02 — Analytics
Qualification & CSV
When analytics must work reliably and be documented
LabSupport supports analytical systems throughout their entire life cycle.
Agilent Authorized Service Provider · trained by Agilent and Horiba
Our services range from the qualification of your instruments and the validation of computerised laboratory systems to consulting on all aspects of GMP.
Regulatory affairs
Qualification, CSV & consulting
Documentation that stands up to audits and regulatory inspections.
In the pharmaceutical industry, in-process controls and release testing place the highest demands on analytics, instrument condition and documentation. New analytical systems and laboratory software must therefore not only work technically but also be demonstrably fit for their intended purpose.
Drawing on many years of experience in GMP laboratories, we support you in an advisory capacity or take over the operational execution. Our focus is on chromatography (HPLC, GC) and elemental analysis (ICP-MS, ICP-OES, AAS) – as well as on instruments for pharmaceutical (galenic) testing such as dissolution, disintegration and particle testers.
Qualification Analytical instruments & equipment
- Qualification according to USP <1058> and EU-GMP Annex 15
- Preparation and execution of DQ, IQ, OQ and PQ
- Requalification after repair, relocation or modification
- Instrument systems from various manufacturers
Computer System Validation CSV
- Validation of laboratory software and data systems, e.g. chromatography data systems
- Risk-based approach according to GAMP 5
- Implementation of 21 CFR Part 11 and EU-GMP Annex 11
- Assessment and assurance of data integrity (ALCOA+)
- Periodic review and change control
Our approach Consulting & execution
- Enquiry and alignment – we clarify the scope, systems and your internal requirements.
- Concept – risk assessment and qualification or validation plan, aligned with your QM system.
- Execution – tests and checks on site, using your templates or ours.
- Documentation – traceable reports, ready for approval by your quality assurance.
From a single source
Service and qualification, without a second service provider.
After an intervention, we take care of the requalification as well – you only need to coordinate with one team.
