Document Management (DMS)
We recognize that meeting & remaining compliant with FDA 21 CFR Part 11 and International standards is imperative to your business. PharmaReady DMS, a web-based Training Document Management System, automates and seamlessly manages your document control process to ensure compliance with these regulations. Unlike competitive products PharmaReady is specifically designed for Life Sciences organizations where ease of installation, ease of use, regulatory compliance, and affordability are the primary business drivers.
PharmaReady DMS manages the entire document life-cycle process and gives you the tools to securely manage a wide range of business documents, including those related to regulated environments.
PharmaReady DMS is a fully 21 CFR Part 11 compliant document management solution based on Microsoft Windows technology. PharmaReady DMS is designed specifically for management of SOPs, Work Instructions, and other documents within business areas regulated by the FDA.
- Automated Numbering: Document Number Manager keeps track of the numbers you assign to SOPs and validation documents.
- Revision Control: Automatic document revision control to ensure the most up-to-date information is available
- Complete Audit Trail: Secure, time-stamped audit trail meeting 21 CFR Part 11 Requirements
- Electronic Signature: Electronically signoff and approve documents
- Custom Standardized Templates: Document Template Manager helps standardize document formats and jump-start the process of creating new documents.
- Scheduled Publishing: Publishing Manager helps with the process of timing the release of updated or new documents, managing retention schedules, and automatic PDF rendering.
- Control & Track Distribution: Distribution Manager helps organize the distribution of documents and tracks who has seen them.
- Advanced Audit Logs: An extensive Auditing feature automatically logs critical activities and presents audit records for on-line analysis.
- Qualification Execution: Executed Installation and Operational Qualification documents.
- Loss Recovery: Administration Manuals and SOPs for back-up and recovery.
- Easy Access: Access PharmaReady online anytime of the day or night
- Fully Integrated: PharmaReady DMS fully integrates with PharmaReady eCTD, SPL, and TRMS.
- Audit Log Viewer: Activities related to documents and users are fully audited. An on-line Audit Log Viewer provides authorized personnel a way to see the entire history of activity for a specific document, or everything a specific User has done on the system.
- User Management: User Management is a key component of any controlled system. PharmaReady implements secure user accounts with logon and password credentials. Users have access to functions and documents based on access rights assigned to Roles.
- Validation and Implementation Services: Part 11 compliance and validation is dependent on how a system is implemented. TAKE Solutions’ professional services are a key component in the sale of PharmaReady. These services will ensure that every implementation is performed properly and that all documentation is provided.
- Price: PharmaReady is priced substantially lower than any other product that offers similar functionality for a validated system that is Part 11 compliant
Learn more about how PharmaReady DMS can easily and seamlessly integrate with PharmaReady eCTD, SPL and TRMS. |
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