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

FDA CDER/ORA Compliance Policy Guide 7132a.11Section 425.100 revised 4-Sept-87 “Computerized Drug Processing; CGMP Applicability To Hardware and Software” . Establishes approach to applying Drug GMP to software and specifies software will be treated as records.

SoftwareCPR keywords: software, drugs, pharmaceuticals, validation

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Our cybersecurity experts are NESSUS Pro Licensed and can quickly remediate cybersecurity deficiencies with your medical device or digital health software.  Planning, requirements, validation, and submissions – we can assist with all.

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