At the HRC, the documentation relating to the quality management system is a multi-tier hierarchy. Falling under the QAP for each study are operating procedures and the use of scientific notebooks. Measurement and Test Equipment Controls Measures are to be established to insure that laboratory equipment such as analytical balances, pH meters, instruments, and other measuring and test equipment used in activities that affect quality are controlled, calibrated, and adjusted properly at specified periods to maintain accuracy within necessary limits. SOPs are to be composed where necessary as specified in individual QA Project Plans for the proper use of these devices. Equipment is to be calibrated against certified standards having known valid traceability to the National Institute of Standards and Technology or to other nationally recognized standards.
Equipment is calibrated, adjusted, and maintained at prescribed intervals.
If no nationally- recognized standards exist, the basis for calibration is documented. Records are maintained indicating calibration status. On a basis at a minimum concurrent with major changes in sponsors' quality systems, management sees that the HRC quality system is formally assessed and the results documented. Management normally uses internal staff to conduct self-assessments. All HRC activities are subject to planned and scheduled internal and external systems and performance audits to assure that procedures and activities comply with the overall QA Program and to determine their effectiveness.