By Donald C. Singer
Publication via Singer, Donald C.
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Additional info for A Laboratory Quality Handbook of Best Practices & Relevant Regulations
Not only does it provide a poor impression of the controls, or lack thereof, that are in place, but keep in mind that everyone reacts differently when under the pressure of the audit. The time to document the data was at the time of the operation, and if something was inadvertently omitted it should have been caught at the time of checking and approval. Internal audit programs must not be solely relied upon to uncover all documentation omissions as they only take a “snap shot” of the whole process.
Valid electronic signatures used in a LIMS system ensure development of a compliant, paperless system. The 1998 FDA Guide to Inspections of Computerized Systems in the Food Processing Industry discusses inspection of computerized systems, particularly in the food processing field. This document is a good source for guidance on automated data recording devices, such as thermocouples, resistance temperature devices (RTDs), pressure transducers, etc. The document gives guidance on computerized system hardware, Chapter Six: Sample Control and LIM Systems 41 maintenance and calibration, system software, validation, and system operation.
1 Change in the types of documents and their content detail. Documentation is only as good as the procedures and training that support it. A company needs to have a standard operating procedure (SOP) which describes in suitable detail the writing, issuance, and maintenance of documents. In larger companies there is usually a corporate document (policy) that describes, in general terms, documentation commonly found, but this is usually based on legal, patent, and business requirements. The corporate quality organization may issue a guideline with the general requirements for the standard and content of documentation, which is used in regulatory applications or in regulated industries.
A Laboratory Quality Handbook of Best Practices & Relevant Regulations by Donald C. Singer