Blog about Pharmaceuticals – Medical devices – Clinical Trials and Health Care

Lowering the time and cost of computer system validation while ensuring FDA compliance -

Benefits from the Webinar:

• Discover how web-based applications reduce the burden of validation
• Understand how to significantly reduce costs while gaining and maintaining strict compliance with regulations: FDA 21 CFR Part 11, GCP, GMP and Sarbanes-Oxley
• Answer key questions on how the differences between thin and thick client based software can affect your business when designing, producing and managing compliant labels

Full Details….

The Pharmaceutical industry faces challenges in meeting the requirements for serialization coding, challenges
that PRISYMID has been addressing for almost two decades. Our proven, robust and extensively deployed
technology will meet your specific serialization requirements – no matter what manufacturing system, ERP
solution or printing and vision technology you use on your production lines.
‘PRISYM Medica for Oracle’ comprises a full suite of label and code printing applications based on the
Oracle Database and integration for connectivity to your current manufacturing and ERP system.

Serialisation
As new directives and regulations come into force to reduce reimbursement and counterfeit fraud it, is imperative that
organisations can adapt production processes swiftly and efficiently to comply with these regulations.
The latest addition to ‘PRISYM Medica for Oracle’ is the ‘Serialisation Link’ developed to meet the impending
serialisation legislation. Developed in collaboration with Oracle and specifically designed to create very high volumes
of unique, secured and ‘intelligent’ serial numbers. It provides serialised product for industry requirements such
as EFPIA and Turkey and could form the foundation of an ePedigree and EPCIS solution.

• Mass serialised number generation and management
• Serial number relationship and aggregation mapping
• Full cryptographic security
• Full Identity lifecycle Audit management

Get full details by checking this case study from Prisym Life Sciences website

One thing pharma companies are not cutting back on right now is compliance and quality.  A recent survey by compliance specialist Sparta revealed that 80% of quality managers stated their budget had been excluded from cut backs.  (more…)

As part of the ‘GS1 Standards for Healthcare Working Group’ we are encouraged to see so many of the top US healthcare providers supporting adoption dates for the GS1 standards and proactively endorsing the standards to their suppliers.

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Join myself and Martyn Kerluk on 20th February 2009 at 8.30am EST for a webinar on web-based labeling and surrounding FDA compliance issues. Experience the benefits of web-based labeling through a demo of Prisym Medica Web.

On the back of Pharma Packaging and Labeling 2009 we will be hosting a free seminar in Philadelphia and due to popular demand we’ll now be broadcasting this as a webinar too.

Click the link for the full event programme and to register:

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If you are responsible for your company’s labeling system compliance with FDA 21 CFR Part 11, you would have been interested in the recent presentation PRISYM ID made at the Institute of Validation’s week long conference in Philidelphia.  Our presentation ‘Are you really 21 CFR Part 11 Compliant – A DIY Audit’ highlighted the some top areas for non compliance and our own experience of solutions to these issues.

Read on to find out what these areas are and how we’ve overcome them.

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