Document Management

Document management and document control are important parts of an organisation’s quality operations. Good manufacturing practices (GMP), FDA regulations, ISO requirements and other governing regulations and standards require that companies manage document versions, control which documents are available to employees, and ensure that appropriate change control procedures are followed when revising documents.

Many organisations employ a conglomeration of systems ranging from manual processes to legacy or point solutions. As a result, companies struggle to achieve a collaborative and controlled work environment. Many incur high costs related to managing documents and other content while concurrently facing compliance and operational risks.

TrackWise document management solutions

Sparta Systems’ TrackWise enables companies to reduce costs of compliance and increase control over their operations by providing globally scalable solutions for fully integrated quality management systems (QMS) and electronic document management systems (EDMS). The TrackWise Document Management™ solution provides companies in quality management environments with a comprehensive document management system built on the powerful and industry trusted Documentum ECM Platform®.

TrackWise enables employees to access controlled documents and perform all lifecycle management activities from an integrated TrackWise system. The TrackWise solution reduces costs and increases productivity by presenting a consolidated system for all quality management and document management needs, while allowing organisations to use best-in-class software for both functions.

Document management applications

• SOPs, policies, work instructions
• Batch records
• Certificates of analysis (COAs)
• Regulatory submissions
• Regulatory correspondence
• CAPA objective evidence
• Documentation related to change control
• Validation documentation
• Manuals, instructions
• Employee training and qualification records
• Project documentation
• Investigation documents, photographs, etc.
• Contractor batch records, quality records
• Audit reports and follow-ups
• Many others…

Benefits

• Ensure compliance by establishing centralised and controlled repositories for policies, procedures, and other controlled content
• Improve control of sensitive data by enforcing role based security rights for access to documents and other content
• Enhance collaboration and achieve better results by enhancing review cycles and improving search and retrieve capabilities
• Increase productivity by creating an electronic review and approval process and automating workflow steps based on document type, process area, and change level
• Reduce the risk of deviations resulting from employee access to outdated or obsolete procedures and work instructions
• Reduce time, effort, and costs associated with manual, paper-based processes and lengthy review cycles
• Improve quality by integrating TrackWise quality management processes with document management functions using a best-of-breed approach
• Create a scalable framework that allows your organisation to add additional document types and processes to further increase worker productivity and foster continuous improvement