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 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

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…)

There has been an increase in seminars, news articles and general comment on joint FDA and EMEA (European Medicines Agency) inspections recently.  It seems a day doesn’t go by that a guide or webinar invitation doesn’t pop up in my email.  Is it all as scary as it seems?  And how does it affect labelling systems?

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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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