CALISO - the calibration software for scientists and engineers

Calibration Toolbox - Calibration Management Software - Introduction

ISO 17025, 9001

ISO 17025 was written to incorporate all of the requirements of ISO 9001 that are relevant to the scope of testing and calibration services. It also specifies the technical requirements for technical competence. Testing and calibration laboratories that comply with ISO 17025 will also operate in accordance with the principles of ISO 9001. In the U.S. there are two bodies that are mutually recognized to provide accreditation to ISO/IEC 17025. They are the National Voluntary Laboratory Accreditation Program (NVLAP) and the American Association for Laboratory Accreditation (A2LA). There are many other bodies providing accreditation to ISO/IEC 17025, but they do not have mutual recognition arrangements in place. Technical Requirements Covered by Calibration Toolbox: - Accommodation and environmental conditions - Test and calibration methods and method validation - Equipment - Measurement traceability - Handling of test and calibration items - Assuring the quality of test and calibration results - Reporting the results For more information, please see our ISO/IEC 17025 page.

21 CFR Part 11

We are often asked how Caliso Calibration Toolbox addresses the issues raised by 21 CFR Part 11. The answer to this is simple: Calibration Toolbox meets all the requirements for software validation and electronic record keeping: FDA compliant Validation Pack available Secure Paradox database Login with user-names and passwords Full audit trail and exception logging 'Calibrated By' field is password protected Calibration and device movement histories Multi-level user access

In addition, Calibration Toolbox provides you with all the tools you need to export your data into programs (such as Adobe Acrobat,and MS Word) that support certificated electronic signatures to standards that are accepted the world over. That way, you can create certificates, reports, in fact anything you need, in full confidence that your compliance is not compromised.

FDA Software Validation

The U.S. Food and Drug Administration (FDA) defines software validation as "confirmation by examination and provision of objective evidence that software specifications conform to user needs and intended uses, and that the particular requirements implemented through the software can be consistently fulfilled". Caliso Calibration Toolbox gives absolute compliance with the FDA requirements for Software Validation which are, quite simply stated, to prove that the software does exactly what you need, accurately and reliably.

GLP - Good Laboratory Practice GMP - Good Manufacturing Practice

The primary objective of GLP is to ensure the generation of high quality data. Essential to this is the ability to produce estimates for the measurement uncertainty associated with calibrations. Caliso Calibration Toolbox enables you to perform all the nesessary analysis in accordance with NIST/GUM guidelines, including Type A and Type B uncertainties, combined uncertainties, coverage factor and expanded uncertainties. Other key GLP/GMP issuses covered by Calibration Toolbox are: Unique ID number to identify each instrument or device Calibration data storage and calibration histories Compliant calibration certificate design Easy access to standard operating procedures (SOPs) Secure Audit Trail

• The most powerful search, locate and reporting tools available in ANY calibration management software
• e-mail facility
• WYSIWYG calibration certificate design
• Measurement Uncertainty calculator
• Multi-Channel, Sphygmomanometer, Pipette, Calendar Van Dusen, ITS-90, Go-NoGo, Standard comparison calibration types
• Regression analysis
• Yearplanner and diary
• Calibration cost analyser

• Evaluate all of the tools and features using read-only demonstration database or
• Create a database of your own ( up to a maximum of 10 devices )