Gxp regulatory requirements
[DOC File]USER REQUIREMENTS TEMPLATE - PHARM COMMUNITY
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3.0 Operational Requirements 5. 3.1 Commodities 5. 3.2 Performance 6. 3.3 Functions 6. 3.4 Power Failure and Recovery 8. 3.5 Emergency Stop 8. 3.6 Alarms and Warnings 10. 3.7 Data & Security 11. …
[DOCX File]Home - Pharma Beginners
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Regulatory approval or effect Specification (material sampling & handling sheet) ... Resource adequacy in terns of human resources and infrastructure requirements. ... Change in GxP category 3, 4, 5 …
[DOC File]Requirements Specification - Pace
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Specify the requirements derived from existing standards, policies, regulations, or laws (e.g., report format, data naming, accounting procedures, audit tracing). For example, this could specify the requirement for software to trace processing activity. Such traces are needed for some applications to meet minimum regulatory …
[DOC File]Jobs Posted through July 4, 2008 - Audrey' s Network
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-Maintain good working relationships and communication with GCP QA customers including Clinical Development, Regulatory Affairs and company GXP QA staff. Regulatory Affairs Programs Mgr / Sr. Reg Affairs Programs Mgr_____Colorado Requirements…
[DOC File]ProPharma Group | Regulatory Affairs, Life Science ...
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GxP column - Y/N or X column to recognize whether the requirement is an FDA regulatory requirement (required by predicate rule) Priority Column - can be used for Must Have, Important, Nice to Have or other means of prioritizing requirements for bid/implementation purposes. Physical Requirements
[DOC File]SOP 1
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2. Regulatory and contractual requirements 1. 3. General HHW training program requirements 1. 4. DOT training requirements 2. 5. Haz-cat training requirements 3. 6. Health and safety training requirements …
[DOC File]Standard Operating Proecedure - Meta-X
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A computer system consists of computer hardware, software, operating environment, associated data, and documentation to perform a GXP or regulatory submission function. Policy Computer systems that manage data, support regulatory …
[DOCX File]System Design Document Template - CMS
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Using the Performance Requirements defined in the Requirements Document, provide a detailed explanation that describes how the Performance Requirements were incorporated into the system’s design. Please refer to Sections 2.0 of the CMS Performance Test Plan and Results Template for guidance on defining Performance Requirements.
[DOC File]Transfusion Guidelines
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A review signature verifies that, as a competent reviewer, it is considered that the content of this document is sufficient to meet the regulatory guidelines on validation and GXP requirements. Approved by: An approval signature indicates that the content of this document is sufficient to meet the regulatory guidelines on validation and GXP.
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