Validation is a documented program that particular Instrument or device produces provides high degree of assurance that a results with in specified limits by specific process, equipment, method or comparisons with those produced by a system consistently produces a result reference or traceable standard over an meeting pre-determined acceptance appropriate range of measurements. criteria.
Validation provides documented evidence
Calibration ensures that instrument or that a process, equipment, method or measuring devices producing accurate system produces consistent results (in results. other words, it ensures that uniforms batches are produced). In calibration performance of an instrument or device is comparing against a reference standard. No such reference standards are using in validation program.
No such requirements. Shall be performed
Shall be performed periodically, to identify when changes or modifications happen to the ‘drift’ of the measuring device or the existing system or once revalidation equipment and make them accurate. period is reached. Shall be performed as per validation Shall be performed as per calibration SOP. protocol.