Mandatory information to be present in worksheets used in calibration of the Regulatory Laboratory.
It is mandatory that every successful regulatory compliant laboratory will have in-built efficient calibration management system which effectively monitors the calibration status of the every equipment under the laboratory.
Every work sheet used in calibration should provide essential details which include:
- A clear calibration methodology of the equipment.
- If in calibration any Standards were used then Traceability and validity statement is enclosed.
- Equipment information such as type, model, purchase date, manufacturer.
- The person who calibrated the instrument.
- Laboratory should have details of present and previous calibration data for every instrument under usage
- Every calibration should have Date of calibration and calibration due date.
- Unique ID number to identify each instrument or device.
- SOP and Format number used in the worksheet and Annexures.
Supporting Data to be maintained in Regulatory Laboratory:
- Records and reports of the maintenance and calibration of equipment.
- Equipments Qualification which includes IQ/OQ and PQ.
- Summary of qualifications, training, experience of personnel and equipment used.
- Standard Operating Procedures for operating and calibration of equipments. (updated on 28.09.2020)