Specials Clinical Manufacturing Installs MHRA & FDA Compliant Label Control and Production Solution

PRISYM Medica labelling software combined with PRISYM ClinTrial brings greater efficiency and ensures regulatory compliance for Specials Clinical

Specials Clinical Manufacturing (SCM) provides a wide range of manufacturing development and packing services for the clinical trials market and works with the top 20 pharmaceutical manufacturers. It is business critical that SCM maintains FDA and MHRA compliance and the high levels of security, accuracy and efficiency that their customers demand. SCM were keen to upgrade their labelling systems at their state of the art facility in Northumberland, UK as part of their ongoing commitment to provide the best possible service to their customers and continue to win new business

Challenge:

A validated label printing system which would satisfy the specific requirements of the Medicines Healthcare Regional Authority (MHRA) and the Food & Drug Agency (FDA) was required.

In addition to patient pack labelling the solution needed to incorporate the special requirements of clinical trials labelling including randomisation, treatment codes, study centre, stratification group and patient visits whilst ensuring that all data is kept secure and traceable.

A high security but user friendly system that was tailored to SCM operations was required.

The solution:

PRISYM ID worked with SCM to develop a detailed URS (User Requirement Specification) before implementing a solution based on PRISYM Medica and an additional software module, ClinTrial which handled the clinical trials requirements.

Because PRISYM Medica and ClinTrial are purpose designed software very little customisation was required. This ensured a cost effective and easily upgradeable solution was installed.

In addition PRISYM ID carried out all the IQ, OQ and PQ testing and complete validation of the system.

PRISYM Technology & Services

• PRISYM Medica Labelling Software
• PRISYM ClinTrail Software
• Testing & Validation
• User Training
• Maintenance & Helpdesk Support

The benefits:

The PRISYM solution has delivered several key benefits;

• Compliance confidence
• Secure, traceable records
• Reduced human errors
• Automated variable data
• Improved efficiency

Elaine Mackie, Packaging Manager at Specials Clinical Manufacturing, comments:

Initially, there was no suitable system in place for printing labels, especially labels for randomised studies and projects. We knew, however, what level of quality we required and the PRISYMLS system not only delivered, but exceeded our expectations.

Unlike PRISYMID, 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

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