Case Studies

Specials (SCM Pharma) Implement PRISYM Medica Label Management Software

New labeling system at Specials Clinical Manufacturing delivers increased efficiency and accuracy whilst maintaining compliance with FDA and MHRA regulations.

The Situation

Specials Clinical Manufacturing provides a wide range of manufacturing development and packing services for the clinical trials market. The company initially had no automated system for label management related to their drug labeling or randomized studies and projects for clinical trials. With a growing high profile customer base Specials required a validated label printing system which would satisfy the specific requirements of the Medicines Healthcare Regional Authority (MHRA) and the Food & Drug Agency (FDA).

The solution needed to maintain secure records for clinical trials as well as provide a flexible, easy to use system for labeling patient packs.

The Challenge

Because Specials performs clinical trials and drug labeling, security and regulatory compliance is of paramount importance. A validated system that supports compliance with FDA 21 CFR Part 11 rules regarding electronic records and signatures and also MHRA standards was essential. The system would need to manage the printing of patient data, treatment codes, study centre, stratification group and patient visits, while still ensuring all data is kept secure and traceable.

Key objectives for the project were:

• To maintain MHRA & FDA compliance as part of the label upgrade
• High levels of security, accuracy & efficiency for labeling patient packs
• Tailored to Specials operations including the product & clinical trials databases.
• Flexible, user friendly system for all designated staff which prompts staff for variables to reduce human error

The Solution

Specials deployed industry leading, GMP based label management software from PRISYM ID that includes as standard all the key features required for FDA and MHRA regulated environments. In addition to this a clinical trials module was added from the same software family. Full life cycle documentation was provided with both software products.

Linked to the Specials product and clinical trials databases the new system is able to automate the inclusion of vital variable data in labels. In particular treatment codes, patient visits, study centers and patient data. Prompts ensure that users include the required variables for each label format.

The new system allows specials to automatically record clinical trials and labeling activity in a secure environment. Each record is electronically linked to individual users along with time and date stamping. High levels of security and data encryption ensures systems integrity and regulatory compliance at all times. The system ensures that clinical trials data is accessible and timely.

Once in place the new system was tested and validated by the PRISYM ID project team and user training provided to ensure a smooth 'go live'.

PRISYM Technology & Services

• PRISYM Medica labeling software
• PRISYM ClinTrial module
• Full lifecycle documentation

Benefits

• Ensured compliance
• Improved security
• Improved accuracy
• More efficient record keeping & reporting
• Time and cost savings
• User friendly

Quote

"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"

Elaine Mackie,
Packaging Manager,
Specials Clinical Manufacturing