Medical Writing is the basic work of any medical or clinical study or Clinical case. Every medical study or the treatment and clinical research study starts of from the basic document available. These documents are authored by the professional medical writers. Medical writers over the years have been limited to paper based approach.
Medical writers follow a level of hierarchy, before the final version release of a medical document. A medical document comes out of the following hierarchy, Writer-Reviewer-Approver. In paper based approach it was tough to follow this as there were huge papers to be written, reviewed and approved. Versioning of the documents was also a laborious task eating away huge amount of time.
With the paper based approach one other disavantage was security of information and previliges with respect to roles and responsibilities is another area of the challenges presented by the paper based approach. One to One reltation among Writer-Reviewer-Approver was itself a tedious task, Many to Many reltation among Writer-Reviewer-Approver is a herculean task which is the most important requirement in today environment of clinical trials.
The solution to all this is through computer based independent softwares to manage the Writer-Reviewer-Approver relation and to bring out a most perfect medical document to store based on which the rest of the clinical study is conducted. The present industry standard of 21 CFR Part 11 suggests the usage of Electronic Signatures of better security of information that even suits the audit trial at any given point of time.
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