Category

News
04
Sep

I/O Checks FDA CDER/ORA CPG 7132a.07 Monitoring

September 4, 1987
/Docs/7132a-425-400.PDF
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04
Sep

FDA CDER/ORA CPG 7132a.11 Software as Records

September 4, 1987
/Docs/7132a-425-100.pdf
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01
Jul

FDA Technical Reference on Software Development

July 1, 1987
/docs/fdaswtechnicalreference1987.pdf
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16
Apr

FDA CDER/ORA CPG 7132a.15 Source Code

April 16, 1987
/Docs/7132a-425-300.PDF
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16
Apr

FDA CDER/ORA CPG 7132a.08 Computerized ID

April 16, 1987
/Docs/7132a-425-500.PDF
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30
Mar

MIL-STD-882B System Safety Program Requirements

March 30, 1984
/docs/militarystandard-safety.PDF
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01
Feb

FDA CDER Inspection of Computer Systems

February 1, 1983
/Docs/FDAdrugswguidanceFeb1983.pdf
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01
Mar

Cl II Simens syngo Dynamics PACS

March 1, 1970
Company: Siemens Medical Solutions USA, Inc. Date of Enforcement Report:3/26/2014 Class lI: PRODUCT syngo Dynamics Picture Archiving and Communication System (PACS). Model numbers 10091804, 10091805, 10091806, 10091807, 10091673 Recall Number Z-1216-2014 REASON Potential patient data mixup. Improper error handling could allow for two different patients to be displayed in syngo Dynamics. Images shown for one...
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