near future."