Laboratories electronic record keeping

This inspection disclosed deficient controls in the laboratory electronic record keeping system which is used for maintaining chromatographs and audit trails. [FDA Warning Letter, 2000]... 

SOPs can be paper-based or electronic. The trend toward electronic record-keeping is becoming more common in laboratories. The only requirement made by the inspectorate is that accurate, controlled copies are available on the electronic media and that... 

The documentation of all aspects of a POCT service has been a major issue for many years, compounded by the fact that often the storage of data in laboratory and hospital information systems has been limited and often inconsistent. Thus it is critically important to keep an accurate record of the test request, the result, and the action taken as an absolute minimum. Some of the issues concerning documentation are now being resolved with the advent of the patient electronic record, electronic requesting, and better connectivity of POCT instrumentation to information systems and the patient record (see earlier discussion). The... 

In many laboratories, particularly those in the pharmaceutical industry, government regulations, new product development, product testing, and auditing have led to a substantial increase in paperwork, Because of the extensive use of computers and automated instruments in analytical laboratories, there has been discussion for many years that electronic, paperless laboratories could solve the problems caused by this explosion of paperwork and record keeping. 

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