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the enduring assets of a laboratories work are the records that document those activities when the laboratory records are used to support a regulatory function they are considered to be legal documents for records to be considered reliable and trustworthy they must comply with the following criteria legible and understandable they must be able to be read and understood for the lifetime of the record without having to refer to the originator for clarification the information may be needed in five 10 or 20 years time perhaps after the originator is no longer available attributable who made the record or created the data and when contemporaneous the record must be made at the time the activity was performed original the information must not be written on a posted piece of scrap paper sleeve of a lab coat etc and then transcribed accurate no errors or editing without documented amendments complete all the information and data associated with the analysis is included consistent all elements in the sequence of analysis must be date and time-stamped and must be in the expected order indelible records are made on two controlled documents such as laboratory notebooks or controlled worksheets or saved to electronic media available over the entire lifetime of the record for review audit and inspection