TABLE OF CONTENTS Retention of records is important, as this is a requirement under existing GXP predicate rules written when paper was king. The lifetime of the electronic records generated by a CDS usually outlives the system that generated them. Records retention is the biggest problem facing any computerised system.
58.195(b)14:
Except as provided in paragraph (c) of this section, documentation records, raw data and specimens pertaining to a non-clinical laboratory study and required to be made by this part shall be retained in the archive(s) for whichever of the following periods is the shortest:
A period of at least 2 years following the date on which an application for a research or marketing permit, in support of which the results of the non-clinical laboratory study were submitted, is approved by the FDA. This requirement does not apply to studies supporting investigational new drug (IND) applications for investigational device exemptions (IDE) or applications for investigational device exemptions (IDE), records of which shall be governed by the provisions of paragraph (b)(2) of this section.
A period of at least 5 years following the date of which the results of the non-clinical laboratory study are submitted to the FDA in support of an application for a research or marketing permit.
In other situations (e.g. where the non-clinical laboratory study does not result in the submission of the study in support of an application for a research or marketing permit), a period of at...
