Transcription of GUIDELINES FOR VALIDATING ELECTRONIC CHART …
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GUIDELINES FOR VALIDATING ELECTRONIC CHART …
IFTPS GUIDELINES VALIDATING ELECTRONIC CHART Recorders Institute For Thermal Processing Specialists GUIDELINES FOR VALIDATING ELECTRONIC CHART . RECORDERS. Various methods may be employed to validate ELECTRONIC CHART and the following recommendations are to be considered voluntary GUIDELINES . While this does not preclude the application of other methods and equipment, these GUIDELINES have been developed by consensus of the Institute For Thermal Processing Specialists and should be given serious consideration for adoption as methodology by individuals VALIDATING ELECTRONIC CHART recorders. SCOPE In 1997, the US Food and Drug Administration (FDA) introduced 21 CFR Part 11 regulation to provide criteria under which the FDA will consider ELECTRONIC records and signatures to be equivalent to paper records and handwritten signatures.
IFTPS Guidelines Validating Electronic Chart Recorders Issue Date: June 1, 2018 2 2.0 OBJECTIVE The purpose of this document is to provide guidance on the validation of electronic chart recorders to
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