The costs of not switching over to electronic record-keeping and associated signatures are too great for many in the affected industries to ignore. By switching to electronic solutions, companies expect to benefit in many ways.

Like all strategic Information Technology initiatives, one of the important rules of thumb is to avoid "reinventing the wheel" when a great deal of the thinking has been completed elsewhere. This is where Maxima's consulting specialists are of great value to our customers.

It is generally accepted that the implementation of CFR 21 part 11 is not a technology issue. The technology required currently exists and is being used by Life Sciences companies all over the world very successfully. The problem lies in the alignment of People, Processes and Technology.

Our experienced Consulting team have developed approaches and methodologies to dealing with this problem in relation to CFR 21 part 11. Our approach is one of hands on. Our initial objective is to assist your organisation to identify and realise the quick wins that are essential to kick starting a CFR 21 part 11 project. Given the challenges posed by CFR 21 part 11, our belief is that success can only be achieved by adopting a Rapid Deployment Approach (RDA).

The types of benefits that derive from a successful CFR 21 part 11 project are:

Improved ability for the firm to analyse trends, problems, etc., enhancing internal evaluation and quality control.
Reduced data entry errors, due to automated checks.
Reduced costs of storage space.
Reduced shipping costs for data transmission to FDA.
More efficient FDA reviews and approvals of FDA-regulated products.
Manufacturing process streamlining.
Increased speed of information exchange.
Product improvement.
Enabling of more advanced searches of information, thus - obviating the need for manual paper searches.
Multiple perspective views of information.
Avoidance of document misfiling from human error.

Maxima's consulting team can deliver these and other benefits, which greatly outweigh any associated costs of implementing CFR 21 part 11 for your organisations.

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" What impressed me about Maxima was their ability and willingness to really understand our business issues and how technology could deliver improvements. They appreciate the big picture. "