FDA Regulated Industry
There is just too much information required to run a company regulated by the
FDA. Just to create a product you need to create a full dossier documenting
the processes used and the testing procedures and results. Hopefully your system is
sophisticated enough to electronically submit your dossier so you can cut your evaluation
period down by an average of 20%. And once the product has been registered an FDA
regulated company must manufacture and sell the product. Manufacturing requires a new
volume of information to control the process, ensure quality and track each batch.
This new volume of information includes policies and procedures to be followed, as well
as, other related enterprise documents. Add the effort required for
ISO/9000/ISO14000 certification and tougher compliance requirements of regulatory agencies
such as FDA and OSHA, and this information management would be insurmountable without the
proper tools.
What is needed is an Information System that can manage your data before during and
after the manufacturing process which includes:
- Enabling the sharing of data with research partners inside and outside the company
- Providing the right people with the right information at the right time
- Effectively utilizing e-mail, Intranet, and other technology platforms.
The challenge is to integrate and implement the new solutions with the old to closely
align with your business strategies. Cimage is among a select few EDMS vendors who realizes that an EDMS system is only one ingredient in an overall
solution. That's why we've partnered with leading integrators who provide domain
expertise. That way, Cimage and our partners can uniquely meet the business requirements
of your specific industry. Together we will help you build a system that considers the old
takes advantage of the new and allows you to:
- Launch new and innovative products
- Develop products more rapidly
- Introduce these products globally
- And have access to partners outside of your company.
Links:
www.21CFRpart11.com:
Information on 21CFR Part 11 compliance and a site to actively
discuss issues and concerns with industry peers and government regulators.
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