Partnerships
Buhl & Bønsøe and QV-Compliance enter into a partnership – complete solution for qualification and validation of climate facilities
The pharmaceutical industry now has one comprehensive partner when it comes to qualification, validation, calibration and specification of climate facilities.
Buhl & Bønsøe and QV-Compliance have entered into a strategic partnership that combines measurement expertise with expert knowledge in compliance. Together, we now offer complete solutions where both technology, documentation, regulatory requirements and project management are handled from start to finish.
One comprehensive solution for climate facilities
Customers get a fully comprehensive solution for qualification and validation of climate facilities.
The process begins with project management, where the entire process is planned and managed so that both technical and regulatory requirements are met in accordance with applicable GMP, GDP, FDA and ISO standards.
From qualification to validation – with full documentation
Once the design is approved and the facility is installed, qualification (IQ/OQ) is performed, where it is documented that the facility is correctly installed and functions as intended under defined conditions.
This is followed by validation (PQ), where the facility’s performance is tested in practice to ensure that it consistently delivers results within the established tolerances.
Sensors and data loggers for mapping temperature and humidity are delivered accredited and calibrated, so that the documentation always stands strong during audits and authority visits.
One overall responsibility – from design to audit
As a part of the Indutrade group, we benefit from a strong international network of several companies who deliver solutions to the pharmaceutical industry. This gives a solid foundation and strengthens our competencies and market understanding in sectors with high demands for quality and documentation.
Technical insight meets compliance
We take responsibility for the entire process:
Accredited calibration » Qualification » Validation » Revalidation/service
This means that you get one point of contact and a comprehensive overview – from the first project proposal to handover, support and maintenance.
The complete autoclave solution
We offer a full, structured process from requirement clarification to a fully installed and documented autoclave solution. The entire process is managed methodically with transparency, traceability and quality in focus.
We prepare all necessary requirements and design documents, perform risk assessments and ensure correct supplier and product match. We handle purchasing and follow-up with the manufacturer, and we conduct a design review so that the solution is fully documented and approved before installation.
Everything is planned and documented according to applicable standards, creating a solid quality foundation for qualification and validation. We concider, among other things:
- Capacity and operating patterns
- Measuring equipment and installation
- Process risks
- Documentation requirements, audit level and data management
- 21 CFR Part 11, traceability and data integrity
What do you get?
An autoclave which is fully controllable, documented and fit into your production.
Autoclave qualification, validation and operational assurance
Once the autoclave is implemented, we take responsibility for qualification, validation and subsequent operational assurance, so the equipment remains stable, safe and in compliance.
We carry out IQ/OQ and PQ based on structured test plans, approved protocols and traceable documentation. All tests are performed with calibrated and accredited measuring equipment.
The results are compiled in audit-ready documentation, which can be used for internal, external and regulatory audits.
Ongoing re-qualification and calibration
After implementation, we offer periodic re-qualification and calibration, so that systems and equipment remain in validated condition and comply with applicable requirements over time. This way, customers can be sure that both technical and regulatory requirements continue to be met, year after year.
Technical insight and compliance in the same solution
With Buhl & Bønsøe as specialists in measurement equipment, mapping and calibration, and QV-Compliance as experts in compliance, qualification, validation and project management, customers get one comprehensive partner who takes responsibility for the entire process, from technical execution to regulatory documentation.
Together we ensure quality and compliance
The collaboration is aimed at companies where the requirements for validation, documentation and climatic protection are high. Here, customers get a solution that combines practical measurement technology, systematic quality assurance and regulatory overview – and thus ensures a solid foundation for both operations and audits.
Read more about how Buhl and Bønsøe helps companies in the pharmaceutical industry with measuring equipment, mapping and calibration.
