QUMAS continues to deliver compelling and thought-provoking papers and guides for financial services and life sciences companies to help in the evaluation process for governance, risk and compliance solutions.
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Streamlining and Accelerating Change Control in Today's Complex Life Sciences Organizations
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Sound Document Management Lays the Groundwork for Life Sciences Regulatory Publishing
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Seven Total Costs of Ownership Truths
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In today’s highly regulated life sciences environment, organizations face a myriad of regulations and regulators, affecting all aspects of the enterprise. One area coming under increased regulatory scrutiny is change control: the ability to manage deviations to established policies and procedures in a way that is efficient, timely and compliant.
Document management is nothing new to regulatory affairs professionals. Long before the Food and Drug Administration (FDA) and other regulatory bodies began developing their first guidance for submission format and content, regulatory affairs professionals had to contend with the challenges of gathering and managing documents from disparate functional groups including clinical, non-clinical, manufacturing and drug safety. This collection of information must be carefully organized to facilitate the bidirectional exchange of information between the applicants and regulatory agencies to meet guidelines such as those imposed for an Investigational New Drug Application (IND) or a New Drug Application (NDA). Selecting the right EDM system and combining it with a submission publishing tool can be an highly effective way to reduce the time required to approve, publish and submit documents.
When considering the purchase of a technology solution, many organizations mistakenly look only at the initial price tag of the software or hardware without considering all of the other factors that can affect the Total Cost of Ownership (TCO). These additional costs add up over time and can include customization, training and the overall costs to keep software up and running after the initial deployment. QUMAS developed this white paper to provide insight and guidance into the TCO process and its place in the overall solution sourcing and management process. Using this guidance and a calculator template included in the paper, you will be able to build an objective model that will assist you in differentiating and analyzing alternative solutions as well as addressing the "build vs. buy" dilemma.
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