Case Studies

Piramal Healthcare Installs PRISYM Labeling Software for State of the Art Clinical Trials Packaging & Distribution Facility

PRISYM ID delivers FDA 21 CFR Part 11 compliant randomized labeling management solution for Piramal Healthcare

The Situation

As part of a strategic move into the clinical trials space Piramal Healthcare decided to upgrade its Morpeth site in the UK to become a state of the art clinical trials packaging and distribution facility. This move came as a natural extension of the company's pharma manufacturing business and a response to the increase in outsourced clinical trials packaging. With a first class reputation to protect the Morpeth facility had to be leading edge in terms of technology and demonstrate a robust approach to compliance with FDA and EU legislation.

As part of the project a new labeling system had to be installed.

The Challenge

The new labeling system would have to manage clinical study randomized labels for application to individual component lots and also the labels being applied to complete patient kits. A high level of security and traceability was required and compliance with FDA 21 CFR Part 11 as well as EU regulations.

Phase 2 of the project was to integrate the new labeling system with an in-house developed GMP and project tracking system called Trakpack®.

Key objectives for the project were:

• Zero defect labeling – automation and electronic bar-code scanning to eliminate operator/manual inputs
• Automate randomized label management
• 100% compliance with FDA 21 CFR Part 11
• Printing of label sets for compilation of patient packs
• Seamless integration with TrakPack®
• Easy look up for label histories

The Solution

PRISYM ID's specialist life sciences team worked with Piramal to put together a detailed URS (user requirement specification). A solution was then developed based on PRISYM Medica labeling software and clinical trials module, PRISYM ClinTrial which manages the randomization of labels.

PRISYM ID implemented a network labeling solution that will be integrated with Piramal's in-house TrakPack® software in Phase 2 of the project.

Because PRISYM Medica has been purpose designed for FDA regulated environments and PRISYM ClinTrial is an application specific product very little customization was required. This means the system is easily upgraded in the future and the project costs didn't spiral as implementation progressed.

PRISYM Technology & Services

• PRISYM Medica labeling software
• PRISYM ClinTrial module
• Full lifecycle documentation
• Validation services including IQ, OQ and PQ testing
• Custom design to label production and also label design front ends
• Bespoke customer interface

Benefits

Phase 1 of the project is complete and Ian Morgan, Head of Clinical Trials Supplies at Piramal Healthcare has already identified some key benefits;

• The new system gives nominated representatives involved in the trials secure, web based access to specified areas of the system enabling them to confirm receipt of clinical supplies and update the system with treatments administered.
• Using barcodes to verify key stages of manufacture, product release and logistics PRISYM ClinTrial will remove human error and speed up our processes
• The PRISYM/ TrakPack® solution will allow our customers to view real time information on their clinical trials 24/7. This is a real benefit to international customers operating in different time zones. Customers are able to view every stage from label printing, manufacturing and assembly, product release, shipment and receipt of clinical patient kits.
• PRISYM ClinTrial provides a single system for storing, managing and using clinical trials data in the manufacturing, approval and logistics processes. PRISYM ClinTrial means we can achieve data integrity and control at every stage.

QUOTE

"PRISYM ID delivered on time as promised, despite an aggressive timeline, it wasn't just a sales pitch. They managed the project well working closely with our internal team. I would definitely work with them again"

Ian Morgan,
Head of Clinical Trials Supplies
Piramal