"Audit-Proof" Validation

 

HRCare “audit-proof” validation means we stand behind everything we certify.  You have confidence in passing USP, FDA, cGMP, GLP and other international regulatory protocols and audits.  Our comprehensive validation documents provide your management and metrology team with a complete package for easy audit approvals.

In addition to equipment maintenance, HRCare teams execute IQ, OQ, PQ and RQ (installation, operation, performance and re-qualification) protocols in your lab.  At your convenience - according to your timetable.  Our USP-trained chemists run calibrator tests, and ensure that every dissolution tester is primed and ready for workload and performance.

Hanson Q-Paks™ were the first in dissolution to provide functional validation guidelines for USP/FDA compliance and system “IQ/OQ/PQ”. We use Q-Paks and HRCare protocols to fully document our preventive maintenance and system validation programs.  HRCare teams use NIST-traceable calibration tools for critical physical measurements.

 

 

We document, sign and certify everything we do, from preventive maintenance services to instrument performance, qualification and validation.

 

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