ClinAxys® II - Details
ClinAxys® II is a feature rich clinical pathology laboratory information system (LIS) that includes all of the following functions:-
- Entry and editing of study protocol information
- Specimen tracking
- Fast access to accurate information
- Rapid data entry with bar-coded label production
- A user-friendly interface
- Flexible reporting
- Alert flagging of problems or demographic 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
- Multiple global laboratories running on a single database
- General File Import module for importing e.g. Spreadsheets directly into the ClinAxys Database
- Dynamic link to external Relational Databases
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.
Compliance with national and international regulations and guidance, such as the United States Federal Regulations, EU Regulations and OECD Guidelines is vitally important when you are engaged in Clinical Trials or Pre-Clinical Drug Safety studies. A topical example is the United States Code of Federal Regulations 21 Part 11 (21 CFR Part 11) concerning electronic signatures.
ClinAxys® II provides the user with the components needed to assist compliance with 21 CFR part 11, as administered by the United States Food and Drug Administration (FDA). It provides the components that will assist compliance with other US Regulations and FDA Guidance as well as the requirements and recommendations of other regulators such as the OECD, EU and the UK Department of Health.
ClinAxys® II is continually updated to be in accordance with current industry recommendations and best practice as well as recent changes to regulations and guidance.
