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FDA #9

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0xDBFB7 opened this issue Jun 3, 2024 · 0 comments
Open

FDA #9

0xDBFB7 opened this issue Jun 3, 2024 · 0 comments

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@0xDBFB7
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0xDBFB7 commented Jun 3, 2024

https://www.fda.gov/files/drugs/published/Data-Integrity-and-Compliance-With-Current-Good-Manufacturing-Practice-Guidance-for-Industry.pdf

314 It is not acceptable to record data on pieces of paper that will be discarded after the data
315 are transcribed to a permanent laboratory notebook (see §§ 211.100(b), 211.160(a), and
316 211.180(d)). Similarly, it is not acceptable to store data electronically in temporary
317 memory, in a manner that allows for manipulation, before creating a permanent record.
318 Electronic data that are automatically saved into temporary memory do not meet CGMP
319 documentation or retention requirements.
320
321 You may employ a combination of technical and procedural controls to meet CGMP
322 documentation practices for electronic systems. For example, a computer system, such as
323 a Laboratory Information Management System (LIMS) or an Electronic Batch Record
324 (EBR) system, can be designed to automatically save after each separate entry. This
325 would be similar to recording each entry contemporaneously on a paper batch record to
326 satisfy CGMP requirements. The computer system could be combined with a procedure
327 requiring data be entered immediately when generated.

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