IslandFish
Beginner
Posts: 6
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If original records and data have been backed up by a PDF copy, is it ok to dispose of the hard copy "original" since the original is now reprodubile? Or should the original data still be maintained as indicated in 21CFR58.190?
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Kevin at Sanyo
Beginner
Posts: 40
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In response to IslandFish
The originals should be archived until regulatory compliance standards and company SOPs have been met. A copy, while useful, is still not seen as a valid original. Thus the term copy.
Kevin Loomis
Validation Engineer
Sanyo Biomedical Solutions
(630) 694-8218
(800) 858-8442 x8218
kloomis@sss.sanyo.com |
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complianceguru
Beginner
Posts: 23
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In response to IslandFish
Great question! All original raw data and documentation shall be maintained for the period required in the applicable predicate rules. Scanned in versions of the documentation is good to have has a back up copy of the data in case the original is lost - Especially if you are storing data at a third party site.
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