Making 21 CFR
Part 11 work for you
All modern manufacturers
face the challenge of successfully integrating their various computer
systems into a workable whole. But organizations in the healthcare
field must cope with an additional level of complexity: The FDA's
21 CFR Part 11 allows and sets guidelines for electronic signatures
in each step of the approval process.
Compliance means new
requirements for your system, and demands validation at each step,
from documentation before start-up to archival storage - years,
or even decades later. There is a great deal more involved with
21 CFR Part 11 than just the electronic signatures it allows for.
For instance:
- Many legacy systems
cannot comply with the FDA's rigorous standards. Most cannot create
audit trails as they handle data.
- Automated laboratory
information systems and clinical trial databases can be particularly
difficult to integrate with existing systems due to the large
amount of data involved
- Long-term storage
of all relevant documentation demands good Enterprise Resource
Planning…or fails.
Overall, 21 CFR Part 11 represents a big step forward for the industry.
It allows the digital storage and transfer of records that were
previously held only in paper form. This is a great improvement
in both cost and method, but it brings new challenges to your information
systems.
For a system
you can rely on, trust Oracle
Oracle Discrete Manufacturing
provides the functionality that you need. It supports all current
compliance and safety standards, including enhanced global sourcing
and electronic-signature control. And Oracle E-Records is a configurable
framework for securely capturing, storing, querying and printing
electronic records and electronic signatures, in full compliance
with 21 CFR Part 11.
Oracle E-Records lowers
the cost of compliance by streamlining your compliance activities.
That is why 16 of the top 20 medical device companies trust Oracle
in their operations.
Oracle's Power, Colibri's expertise
Rely on Colibri for the
expertise and technical knowledge necessary to install and adapt
Oracle's eBusiness Suite and E-Records for your operations. Colibri's
average associate has over 9 years experience in dealing with exactly
the challenges you will face. And Colibri is focused solely on Oracle
systems. We give you access to information gained from successful
Oracle implementations in dozens of industries.
And Colibri is experienced
with the particular challenges and techniques of medical device
manufacturing. We will help you get the most from Oracle's offerings…and
from your business.
Contact
us here to discuss your situation. You will be glad you did.
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