Laboratory automation notes

The quality and integrity of the raw data should be strictly controlled and guaranteed. Raw data are any laboratory worksheets, records, memoranda, printed and handwritten notes, photographs, microfiche copies, computer printouts, magnetic media, dictated observations, recorded data from automated instruments, or exact copies that are the result of original observations and activities of a study. Overall, the term raw data covers all data necessary for reconstruction of the report of the study. 

Note The instruments used in the laboratories vary significantly in the design and operation complexity. The validation requirements should reflect the level of complexity of the instrument. It is obvious that the amount of effort required to validate a simple pH meter will be different from that required for a fully automated dissolution system. The Good Automated Manufacturing Practice (GAMP)... 

Note Data may include computer printouts, magnetic media, and recorded data from automated instruments that are the result of the original observations, and activities of a non-clinical laboratory study necessary for the reconstruction and evaluation of the study report (electronic copies of electronic record files can be considered electronic record files provided that the data transfer processes have been verified). 

The way in which the changes have affected a well equipped R D laboratory situated in the Plastics Division of I.C.I. is shown in Fig. 1. This demonstrates the impact of instrumentation on sample throughput. It is interesting to note however that the growth has not been linear. The period of rapid improvement in efficiency coincided with the time when mechanical forms of semi-automation, which were easy to develop, install, operate and maintain were in vogue. With the introduction of more sophisticated instrumentation, the per capita output has levelled off, but the complexity of the analysis has increased For example, with 13C NMR as well as XH NMR it is possible to make structural assignments to polymer chains routinely. 

It is now common practice in our laboratory to assay parathyroid hormone by a fully automated system in batches of 60 samples with appropriate controls at intervals of 20 samples. Patient samples are input at the appropriate dilution, this process taking approximately 1 hr. On the reagent addition unit, labeled antibody is added, as well as plasma to standards and buffer to plasma samples. Reagent addition takes 10-15 min. After incubation at 4 for 72 hr, the assay tubes are allowed to adjust to room temperature (the Kemtek 3000 does not have means of refrigeration), and immunoadsorbent is added, with a 10 sec delay between each addition. When addition is complete (30-40 min), filtration is commenced with a cycle that takes 50 sec for its five simultaneous transfers plus washing. The filters are dried and counted. It should be noted that this procedure differs from the standard immunoradiometric technique in that it is the radioactivity not bound to antigen that is counted. The data therefore resemble those derived from a classical radioimmunoassay and can be processed by the Kemtek computer using a polynomial cubic analysis. ... 

Source documents (and the data contained therein) comprise the following types of documents patient files (medical notes where summaries of physical examination findings, details of medical history, concurrent medications/devices and diseases are noted), recordings from automated instruments, traces (e.g. ECGs, EEGs), X-ray films, laboratory notes and computer databases (e.g. psychological tests requiring direct entry by patient onto computers or direct entry of patient information onto computers by physicians). 

All records or certified copies of original observations, clinical findings or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial. Such material includes laboratory notes, memoranda, calculations and documents, as well as all records of data from automated instruments or exact, verified copies, e.g. in the form of photocopies or microfiches. Raw data can also include photographic negatives, microfilm, magnetic media (e.g. computer diskettes) and optical media (CD-ROMs). 

Most laboratory managers will have an intuitive sense of which problems need attention. Nevertheless, it is a good idea to solicit feedback from other members of the laboratory, if for no other reason than to give people at all levels in the organization a common understanding of what is needed. It is recommended to document this problem statement so that it will be clear in the future what the goal is. Note that at this point it is not necessarily an automation project it is only a problem statement. In the... 

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