Write a timeline and summary of the regulations that govern the collection, storage, and release of information kept in an electronic format.

Consider the differences between paper records and electronic records, and explain why there is a need for more stringent rules for electronic records.

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20-07-2024
Computers and Technology

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Write a timeline and summary of the regulations that govern the collection, storage, and release of information kept in an electronic format.

Consider the differences between paper records and electronic records, and explain why there is a need for more stringent rules for electronic records.

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GinnyAnsweridn GinnyAnsweridn · Answer 1 · 2024-07-20T15:48:52-04:00

Final answer:

Regulations have evolved to encourage modern electronic methods while ensuring security and reliability.

Explanation:

Electronic Documentation Regulations Timeline:

1997: FDA issues regulation 21 CFR Part 11 Electronic Signatures; Final Rule.
2003: FDA releases Guidance for Industry Part 11, Electronic Records; Electronic Signatures Scope and Application.

Summary: Regulations governing electronic information gathering and documentation have evolved to encourage modern electronic methods while ensuring security and reliability. The transition from paper to digital documentation has faced challenges due to concerns about data storage and security.

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