SOP Management
In R&D and manufacturing, Standard Operating Procedures (SOPs) define the business rules and procedures for everything from pre-clinical research, clinical development and equipment operation to the release of new products. Like any other business-critical information, SOPs 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 with the increasing complexity of R&D and manufacturing processes.
Implementing 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 employees have immediate access to the most recent SOPs while providing an audit trail that validates the SOP delivery and change process.
Benefits:
- 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