PRISYM Medica is a purpose designed labeling software solution for Life Science organizations specifically developed to meet the FDA’s current 21 CFR Part 11 compliance requirements. PRISYM Medica is supplied as a validated labeling solution including auditable security protocols and lifecycle documentation based on the GAMP V Model.
Available both as a thin or thick client, PRISYM Medica allows you to design, review, approve, print, reprint and reconcile your labels with the peace of mind that it has purpose built user security, group security and secure audit logging. It can also simply link to ERP and MRP systems to ensure that information from production can be delivered to the label at time of print.
PRISYM Medica enables you to:
- Implement one complete solution to fulfil the labelling process within your organization
- Meet the FDA and MHRA compliance requirements
- Realize GMP compliance by meeting the GMP’s guidelines
- Ensure complete history is maintained though the system by automatic revision and version control
- Build a three stage approval mechanism, reducing the opportunity for error to be present on label used in production
- Reduce duplication and easier to manage label designs with data driven printing
- Design labels for global use due to Unicode compliance
- Produce over 35 types of bar codes including GS1 DataBar, ITF14, EAN, DataMatrix, Code 39, Code 93 and QR codes
In addition, our thin client PRISYM Medica Web offers you:
- An Internet Explorer based solution which is quick to deploy and can be used ‘outside’ the organization for selected partners
- The ability for less validation effort than traditional thick client solutions, enabling faster rollout
- A proactive review and approval work engine which increases the accuracy of layout and data used on labels reducing the likelihood of product recalls
