The number of obligatory regulations and standards on document management, such as 21 CFR Part 11 and eCTD, has grown significantly over the last few years. And although compliance failures may entail serious sanctions (production limits, withdrawal of marketing permits, closure of production facilities), in many pharmaceutical companies documentation still plays a subordinate role in critical core processes. The introduction of Enterprise Content Management (ECM) will go a long way in crossing this gap and while there is no single best ECM solution, we help you in discovering the one best suited to your company. We provide tailor-made analysis and orientation workshops for Enterprise Content Management in the area of Drug Regulatory Affairs and quality assurance.
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