Document Management

As we know, paper has been on its way out of the office for some time, but just because we have moved to digital information sharing, that does not mean our information is more organized or that we have efficient access. When it comes to quality management, document disorganization can lead to adverse quality events, FDA findings and potentially plant shutdowns. 

For both large and small organizations, quality document management systems have been a game changer. The ability to simplify the document management process by organizing all documents into a centralized warehouse with approval workflows and audit trails helps to eliminate document redundancy, reduce the risk of manufacturing products with unapproved or out of date SOPs, drive efficiency in organizing all of the documents that come from suppliers and CMOs and ease the burden of regulatory compliance.

Sparta Systems offers two solutions for document management:

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

  2. For customers that need a document management system to be part of their enterprise quality management implementation, there are cloud based document management solutions available. Sparta’s cloud based DMS offers the features expected in a high performing DMS, including security/role-based access, version control, document workflows with notifications, watermarking and expiration management.

Optimizing the Relationship between Quality Management and Document Management

Benefits of Sparta Systems' Document Management Software

  • Choice – customer can leverage Sparta’s cloud document management systems or integrate to the document management system they have already invested in.
  • Gain control of GxP documents
  • Increased efficiency
  • Audit readiness
  • Accelerates change control and review cycles
  • Reduces the risk of incomplete or incorrect change control efforts
  • Reduces time, effort and costs associated with manual, paper-based document management processes

Capabilities of Sparta Systems' Document Management Solutions:

  • Document 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 CAPA and action plans
  • Enforces document control and data security as dictated by document management system permissions
  • Provides integrated search and retrieval capabilities within the quality management environment
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