Title21 Software helps firms in the life science industries effectively manage their quality, regulatory and other compliance resources. Our flagship product Quality Manager™ is a suite of best-in-class tools for the management of issues, data, documents and training. This is the easiest product in the marketplace today to configure, validate and use.

Title21 Software solutions are highly scalable and each comes with a host of preconfigured forms and workflows that you can use “right out of the box”, or change to meet your specific business needs. All Title21 Software products are 21 CFR Part 11 compliant and can be used to implement cGxP’s, ISO 9000, IS0 13485 and other regulatory regulations.

Our integrated Quality Management Solution handles the following quality events, and more:

• Audit Management
• Batch Records System (EBR)
• Change Control
• Complaints Handling
• Corrective/Preventive Actions (CAPA)   
• Deviations
• Device History Records (DHR)
• Device Master Record Management
• Document Control
• Engineering Change Orders (ECO)
• Equipment Calibration
• Field Service
• Inspection, Test Data and
  Acceptance Records

• Investigations
• Labeling Management
• Nonconformance Management
• Out of Specification (OOS)
• Post Marketing Surveillance
• Product Traceability
• Returned Materials
• Service Records
• SOP and Document Management
• Statistical Process Control (SPC)
• Supplier Quality Management
• Test Records
• Training Management
  and Certification
"Title21 Software has allowed us to take our customer issue, complaint and corrective action processes to the next level. It has improved the responsiveness to our customers and has significantly decreased the number of man-hours spent on processing customer issues..."

Eric Earnst
Engineering Manager
Accuray, Inc.
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