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Sarbanes-Oxley

Life Science Companies have a head start on Sarbanes-Oxley Compliance!

The life science industry is one of compliance. For those employed in the industry, compliance is simply ingrained in their work habits;

…Compliance with the FDA regulations.
…Compliance which ensures all products are manufactured, tested, packaged, labeled, shipped and marketed with accuracy, consistency and reliability.
…Compliance which ensures the integrity of the products and hence the safety of the consumer.

In recent years, the life science industry has been inundated with discussions about, guidance documents issued, industry discussion, final rule, retraction, re-issue (and the list goes on) of the 21 CFR Part 11 Electronic Records, Electronic Signatures document. The issue continues to be bounced around even years after first being presented to industry. And as the industry continues to dissect Part 11, life science companies unwittingly have a head start on complying with the newest beast facing American industry - Sarbanes-Oxley.

In light of the recent, and very public, accounting scandals, Sarbanes-Oxley will be implemented in publicly traded companies to ensure integrity of the business finances and hence protection of the shareholder. These two regulations are not that far different from each other.

…Both are insisting on accountability of information.
…Both require an audit trail.
…Both are in place for the ultimate protection of another party. Obviously the regulations are similar.

Managing any compliance can be addressed with a requirements-based methodology. Break down the regulations into requirements statements and test against them. PENSA has been doing it this way forever.

Consider the $$$ your firm spends on meeting compliance in Computer Software Validation (CSV) and how little you have to show for all that effort and $$$ expense?

This has to include the direct $$$ costs of initial CSV for new systems, the on-going $$$ costs of re-validations, the lost $$$ investments in software, the maintenance ROI that is foregone because legacy systems are not re-validated, the ever increasing budget $$$ for outside consultants, the lost productivity from internal staff, just the $$$ costs and personnel to manage mountains of nearly worthless 'paper', the risk exposure for non-compliance, etc...

Why not harmonize your CSV and other compliance obligations into a common technology platform and start saving time & $$$?

PENSA's solution is TVM software (The Validation Manager) and it is being used by others to achieve & maintain FDA and SEC compliance:

With TVM you can harmonize CSV and compliance across all FDA & SEC operations, create & enforce compliance consistency, enforce your corporate regulatory policy, greatly reduce attrition exposure, eliminate $$$ budgets for outside consultants, manage compliance work-flow, increase ROI $$$ on software maintenance contracts, eliminate internal regulatory conflicts of interest, and a lot more...

PENSA maintains updated, off-the-shelf configurations of popular enterprise systems such as ERP (PeopleSoft 'Enterprise' and 'Enterprise One'), PLM/EDMS ( Agile), LIMS, etc... Interested? Want to save $$$? Want to increase compliance at a rational cost? Want additional Info?

Contact us for more info about PENSA and a WebEx demo of TVM.

 


 

Sarbanes Oxley in the News

ALEXANDRIA VA USA (Medical Industry Email News ServiceTM )-- AUG 25 2004 -- According to recent data, the cost of being public in the era of Sarbanes-Oxley continues to increase significantly. In the Aug 16 issue of Rx Compliance Report, new data from Foley & Lardner show a 130% increase in costs for public companies to comply with new requirements.

*Schering-Plough settles drug pricing suit for $345 million.

*SEC levies $150 million penalty on BMS for accounting irregularities.


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Rx Compliance Report-- AUG 16 2004-- SCHERING-PLOUGH & BRISTOL-MYERS SQUIBB SETTLE INVESTIGATIONS FOR COMBINED HALF-BILLION DOLLARS:

In recent weeks, Schering-Plough and Bristol-Myers Squibb paid a combined half billion dollars to settle fraud investigations. In addition, both companies face ongoing investigations.

Schering-Plough's compliance chief, Brent Saunders, outlines new challenges facing drug and device companies, and he suggests a response. "What the industry needs to do," says Saunders, "is to create broad-spectrum comprehensive enterprise-wide programs."...

...like PENSA's compliance management application "The Validation Manager"...read on