The eDocument Management System for pharmaceutical industry and “quality-oriented” organizations
The eDMS for GxP documents web-based and fully compliant with 21 cfr part 11 rule, webDoc is the solution to manage company documents and procedures in compliance with international standards.
The system allows to easily track the lifecycle of the editions of any document, from the initial request to the final release, and it is ready for paper-less environments thanks to electronic signatures features.
Request for issuing of new document
webDoc allows the preparation and sending out for approval of a request for the issuance of new document or new issue.
Once approved, the request enables the editor to prepare a document in Word format from a template or from the previous edition.
In succession, the following steps are provided:
- document’s check-in and automatic generation of PDF
- completion of the document data (cited documents, attachments, type of target readers, any reviewer, signatories, target departments, etc.)
- collaborative review
- sending to approval
The electronic signature of documents and requests for new document is run through work-flow defined by the system administrator for each type of document.
The system can associate to each type of document a period after which the document should be reviewed.
The decision will be to extend the deadline or to issue a request for a new edition.
The system administrator has some functions to deal with events such as make obsolete a document or change the editor.
He/she can also analyze all requests for new document and all documents in any state to examine signatures, changes of status, previous editions, and so on.
All authorized users can view official documents using powerful search functions.
The system provides functions for official printing and controlled reprinting with specific watermarks.
Electronic records traceability
webDoc faithfully comply with international standards, in particular rule 21 CFR Part 11, issued by the FDA:
- the user involved in the documents life cycle is guided by the system in the execution of the activities
- specific tasks require entering the password
- user profiles are managed by an administrator who specifies access privileges to functions
- user Id is not reusable
- password control is governed by rules defined by the administrator
- intrusion attempts are recorded and, if more than limit imposed, “freezes” the user
- all transactions on the documents are recorded, with date and signature, and viewable through specific functions
All the activities of maintenance, development and support of the product are governed by corporate methodology, which guarantees an orderly and highly reliable process in both software development and assistance to the customer.
The built-in integration between webDoc and webTraining provides a complete and easily implementable solution for GxP documents management in the Pharmaceutical Industry.
webDoc combines the solidity of standard J EE (Java Enterprise Edition) architecture and Oracle database with the simplicity and effectiveness of web based User Interface.