Calibration vs Validation:
Calibration:
Calibration is a demonstration that, a particular instrument or device produces results within specified limits by comparisons with those produced by a reference or traceable standard over an appropriate range of measurements.
However, Temperature Calibration comprises thermometers, RTDs and Thermocouples, Dry Block calibrators and Temperature baths. Performance of an instrument or device is comparing against a reference standard, in calibration. Calibration ensures that instrument or measuring devices are able to produce accurate results.
Temperature calibration services accommodate a wide range of instruments in order to meet the precise temperature measurement requirements of our customers. Calibration intends to be performed periodically, to identify the ‘drift’ of the measuring device or equipment and make them accurate.
The advanced high precision calibration facilities include Electronic Standard Cells, Multifunction Transfer Standard, Thermal Transfer Standard, Multifunction Calibrator, AC/DC Current Shunts, RLC Standard, Frequency Standard, Power/ Energy Standard.
Each calibration performed includes detailed calibration report containing measured values, Measurement uncertainty and measurement traceability at each point of measurement. Handheld resistance testers and insulation testers such as the Fluke 1500-series and the Megger MIT400-series can also be calibrated.
Validation:
Validation is an establishing documented program that provides a high degree of assurance that a specific process, equipment, method or system consistently produces a result meeting pre-determined acceptance criterion.
Written plan stating how validation will be conducted and defining acceptance criteria. For instance, the protocol for a manufacturing process identifies processing equipment, critical process parameters/operating ranges, product characteristics, sampling, test data to be collected, number of validations runs, and acceptable test results.
The term ‘Thermal validation’ is the process of validating / qualifying equipment and storage facilities to prove that they will create and maintain the temperatures they are designed for. Validation is an important part of Analytical as well as Bio-Analytical Method.
The procedures involved in checking data or programs for correctness, compliance with standards and conformance with the requirement specifications. Validation shall be performed as per validation protocol. The pharmaceutical industry is a highly regulated environment based on research, evidence, record-keeping and validation.
It is establishing documented evidence, which provides high degree assurance that a specific process will consistently produce a product meeting its predetermined specification and quality characteristics. There are no such reference standards used in the validation program.
Calibration totally differs from Validation But it is an integral part of validation. Validation provides documented evidence that a process, equipment, method or system produces consistent results. It should be performed when changes or modifications happen to the existing system or once revalidation period is reached.
Wired & Wireless types of Validation and Monitoring equipment are major responsibilities comes under thermal validation. Well maintained and calibrated equipment ensures that it operates at peak performance and complies with regulatory requirements.