The heart of any Generic Drug or API manufacturing organization are its Standard Operating Procedures (SOPs) and their related Work Instructions and Forms. The ability to quickly search for the required content and then view and print in a controlled manor means that users spend less time searching for content and more time using it to perform revenue generating tasks. Users must have confidence that they are using the current, controlled version of the document and that all hardcopies are watermarked for their intended use. That in conjunction with a fully compliant audit trail means that audits by agencies and customers are conducted in a timely fashion without observations or non-conformances.
Standard Operating Procedures (SOPs) are put in place to ensure that employees operate in an effective, safe and efficient manner and users must demonstrate that they are proficient in their daily tasks, as laid out in SOPs. With the QUMAS SOP Management Solution, users have easy access to the SOPs that are relevant to their work, and have the ability to search for content, view it, and print it - as long as they have relevant permissions.
To understand the core capabilities of effective SOP management, download this webinar Driving Business & Quality Success with an Integrated QMS Platform, which outlines a repeatable process for document lifecycle management including:
- Consumer User Activities: Viewing, Searching , Printing, R&U Training
- Document Workflow Activities, Edit, Review, 21 CFR Part 11 approval
Watch these webinars to learn more about the changes in the regulation of the Generics Industry, and how to address them: