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By Donald C. Singer

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Extra resources for A Laboratory Quality Handbook of Best Practices & Relevant Regulations

Sample text

The original entry of the data is the raw data and there is only one entry of raw data. This is equally applicable to the electronic capture of data from equipment and the recording of data and information by pen onto paper. It may be captured directly from 34 Part II: Critical Laboratory Operations the analytical instruments into a validated management computer system, for example, Laboratory Information Management System. Interpretation of the requirements of the regulations for electronic records and electronic signatures (21 CFR 11) is outside the scope of this chapter.

The amount of data collected for interpretation and statistical analysis has increased many times. Conventional calculators are still used but the sheer volume of data requires computers to handle the data before being processed. Traceability, integrity, audit trails, and identification of analysts are required with a computer, as they were with a pen and paper. Regulatory expectations continue to deal with ever-changing electronic advances. Be honest and hide nothing. Do not intentionally misrepresent information or data.

Interpretation of the requirements of the regulations for electronic records and electronic signatures (21 CFR 11) is outside the scope of this chapter. It is recommended that the reader obtain the regulations and preamble for interpretation by an expert for their company. Each page of data/information must be signed and dated by the analyst and by another person who checks the data for completeness and correctness. If the data is patentable, then a witness not directly involved in the project, but who is competent to understand the meaning of the work, should also sign the page.

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