|
| | |
|
| |
| | |
|
|
Calibration Toolbox ADO - Calibration Management Software
|
|
Item Number: CalToolBoxADO
Manufacturer: Humpage Technology Ltd.
Part Number: CalToolBoxADO
|
Calibration Toolbox ADO Calibration Management Software
Calibration Toolbox ADO is calibration management software for the most demanding
applications. Used and trusted by scientists and engineers all over the
world for over 10 years, Calibration Toolbox ADO has become the
standard by which all calibration management software is judged.
Calibration Toolbox ADO, sets the bar even higher than before. In our opinion, nothing else comes close.
There is full compliance with the requirements of both 21 CFR Part 11 and FDA validation guidelines.
Calibration Toolbox ADO also totally complies with the requirements of ISO 17025, ISO 9001, GMP and GLP.
You will also find a comprehensive set of tools to help you with
practically all of the jobs required in modern calibration facilities:
- Uses the very latest ADO technology to provide either JET (MS-Access) or MS SQL Server connectivity
- Powerful and configurable database search, locate and reporting tools
- Track calibration jobs from recall to return to user
- E-mail calibration reminders
- WYSIWYG calibration certificate designer
- Measurement Uncertainty calculator
- Regression analysis
- Year planner and diary
- Validation Pack Option for FDA regulated companies
and much more...
Click on View More Imaged above to see Calibration Toolbox screens.
Download Calibration Tool Box PDF Brochure
Need Validation? Calibration Toolbox ADO has you covered...
1. What is the purpose of the Validation Pack ?
If your company is involved, in among others, the healthcare, pharmaceutical and biotechnology industries, its entire
quality control system has to be validated. This encompasses, not only the system as a whole, but also the individual
elements and components that make up the system.
The ultimate responsibility for the validation of your system lies with your company. However, vendors of proprietary
software, such as Calibration Toolbox ADO, can play their part by providing you with validation documentation for
their software, and tools for testing the software in its intended location, i.e. in your company.
Calibration Toolbox ADO, which is widely used throughout the above industries, is designed to automate parts of
your company's quality control system and, because of this, has been subjected to strict validation/verification
procedures. It is classed as "off the shelf" software in which by definition you, the end-user, played no direct part in
the specification, development and testing. One of the key purposes of this document to demonstrate to you and any
inspectorate, that the software has been designed, developed and tested in accordance with the internationally
accepted guidelines for software validation.
2. What are Validation and Verification ?
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".
Quite simply stated, validation proves that the software does exactly what you need.
Software verification, on the other hand, "looks for consistency, completeness and correctness of the software
and its supporting documentation, as it is being developed, and provides support for a subsequent conclusion that
software is validated". In other words verification, which includes software testing, forms part of the validation process.
Again, simply stated, verification proves that the software accurately and consistently carries out the tasks
for which it was designed.
3. What Does this Validation Pack Contain ?
The validation pack is in two volumes which contain:
VOLUME 1 - Validation and Verification Carried out on Calibration Toolbox ADO as part of the Software
Development Process
1. A description of the System Requirements Specification.
2. A description of the Validation Plan including test procedures and specifications used
for the in-house validation of the software
3. A report on the final tests carried out on Calibration Toolbox ADO
Volume 1 demonstrates that Calibration Toolbox ADO was designed and
tested in accordance with internationally accepted software validation principles. A comprehensive system
requirements specification is given and results of key software tests provided.
Also in the documentation a detailed description is provided on how the project of developing Calibration Toolbox ADO
was carried out in terms of change management and verification and integration testing.
VOLUME 2 - End-User Software Validation
1. Guidelines for validation of Calibration Toolbox ADO by the user in its intended location.
This second volume is intended to help you, the Calibration Toolbox ADO user, validate the software in the
location in which you intend to use it. Consider it as a follow on to the documentation in the first
volume (in other words we have done our part we are now going to help you to carry out yours).
This documentation is structured so that you can complete all of the necessary validation tasks as quickly and
efficiently as possible.
|
|
|
|