Is your instrument compliant after every repair?

Regulated laboratories must be able to demonstrate the suitability of analytical instruments during audits and inspections. Performing analytical instrument qualification is the best way of doing this. USP <1058> provides the essential framework for satisfying qualification requirements. When a qualified instrument is repaired, it needs to be re-qualified, before it is used. Therefore, to remain compliant, systems must be re-qualified after repair and repair qualification is an essential component of instrument compliance.

 Agilent has developed and validated RQ services that integrate and map instrument repairs against qualification work requirements for HPLC and GC systems. So, for example, if pump seals are changed on an HPLC system, full system qualification is not required. Instead, pump flow accuracy and precision measurements are the only RQ tests required. The Agilent RQ test matrix is designed into the validated Agilent Automated Compliance Engine (ACE) software, so compliance engineers select repairs from the pull-down menu, and ACE automatically includes the required RQ tests.

 Agilent RQ Services Provide

• Assured Compliance
• Consistent Qualification (Between OQ and RQ)
• Different RQ Test Plans (to Suit Customer Needs)
• Faster Return to Use (After Instrument Repair)
• Reduced Audit Risk (Peace of Mind)

Download Flyer and Pharmaceutical Manufacturing Company case study