21 CFR Part 11 Compliance.com

 

Company Info. Center Support Contacts OEM



  

 

   

 

Document Creation, Review, Approve & Distribution System

DocMan allows you to create, review, approve and distribute documents (SOPs, ISO 9000 quality guidelines,..) in a controlled and Part 11 compliant environment.  Find out how to comply and increase productivity using this innovative tool.

 DocMan®
 

       

Innovative Automation’s DocMan™ Portal Server extends the capabilities of a traditional LIMS (Laboratory Information Management System) by offering scientists and knowledge workers a powerful new way to organize, find, and share regulated and controlled information. For QA (Quality Assurance) and RCV (Regulatory Compliance and Validation) managers, DocMan Portal Server is a solution that delivers dramatic new value by combining the ability to easily create corporate or departmental web portals with document management, enterprise content indexing, and team collaboration features.

DocMan™ lets you transform current non-compliant document repositories (SOP, Study/Protocol contracts, HR training records,  MS Excel® spreadsheets, MS Word® documents and other business contents) into an automated, secure and audited environment, resulting in better compliance with government (21 CFR Part 11, GLP, GMP-compliance) and industry regulations (ISO standards) and good business practices. By automating the process of document creation, review, revision, approval, distribution and controlled access/sharing, DocMan helps companies bring products and services to market faster and with greater confidence.

Finally, your SOPs, Study/Protocol contracts, Excel®-based reports and Word® documents will successfully sustain the rigors of any inspection, including inspections from international regulatory bodies.

DocMan™ ensures authenticity and integrity of all documents created and modified within its repository via a system of user identification, audit trail, e-signature, encryption and a unique document database.

Key Features
  • Enables companies to automate the creation and management of controlled content through an easy-to-use, intuitive application and distribution via a Web-based application, resulting in better compliance and product quality as well as substantial time and cost savings

  • Easily handles all types of controlled content – including engineering drawings, standard operating procedures (SOPs), material safety data sheets, work instructions, test protocols, and product and packaging specifications

  • Promotes compliance with Good Manufacturing Practices (cGMP), GLP, OSHA regulations, ISO 9000 quality guidelines, and 21-CFR-Part 11 electronic record-keeping regulations

 

Excel® and Word® are trademarks of Microsoft.