Optimize and automate the review process in the laboratory with the CLEAR ToolKit.
Developed by Empower experts to solve data integrity challenges!
CLEAR is the extension to your Empower 3 system that automates and digitizes the second person check and audit trail review.
Replace your paper checklists!
CLEAR is more than the digital replacement of your old paper checklist. CLEAR guides the user through the review process and presents the necessary Empower data for each check point in such a way that a quick and reliable check is possible. No data to search and view filters to build, CLEAR shows what you need to see.
Fully integrated into your existing CDS
But not only the implementation will convince you, the review process itself is also optimized and well thought out. Based on the required “risk-based approach” we examined what information is relevant and what is unimportant. The result is an efficient process that ensures the integrity of the Empower Results without taking up unnecessary time.
Together with our SOP-Box we optimize your work processes!
CLEAR stores all review result in Empower. This means that the documentation of the review is always immediately available. The completion can then be confirmed in Empower by an electronic signature.
Of course, you can call up your CLEAR Review Report again at any time.
The Computized Look-Over Examination and Recording (CLEAR) ToolKit app is launched from a selected Empower project.
1. The Result Set ID for the review is entered in CLEAR and the CLEAR process is started.
2. The reviewer is guided through the process by CLEAR.
3. If the system does not detect any deviation from the CLEAR specifications, the step is automatically marked as “Passed”.
4. If steps are accepted or rejected manually by the reviewer, it must always be entered a comment. The comment is saved in Empower and can be read out by the report.
5. After all steps have been completed, the Report Publisher is opened, in which the reviewer can open the release and/or sign-off report and carry out the sign-off level 2 including the channel lock.
Your Advantages & Possibilities
- Start CLEAR directly from Empower. As a toolkit app, CLEAR is fully integrated into Empower.
- No administrative effort is necessary, since the Empower user administration is taken over by CLEAR.
- CLEAR was developed for the pharmaceutical laboratory and meets regulatory requirements.
- CLEAR optimally prepares the data to be reviewed and ensures an integral and efficient review.
- CLEAR guides the user step-by-step through the defined review process. This avoids all errors and speeds up the review.
- The data integrity of your analysis is thus ensured.
- The many years of experience in supporting Empower installations and the deep knowledge of data integrity requirements have gone into the development of CLEAR. This resulted in a product that makes the review process extremely effective and compliant.
- CLEAR ensures a paperless review, saving you time and resources in documentation.
- Go confidently into every audit with CLEAR.