Document Control and Management for Quality

Easy-to-Use Document Control for FDA Regulated Companies

Document control is essential for FDA regulated companies. Yet many manufacturers still use paper-based documents. It is a practice that is risky and inefficient, as well as costly.  The use of paper documents can lead to adverse quality events, FDA findings, and even plant shutdowns.

Centralized Document Control and Management

In order to mitigate these risks and improve efficiency, more manufacturers are investing in a centralized document management solution that serves as the single source of truth for all documents related to quality, processes, and manufacturing.

The Benefits of Sparta Documentation Control Software

Sparta offers built-in document control and management capabilities, and can integrate with your pre-existing doc control solution. You can easily integrate your documents and quality processes, map approval workflows and streamline processes to prevent quality issues from becoming widespread.

Audit trails help to eliminate document redundancy, reduce the risk of manufacturing products with unapproved or out-of-date standard operating procedures (SOPs).  You can more efficiently organize documents tied to suppliers and contract manufacturing organizations (CMOs) and ease the burden of regulatory compliance.

Doc Control Capabilities That Meet Your Needs

  • Documents creation leveraging simple templates.
  • Document redlining.
  • Full audit trail – capture all activities related to managing a document.
  • Sophisticated change control workflows and enforcement.
  • Document changes trigger updated training requirements for employees impacted by the change.
  • Seamless integration with quality management activities such as corrective and preventative actions (CAPAs).
  • Enforces document control and data security as dictated by document management system permissions.
  • Provides integrated search and retrieval capabilities within the quality management environment.

Connect to An Existing Document Control and Management Solution

For customers that have made an investment in an enterprise quality document management system, out-of-the-box integration through the Sparta QualityConnect Partner Program is the optimal choice.  Technology partners have written off the shelf integration to systems like SharePoint® and Documentum®.

See TrackWise Document Management in Action

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