GMP-compliant qualification and requalification processes
Manufacturer expertise
Qualification performed directly by the system manufacturer
Standardized documentation
Traceable, audit-ready protocols and reports
Planned downtime
Efficient processes with defined time windows
Lifecycle-oriented
Aligned with operation, maintenance, and requalification
Integrated testing services
Inspections and tests included within the qualification scope
Regulatory acceptance
Documentation serves as a robust basis for audits
Globally consistent
Consistent qualification quality across all sites
Application
Secure qualification for regulated production environments
For the initial qualification of new isolators
We perform the initial qualification for you, including Installation Qualification (IQ), Operational Qualification (OQ), and optionally Performance Qualification (PQ), covering all defined inspection and testing activities.
For the requalification of existing systems
Requalification must be performed at defined intervals to ensure regulatory approval and reliable system operation. This includes both the SKAN isolator and all integrated components.
Process
Structured process for (re-)qualification of SKAN systems
1
Scheduling and scope definition
Joint planning of the qualification scope, definition of requalification intervals, and agreement on the time window for execution.
2
Preparation of qualification documents
Creation of qualification-relevant test protocols, templates, and SOPs according to the defined scope and regulatory requirements.
3
On-site execution
Implementation of (re-)qualification tests at the system, including inspections, functional checks, and integrity tests. Test equipment covers all required tests. Calibration traceability of the calibration devices is ensured.
4
Documentation of results
Complete and traceable recording of all test results in standardized qualification documents.
5
Review and coordination
Joint review of results, assessment of deviations, and definition of potential follow-up actions.
6
Verification and approval
Technical review and release of the qualification documentation for GMP-compliant operation.
Service highlights
Added value through manufacturer-led qualification
Audit-ready documentation
Standardized qualification documentation meets regulatory requirements and reduces risks during audits and inspections.
Efficient requalification
Validated test plans, coordinated workflows, and experienced service teams enable short and predictable downtime.
Technical depth
Direct access to SKAN-specific system knowledge, aligned test equipment, and qualified SOPs for all relevant components.
