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Document Control Software Module

Document Control

Scope

The uniPoint Document Control Software Module is the focal point of our Continuous Improvement Suite, because it manages all types of documents, regardless of the software used to create them. It provides a central and secure repository that makes search and retrieval easy during inspections and audits.

Advantages

Improve efficiency and compliance requirements by automating your manual document control with sign-off and change control. Ensure that your company is building its products using the most current specs. Other advantages are:

Key Features

  • Helps customers achieve/maintain compliance to FDA 21 CFR Part 11 and Part 820
  • Track all Company Documents (grouped by type and category) in a master database.
  • Ability to control document approval sources, and complete distribution lists on a per document basis
  • Track status of documents (active, pending, obsolete)
  • Track document revision changes, and quickly copy old revisions to new revision, complete with existing approval and distribution lists
  • Ability to search, list, find all company documents by status or distribution
  • Ability to Link to actual document file path, or web page, and view document on-line
  • Excellent tool for confirming status of documents and distributions during audits
  • Digital Signatures
  • Encrypted Sign-off Passwords
  • Optional Strict Revision Control
  • Increased Management Visibility
  • Advanced Search Tools
  • Setup Sign-off/Distributions
  • Email Revision changes to Employees

General Capabilities

  • Specific E-mail Notification
  • Standard Text Manager
  • Unlimited Attachments
  • Update User To-Do Lists
  • See Historical Audit Trail

Reporting

  • Document Report, with digital signature
  • Document Reviews
  • Document Distribution List
  • Document History Report
  • Document Acknowledgments Outstanding
  • Document Acknowledgment History
  • Document Sign-Offs Outstanding
  • Document Sign-Off History

Advanced Features

  • Consolidate documents automatically into a specified location
  • Have complete control over versioning and changes with check-in and check-out
  • Control access to files with user level security
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Concurrent Users:
Core Modules
Add-On Modules
Web Modules

Compliance

uniPoint is a compliance tool for the strictest quality requirements of your industry.

Simplicity

Our interface promotes engaged users, and lower on-going training costs.

Integration

Eliminate redundant data entry and leverage the data from your existing systems.

Benefits

Track the frequency and cost of quality events, with our ISO-ready suite of modules.