Product Information

MasterControl Process™

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Data Sheet 3 MasterControl Process™ Compliant: MasterControl helps companies attain continuous compliance by simplifying and optimizing workflows, enforcing procedures, and lowering overall compliance cost. • Automated Processes: Automation helps simplify the compliance environment by enforcing the procedures related to each process while enabling the decision making abilities of qualified personnel. • Flexibility in Workflow Design: Process designers can configure all aspects of a workflow, including the assigned users, what users can do with the task (such as rejecting or approving it), the number of approvers required to move to the next step, which pages are viewable or editable, which users are allowed to change user assignments to the step, and when the task escalates to another set of users. These features and many more ensure that virtually any process can be accommodated. • Streamlined Performer/Witness Signoff: A process step can be configured to allow two people to sign off from a single screen. This is necessary for tasks that require a witness during completion (e.g., electronic batch records) and eliminates the need for one user to log out and another to log back in so the second signature can be committed. • Concise Signature Meaning: The signature meaning can be configured for each step and is displayed in all views of the signature record: the sign-off dialog, the tracking entry, and on the signature manifest. • Analytics and Reporting: Pre-configured reports for a process are created in MasterControl's Analytics tool, allowing for advanced data analysis. These reports can include any user-entered data as well as metadata on the process task. Reports can also include pie charts, bar charts, trend charts with drill-down capabilities, and are easily modified by end users. Chart dashboards provide a quick overview of current activity and scheduled reporting assists in regular reviews of key data. • Part 11-Compliant Features: MasterControl provides time-stamped audit trail, reporting, and electronic signature capabilities that fully satisfy FDA's 21 CFR Part 11 requirements. Security features include dual passwords for document approval; password expiration, encryption, and certification. Account lockout stops unauthorized users from gaining system access. Connected: MasterControl connects processes to each other as well as centralized data repositories in MasterControl or third-party databases eliminating duplicate repositories. • Web-Based Platform: MasterControl is Web-based and connects all employees and other authorized users regardless of location.

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