By Donald C. Singer
Publication by way of Singer, Donald C.
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Additional info for A Laboratory Quality Handbook of Best Practices & Relevant Regulations
Manual data entry may be verified in a number of ways, such as double entry, blind rekeying of data, or other proven method. Data should be verified periodically, even after successful validation. The FDA in 21 CFR 11 states, “Record changes shall not obscure previously recorded information. ” When raw data is changed, the original data or observation needs to be preserved, along with the reason for the change, the person who made the change, and the date of the change. The person authorizing the change, if applicable, should also be recorded.
Review the system hardware, including networking and peripheral devices. Determine software used. Review the documentation, including manuals and standard operating procedures. Review personnel for credentials and training. Review the critical software for validation, including function, inputs, outputs, set points, and data manipulation. Determine how the software was developed, in-house, contractor, or off-the-shelf. Review the software security. Determine if the system has accurate records, adequate calibration and accuracy, and that the personnel are trained in operation of the system.
The database and storage media must be as tamperproof as possible. Procedures must 42 Part II: Critical Laboratory Operations be in place for insuring the validity of the data and a description of consideration for raw data (hardcopy, printouts, or magnetic or optical media). ” Also, LIMS raw data storage media is defined as “The media to which LIMS raw data are first recorded. Media may be paper, microfiche, microfilm, or magnetic or optical storage media. ” The FDA states in the Guide to Inspections of Computerized Systems in the Food Processing Industry (1998) that “electronic records must be maintained in a format that can be presented to the investigator in a readable form.
A Laboratory Quality Handbook of Best Practices & Relevant Regulations by Donald C. Singer