Adapted equipment qualification with full consideration of regulatory aspects.
Customized and harmonized.
Compared to most instrument qualification solutions, beyontics CIQ is most responsive to laboratory workflow by providing uniform test procedures instead of qualifying instruments with different manufacturers’ tests and procedures.
Full integration with your existing CDS.
beyontics CIQ is implemented as an Empower Project and is equipped with customizable methods and reports. All data and results are stored in your CDS. This also provides full access to metadata generated during qualification. Test failures are output in the CDS for each individual test point and for the entire qualification.
Easy to use. No further validation effort.
Since beyontics CIQ is delivered as an Empower Project, the product can be easily installed using the existing procedures for your CDS. The entire product design is based on the proprietary functions of your CDS. The customizations are delivered in a validated state.
beyontics CIQ – 100% compliance with your requirements.
The scope of the test points and the defined limit values can be defined to meet your requirements: Only relevant device parts are also checked!
Save time and resources.
Minimize the downtime of your devices.
Fully automated test procedures.
beyontics CIQ for Empower is designed to require a minimum of effort to perform the qualification runs. Templates are provided for all tests, so a run only needs to be started and is evaluated in its entirety upon completion. A report can be generated using the options available in the CDS. The use of external evaluation programs is completely eliminated. Qualification runs for several devices at the same time are conceivable.
Reduce training effort for service personnel.
beyontics CIQ is characterized by a high degree of automation, which is why only basic application training for the CDS used is required. Furthermore, a step-by-step user manual is provided, which describes the complete qualification process. Training and instruction are provided by beyontics.
beyontics CIQ from a regulatory perspective.
Safe and traceable.
The following considerations must be taken into account when an external service technician performs a device qualification using proprietary, manufacturer-specific software and hardware:
- Does the software use comply with the guidelines according to 21 CFR 11?
- Are the computer hardware and software used for qualification qualified to the extent that it meets customer standards?
- How to provide raw electronic data in a visually readable form during an inspection
For this purpose, a qualified installation of the software that the technician had used during the equipment qualification is required. Do you want to purchase this software and ensure a qualified state just so they can show this data during an audit?
beyontics CIQ for Empower is the simplest answer to your regulatory requirements.
Many customers who need to pass an audit say “no.” They prefer the device qualification to be performed in the in-house CDS installation. However, this requires implementing appropriate methods and validated reports. Furthermore, you need trained service personnel. This is already covered by the beyontics CIQ.
CIQ in a nutshell
- Empower project for device qualification, adapted to your specifications
- Application for GC and LC
- Control of the qualification process mainly via Empower
- Qualification automation
- Documentation of the entire qualification in Empower
- Manual input of external, physical measured values (e.g., flow rate, temperature)
- Evaluation of the qualification result by Empower
- automated report generation
- Possibility of paperless qualification in connection with the Empower sign-off function
- available for each CDS release booth
IYour advantages & opportunities
- Unified qualification for all devices controlled via Empower
- Storage of raw data in Empower
- Checking the raw data in Empower
- Increased efficiency through automation of qualification
- Shorter downtimes of your devices
- Adaptation of the CIQ project to your individual requirements
- Creation of custom fields
- Support of the project during implementation, if necessary, with the implementing service partner
- Preparation of validation documents and documentation according to customer specifications
- Ongoing support for the productive project