Whether you are engaged in Clinical Trials or Pre-Clinical Drug Safety, one of the key requirements is the ability to comply with the United States Food and Drug Administration Regulations e.g. 21 cfr part 11. ClinAxys II® provides the user with all the facilities to operate the system in a 21 cfr part 11 compliant manner

ClinAxys II® meets the requirements of a clinical pathology laboratory information system with the following features:-

• Entry and editing of study protocol information
• Specimen tracking
• Fast access to accurate information
• Rapid data entry
• A user-friendly interface
• Flexible reporting
• Early flagging of problems or inconsistencies
• The ability to add modules as requirements change
• On-line data capture for leading makes of instrumentation
• An automatic audit trail of all changes and activities
• Data flagged against study-specific reference values
• 21 CFR Part 11 facilities
• A full quality control package

ClinAxys II® can process large volumes of data from both on-line and manual sources simultaneously and is designed to comply with current Good Laboratory Practice requirements at all times.