PRISYM PharmaceuticalYour Complete Solution for Pharmaceutical Label Management withLifecycle Documentation

Meeting Pharmaceutical Labeling Requirements

If you are in the pharmaceutical industry, you are well aware of the strict regulations that manufacturers and distributors must meet in order to supply medical products safely, effectively and securely. Following labeling best practices and lifecycle documentation processes is a big part of the compliance process.

Pharmaceutical companies commit a signifi cant amount of time and energy to managing product labeling and the GMP (Good Manufacturing Process) based Quality Management Processes associated with this. Use of computer systems as part of the design, review, and print processes are now common place and in order to meet the FDA and EU compliance requirements relating to computer system validation, companies are investing signifi cant additional resources to produce validation documents for these processes.

How your organization meets these regulations is a huge decision. To achieve and maintain regulatory compliance, many organizations have implemented human intensive practices to manage the processes of designing and approving labels for use, managing the data associated to the product, controlling changes to labels and data, and execution of production label prints. These processes invariably involve paper audit trails, extra label prints specifi cally for the fi le, multiple copies of records and paper record retention. For every stage of the process – whether it’s label design, approval, printing, version control, archiving or record keeping each element must be documented and checked by multiple members of staff. However, no matter how defi ned and well

executed these procedures are and how well your staff is trained; manual processes tend to fall victim to human error. In addition, as organizations grow and need to expand their footprint on a regional, if not a global scale, implementing manual processes becomes unmanageable and expensive.

How PRISYM ID Can Help?

For companies that manufacture and distribute products under the guidelines of organizations such as the FDA, EU and their international counterparts, fi nding an organization who can guide your company through the minefi eld of regulatory requirements is essential. PRISYM ID’s depth of experience in the life sciences sector, superior labeling software and dedication to service excellence has established us as a world leader in labeling solutions.

The Solution

PRISYM Pharmaceutical is a fully featured, easy-to-use package for designing label templates, creating barcodes and printing your labels in-house. PRISYM Pharmaceutical includes approval and security features to prevent unauthorized users from modifying labels, or printing labels which have not been approved. Different levels of access can be assigned to users, restricted through password controls. In its basic form, there are three levels of security: designer, approver and print-only. An audit trail is generated and records the date and time when a label format is created, deleted, altered or approved - and by whom. A production log is updated every time a print run is requested and, like the audit log, can be imported into other software, such as spreadsheets, for analysis.

Tel: +44 (0) 118 936 4400 | Fax: +44 (0) 118 936 4499 | E-mail: info@prisymid.com | Web: www.prisymid.com©PRISYM ID Limited 2012. All rights reserved. You may not copy, reproduce, transmit, store or modify any of the material in this brochure without prior written permission of PRISYM ID.

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The label design application allows you to reduce the number of label designs by creating templates which include variable data such as product codes descriptions, barcodes, logos and images in your labels. It also provides easy connectivity with ERP or MRP systems to help integrate the labeling function with the rest of the business process. Another piece in the lifecycle documentation process involves tracking all of the relevant data around each print run. With PRISYM Pharmaceutical every piece of relevant data from every print run can be recorded in a print log fi le. Details such as user ID, format name, description, label stock type, printer name, printer location, print quantity plus all the variable names used on the label, along with the values contained within them are automatically recorded every time. This audit log can then be exported in a format usable by spreadsheets and databases for analysis at the click of a button.

PRISYM Pharmaceutical Enables You To:

• Allow only authorized users to create, edit or print labels as well as monitor their activity

• Use one complete labeling system for all your printers (supporting over 500 printer families) including thermal transfer, inkjet and industrial laser printers

• Automatically include a wide range of variable data such as product codes, pricing, additional languages, hazard symbols, warning signs and hazard signs

• Set up frequently-used variable defi nitions once and store it in the global variable library for instant use on new label formats

• Design label templates to produce labels for global use due to Unicode compliance

• The ability to lock down a label format so that it cannot be amended once it goes into a production environment

• Create a library of label stationery types, specifying label

size, number across the web and other printer specifi c attributes such as head temperature, sensor types and printer speed

• Use non-printing “phantom” fi elds to accommodate pre-printed label stock, perforated stock or peel-out section

Coding Technologies

PRISYM Pharmaceutical includes our best-of-breed code creation software module. It enables you to produce over 35 types of codes including Linear, 2D, GS1 DataBar, TF14, EAN, DataMatrix, Code 39, Code 93 and QR codes.

Unrivalled Support Services

The PRISYM ID team have specialist knowledge to make sure you know the “do’s and don’ts” of Pharmaceutical labelling. PRISYM can be purchased with software maintenance as part of the solution to make sure you have full peace of mind.

We offer software support services that will seamlessly manage your company’s needs from troubleshooting to upgrades, re-installation, and confi gurations.

• Support hotline

• Onsite software support

• SLA levels to suit your requirements

• 24/7 support options

• Onsite customer training

Tel: +44 (0) 118 936 4400 | Fax: +44 (0) 118 936 4499 | E-mail: info@prisymid.com | Web: www.prisymid.com©PRISYM ID Limited 2012. All rights reserved. You may not copy, reproduce, transmit, store or modify any of the material in this brochure without prior written permission of PRISYM ID.

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