SOCRA Exam Questions With Accurate Answers

Electronic signature are currently accepted for any and all records, paper or electronic form. True or False? - ANSWER-False. The general provisions for electeonic signature criteria apply to records that are i. Created, modified, maintained, archived, retrieved, or transmitted, in electronic form ii. The criteria do not apply to paper records that are or have been transmitted by electronic means. If the electronic records meet the criteria specified in 21 CFR 11, thr agency will consider the electronic signatures, initials, and other general signing equivalent to full handwritten signatures, unless specifically excepted by regulations effective after August 20, 1997. True or False? - ANSWER-True Electronic records cannot be used in lieu of paper records. True or False? - ANSWER-False. Electronic records that meet the requirements may be used in lieu of paper forms, unless paper records are specifically required. provisions are subject to whose inspection? - ANSWER-The FDA's inspection Provided they meet the requirements, persons can use electronic records lieu of paper records, for records required to be maintained, but not submitted to the agency. True or False? - ANSWER-True. Persons can use electronic records in lieu of paper records for documents required to be submitted to the agency provided the document has been identified as a type of submission that the FDA will accept in electronic format. T or F? - ANSWER-True.