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

The Centre for Business Intelligence’s 4th Clinical Supply Chain Management Conference taking place at the Hyatt Regency Princeton New Jersey today and tomorrow (30th and 31st July) will provide a forum for discussion on a variety of topics including labelling regulatory compliance, shipping requirements, and how to increase efficiency of labelling operations.

Bob Brunk, PrisymID’s West Coast US Sales Manager is travelling to New Jersey to deliver a presentation focusing on the use of a dedicated Label Management Systems such as Prisym Medica and Prisym Medica ClinTrial. Bob will describe how using a dedicated designed for purpose solution can improve the efficiency of any organisation looking to package and label clinical trial supplies and comply with regulations such as 21 CFR Part 11.

Prisym Medica and Prisym Medica ClinTrial enables many of the worlds largest Clinical Trials outsourcing companies to operate efficiently, and has helped many smaller organisations become more efficient and effective.

Bob will describe some of the advantages that Prisym Medica ClinTrial offers our customers.

• ACCURATE – Through automated version control and Approval Management
• PRECISE – Label designs are easy to create & approve
• COLLABORATIVE – Labels, and Trial Data are centralised and can be access wherever you need it
• FLEXIBLE – Trial data can be randomised or imported
• EFFICIENT – Labels generated at the touch of a button
• COMPLIANT – Everything is audited and secure to 21 CFR Part 11

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

As pressure from generics increases companies are starting to appreciate the value of brand loyalty.  There will always be some consumers that buy on price but for many a name you can trust is still important.  The focus on branding is impacting many of the labeling projects we are seeing.  A requirement for flexibility to include consistent branding elements on the secondary label is now common.   How this is managed across many different manufacturing, packaging and distribution sites is often the tricky bit.  This is where a web based system like PRISYM Medica comes into it’s own.  Imagine being able to share an approved label design with all your branding elements in place with any site in the world instantly within a compliant labeling system.  Only one design studio is necessary rather than label designers at every site.  This along with the lockable label formats in PRISYM means that the branding (along with all the vital, variable information) is easily controlled.

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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