Sometime it takes too much effort to implement a horizontal document management solution when you have very specific requirements. In this case, a vertical solution makes more sense. Luckily for the Life Sciences vertical, TAKE Solutions has PharmaReady 4.1.
PharmaReady first came to market in 2003 after being introduced with Microsoft as a "an FDA-compliant Document Management System".
Five years later and still going strong, version 4.1 has been announced. PharmaReady 4.1 is a fully integrated web-based document management and electronic submissions solution designed specifically for regulated Life Sciences organizations.
The solution is owned by TAKE Solutions, a business technology company that provides specialized solutions to a number of industries in addition to Life Sciences.
PharmaReady 4.1 Features
PharmaReady 4.1 is a document management and electronic submissions solution suite that is fully FDA 21 CFR Part 11 and cGMP compliant. The solution is designed specifically for documents that are regulated by the FDA including:
* Work Instructions
* Training Records
* Submission Documents
Document Management Features
The PharmaReady DMS is a web-based Document Management System that automates and manages document control processes to help ensure compliance with regulations such as FDA 21 CFR Part 11 and other international standards.
Some features of the DMS include:
* Automated Numbering: Tracks the numbers assigned to SOPs and validation documents
* Revision Control: Ensures the most up to date document is available
* Complete Audit Trail: Secure, time-stamped audit trail meeting 21 CFR Part 11 Requirements
* Electronic Signature: Electronically signoff and approve documents
* Control and Track: Controls who is allowed to view documents and when they are viewed
* Scheduled Publication: Control the release of new documents, publish as PDF and more
* Customized Templates: Create documents from customized templates
Electronic Submissions Features
The DMS is tightly integrated with the eCTD: electronic submissions (eSubmissions ) Common Technical Document solution. PharmaReady 4.1 eCTD meets the new FDA regulation of submitting electronic document via XML instead of PDF.
Key features include:
* Document Assembly: Intuitive electronic content assembly processes.
* Templates: Support for all major regional templates (i.e. EU, US, JP, etc.)
* Lifecycle Management: Submission Life cycle management and consolidated submission reviews.
* Authoring: Role-based document authoring and access management for multi-user electronic submission, authoring and publishing.
Built on the Microsoft Windows platform, PharmaReady is available in both on-site and remote-hosted implementations.
Learn more about PharmaReady or Take Solutions other vertical offerings on their websites.