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 are critical to operations. 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and audit trails helps to eliminate document redundancy, reduce the risk of manufacturing products with unapproved or out-of-date standard operating procedures (SOPs), drive efficiency in organizing all of the documents that come from suppliers and contract manufacturingg organizations (CMOs) and ease the burden of regulatory compliance.
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.
QualityConnect Partner Program
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®.