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PRISYM Medica software - developed to comply with the FDA's requirements
PRISYM Medica labeling software is purpose designed medical labeling solution for Life Science organizations specifically developed to help meet the FDA's current 21 CFR Part 11 compliance requirements. PRISYM Medica is supplied as a validated medical 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 medical labeling process within your organization
Meet the FDA and MHRA compliance requirements
Realise 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 barcodes GS1 DataBar, ITF14, EAN, DataMatrix, Code 39, Code 93 and QR codes
Supports all your labeling printers (over 500 printer families) including thermal transfer, inkjet and industrial laser printers -- click here for supported Printers
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
Download
PRISYM Medica Data Sheet (204.83 kB)
How PRISYM Medica works with Oracle (490.99 kB)
Pharmaceutical Serialisation White Paper (775.62 kB)
Discuss
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ePedigree and Serialization
Contact
For pricing and other details please contact our PRISYM ID sales team. To discuss our Life Sciences Solutions, please visit our Life Sciences blog
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