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Solutions for
Managing SOP Documents
Industry Environment
Even a very fast reading of the GxPs for the United States, Canada, and the European Union will reveal a phrase that is repeated over and over: "There shall be procedures for…" Having and using documented procedures is a way of life in pharmaceutical and biological companies.
SOPs (Standard Operating Procedures) are essential in maintaining quality and safety standards in regulated industries. They are a key part of operations in a regulated facility and are intended to ensure that personnel are working safely and in compliance with regulations. Whether or not an industry imposes specific requirements, managing SOPs in a controlled manner should be implemented as a standard business practice.
Challenges
Paper-based SOPs are often lengthy and quite dry and unengaging for the learner. Much time can be spent on reinforcing and revising SOP content even after the user has been trained on it. A growing trend in regulated industries is conversion of static, paper-based SOPs to electronic SOPs.
Automating the handling of eSOPs in a controlled manner yields a speedy return on investment and dramatically improves operating efficiency. Combined with a specialized EDMS, such approaches as document delivery, reading confirmation, authoring workflows and electronic signature support the organisation management of SOP and reduces the burden of the QA person at the same time as being compliant with quality requirements from agencies such as the FDA's.
Software Solution
Life Sciences and Pharmaceutical companies deploy MxDoc for supporting their SOP management needs. Out-of-the-box MxDoc includes everything required to support the QA group needs: customized revision management, intuitive workflows and electronic signature, automated PDF conversion, Reading confirmation, change notification and much more.
 MxDoc Document Management Solution
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