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发表于 2019-9-25 16:08:17
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PDA Technical Report No. 80
Data Integrity Management System for Pharmaceutical Laboratories
6.3.2.1 Controls for COTS Software for HPLC, GC, and Other Instrument Operations
The following are the minimal controls needed to safeguard COTS software and secure its use:
• Identifying the person(s) responsible for installing updates
• Addressing any changes to software through change control procedure with risk assessment
• Setting up secure individual user log-ins and periodic change of passwords
• Disabling data modification, deletion, or copying by anyone other than the administrator
• Restricting data deletion to only the authorized system administrator following established procedures,
with oversight by the Quality Unit
• Maintaining a detailed, QA-approved list of roles and responsibilities and copies of previous versions
of software when updating to allow reviewing, processing, audit trail review, backup/restore testing,
and reporting of older reports in case of regulatory requirements and investigations (recommended)
• Establishing periodic review of control effectiveness based on the risk posed, paying attention to
software upgrades and patches, and taking appropriate remediation and/or mitigation actions
• Maintaining a detailed list of roles, responsibilities, and access privileges for all the software in the laboratory |
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