Records, electronic

Iron, trinitrato(dinitrogen tetroxide)-structure, 1,28 Iron, tris(acetylacetone)-electron recording system, 6,127 structure, 1, 65 Iron, tris(bipyridyl)-... 

Naphthol, l-(2-pyridylazo)-hexaamminecobalt(III) complex electron recording system, 6, 127 metallochromic indicators, 1, 546, 556 Naphthols metal complexes color photography, 6, 107... 

Phenanthroline, 4,7-diphenyl-electron recording system, 6,127 liquid-liquid extraction, 1, 544... 

Drug, and Cosmetic Act and the Fair Packaging and Labeling Act. Color additives. Part 11 Electronic Records Electronic Signatures... 

Traditionally, documentation has been maintained on hardcopy paper systems. However, soft copy computer records are permitted provided it can be assured that the records can be maintained without corruption. More sophisticated systems that are used to create electronic records and electronic signature must be capable of... 

FDA Guidance Guidance for Industry Part 11, Electronic Records Electronic... 

Computer systems must provide time-stamped audit trails to record actions that create, modify, or delete electronic records. 

FDA. Code of Federal Regulations, Title 21 Food and Drugs, Part 11 Electronic Records Electronic Signatures Final Rule, Fed Regr 62 (54), 13429-13466 (20 March 1997). 

FDA. Withdrawal of draft guidance for industry on Electronic Records Electronic Signatures, Electronic Copies of Electronic Records, Fed Regr 68 (23), 5645 (4 February 2003). 

FDA. Draft Guidance for Industry on Part 11, Electronic Records Electronic Signatures—Scope and Application Availability of Draft Guidance and Withdrawal of Draft Part 11 Guidance Documents and a Compliance Policy Guide, Fed Regr 68 (37), 8775-6 (25 Eebruary 1997). 

However, adoption of ELNs as a standard tool within corporate research was hampered by both the legal and regulatory requirements of the time. The FDA, the federal courts, and the USPTO were not really aligned to adoption of electronic records for NDA submission or for patent purposes. This was to... 

Subpart B—Electronic Records 11.10 Controls for Closed Systems... 

Signed electronic records shall contain information associated with the signing that clearly indicates the following ... 

Electronic signatures and handwritten signatures executed to electronic records shall be linked to their respective electronic records to ensure that the signatures cannot be excised, copied, or... 

Otherwise transferred to falsify an electronic record by ordinary means. 

Record changes shall not obscure previously recorded information. Such audit trail information shall be retained for a period at least as long as that required for the subject electronic records and shall be available for agency review and copying. 

Demonstrate that audit trails are created and maintained for Date and time of operator entries and actions that create, modify, or delete electronic records (methods, sequences, raw data, results, reports, calibrations, standards, event logs)... 

Signed electronic records Demonstrate that the signed... 

These items are subject to the same controls as for electronic records and shall be included as part of any human readable form of the electronic record (such as electronic display or printout). 

Demonstrate that electronic signatures are linked to their respective electronic records in a manner that prevents excision, copying, modifying, or otherwise transferring to falsify an electronic record by ordinary means (e.g., by opening in WordPad to edit, or by simple file operations). 

Demonstrate that the printed, hand-signed copy has sufficient information to link the report to a unique electronic record (date, time printed, name of person printing report, file name, date/... 

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