If you’re like most people, you resolved to lose weight this year. Eat less; exercise more; lose weight. Simple, right? Yes, but not easy! Computer system validation is like that – there are 4 simple principles behind it. In fact, they’re so simple, I call them Stupid Simple. If you avoid auditing computer systems, listen up!… [Read More…]
1 Sure-Fire Way To Increase Your Value As An Auditor: Get Certified
Why Get Certified? Certification is a way to demonstrate to your current and future employers, your coworkers, and your auditees that you have mastered a defined Body of Knowledge (BOK) through studying, testing, and work experience. You can use your certification to demonstrate increased competency and get promotions and pay raises. A recent survey reported in ASQ’s Quality Progress… [Read More…]
5 Questions You Should Ask Your GLP & GCP Labs (and the answers you need to know)
1. What are the records? Records include more than the final assay results. For example, they can include audit trails, QC results, user access control lists, and configuration settings. Review the manufacturers’ user and administrator manuals to identify records the instruments create, modify, maintain, or transmit. Ask for a guided tour of the validation / qualification… [Read More…]
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