Life Science Companies have a head start on Sarbanes-Oxley
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
…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
Contact us for more info about PENSA and a WebEx demo