Document Control and SOP/Document Management

Quality Manager document control module allows companies to automate and manage internal and external documentation for use in ISO and FDA-regulated environments. It provides a secure electronic environment for change management that includes revision control, electronic document approval, and automatic document distribution. Users are required to use their electronic signature to acknowledge they have read and understood the updated document, simplifying the documentation and enforcement of updates.

Standard operating procedures (SOP) and production information such as drawings and specifications can be viewed, approved, and distributed in real-time. Documents are organized in electronic filing cabinets similar to Microsoft Explorer with a full security model that allows users to access cabinets based on their permissions. Read-only user’s access is restricted to documents in the “Released” cabinet, ensuring employees are always up to date.

Title21 Software Document Control manages documents regardless of the software used to create them. Each document has an index card which tracks the history of authorized users that checked the documents out for edits, any links between documents or quality events, and the electronic signatures of approvers. Index cards can be sent around a predefined route for approval or approvers can be added/substituted to a single document. Electronic signatures can be applied to a group of documents making annual document reviews more efficient.

Groups are able to work collaboratively using the task manager. Tasks can be set to be dependent on another task to increase efficiencies of review. Since only one person can actively change the document, there is no risk of duplication or unintentional overwriting of changes. Automatic emailed reports give managers an overview of completed and outstanding tasks. New tasks are automatically sent via email to Outlook or other email systems, so users do not need to be logged into the system to be up to date on their workload. Overdue tasks are escalated to help keep document reviews on track and on time.

When implemented with Quality Manager’s Training Module users are notified via email when updated SOPs or other documents requiring retraining is required, and tracks which users have completed the training by the due date. Automatic reports are generated and emailed to managers keeping them up to date on the progress of the training before the documents are released.

Integration with the Quality Module completes the “closed loop” system for a comprehensive Quality Management System. Corrective and preventive actions, complaint handling, equipment calibration, deviations, etc. findings can be linked to document changes enabling you to manage quality and compliance across your entire business, helping you meet regulatory requirements, increase efficiency and reduce costs.

Easy search queries are available by document title or number, author, or key words inside of document. Users are also able to “file” documents in secure filing cabinets within the system to organize documents in a manner that is logical to them. Queries can be saved for future use.