In R&D and manufacturing, Standard Operating Procedures (SOPs) define the business rules and processes for everything from pre-clinical research, clinical development, and equipment operation to the release of new products. Like any other business-critical information, standard operating procedures must be managed effectively. Poor capture, review, and distribution of these assets routinely cause expensive production delays and errors. In fact a large percentage of FDA 483 citations are related to documentation that is not current or easily accessible to employees. Moreover, paper-based methods of maintaining regulated information are costly and extremely difficult to maintain as standard operating procedures for R&D and manufacturing become more complex.

SOP management with QUMAS assures compliance with all cGMP requirements for procedure management and enables compliance with 21 CFR Part 11. Reliance on the QUMAS closed-loop quality management process assures that employees have immediate access to the most recent SOPs while providing an audit trail that validates the SOP delivery and change process.

Benefits:

QUMAS SOP management solutions help today's R&D and manufacturing organizations administer complex standard operating procedures:

• Automates the creation, sharing, distribution and management of SOPs across a global network with electronic workflow, review, and annotation
• Reduces the expense related to the creation, review, approval and distribution of business-critical content by 20 to 40 percent - expedites the review cycle by eliminating the time a typical worker spends simply looking for information (estimated at 20 to 30 percent of the work day by AMR Research)
• Tracks SOP lifecycles - who has it, who needs to review and approve it at any time, when is it mandated for a periodic review
• Versioning assures reviewers always have the "right" document - version compare facilitates the easy identification of updates between versions
• Controlled viewing and printing including watermarks and overlays and hard copy destruction management
• Delivers rapid search capability by producing only the most current SOP, rather than multiple versions
• Adheres to the FDA 21 CFR Part 11 password and audit trail requirements
• Role-based permissions ensure content and IP security
• Reduces submission time when integrated with eCTD builders
• Pre-defined, fixed-deliverable configurations appropriate to biotechs and other firms with rigid requirements are also available