eInfotree QMS

eInfotree QMS is a Quality Management System developed by CIMCON Software that delivers a unified approach to Enterprise Information Management by linking data and business processes in a highly intuitive, browser-based environment. Designed for life sciences and regulated industries, it is fully compliant with 21 CFR Part 11, supporting electronic signatures, audit trails, and role-based security. The platform serves organizations from the plant floor to the executive level, helping them capture, process, and manage information more efficiently to reduce costs, improve service levels, and accelerate project and customer response times.

eInfotree QMS is complemented by a range of modules that add value across key application areas, and is available as both a SaaS-hosted solution and an on-premise deployment. It has been adopted enterprise-wide by organizations including Charles River Laboratories, with implementations spanning thousands of users across multiple global sites.

Core Document Management Capabilities

• Store and manage files in virtually any format, including Microsoft Word documents, AutoCAD or Visio drawings, spreadsheets, and MS Project schedules.
• Seamlessly link to files on the corporate network or store them securely in the eInfotree database repository.
• Documents are stored in a central, hierarchical repository, creating an organizational knowledge base accessible only to authorized users.
• Version control ensures all users have access to the latest version of a document, with a complete history of all prior versions and version details maintained.
• Folder Synch keeps folders in eInfotree and Windows Explorer automatically synchronized — files added in Explorer are instantly added to eInfotree.

Forms, Data, and Integration Features

• Convert paper forms into electronic forms to enter, approve, and manage data, with configurable validation rules for data entry and meta-data attributes.
• Retrieve values from other applications and define meta-data attributes for structured data management.
• Store data from lab instruments and real-time plant floor devices directly within the system.
• Link to Internet or Intranet web pages such as supplier sites, specification data sheets, or industry references.
• Access the application from mobile phones and tablets for on-the-go usability.

Workflow, Review, and Approvals

• Perform electronic routing of documents for faster approvals, with status tracking and task owner notifications to ensure timely reviews.
• Review tools include file compare, annotations, search, and audit trail to reduce the time and effort required for document review.
• Create custom workflows in minutes using a drag-and-drop workflow designer, with the ability to apply different workflow templates based on document type or department.

Search and Standardization

• Find documents easily based on file name, attributes, meta-data, or document contents.
• Full text search allows users to search all objects in the database using keywords and phrases.
• Standardization tools enable the creation of templates for projects, processes, or systems to improve quality, reduce the learning curve, and promote consistency across the enterprise.

Collaboration and Change Management

• Discussion groups allow teams to discuss issues using threaded conversations organized by topic.
• Notes can be attached to any object using free text, and stakeholder notifications keep all relevant parties informed of events.
• Associations link related documents and data — such as specifications and validation documents — to instantly visualize the impact of changes on related items.
• Configurable change logs can be created to store any relevant data for documents undergoing change.

21 CFR Part 11 Compliance

• Audit Trail: All file and user activity is tracked comprehensively.
• Security: Access to documents and the application is controlled based on roles and privileges, with support for Password Aging and Password Lockout policies.
• Electronic Signatures: Paper signatures are replaced with fully compliant electronic signatures.

eInfotree QMS is available as a SaaS-hosted service, eliminating the need for on-premise hardware and enabling faster implementation and quicker return on investment. It integrates with the eTraininfo Training Module, enabling seamless transition of approved documents into training workflows for all affected users. The platform's scalability and configurability make it suitable for regulated pharmaceutical, biotech, and life sciences environments seeking to achieve paperless operations and robust data integrity governance.