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swdev:iso:validation_template [2018/03/01 10:25] smayr [Validation] |
swdev:iso:validation_template [2018/03/01 12:19] (current) smayr [Template: Software Application Validation] |
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* Any tool or document created using Microsoft Word | * Any tool or document created using Microsoft Word | ||
* Any tool or document created using PowerPoint | * Any tool or document created using PowerPoint | ||
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+ | |||
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+ | == Template: Software Application Risk Assessment == | ||
+ | Header | ||
+ | * //< | ||
+ | * SW Application Validation | ||
+ | * Version: //< | ||
+ | * Document Control Number: //< | ||
+ | * Release | ||
+ | * Created by: Name, Title, Signature, Date | ||
+ | * Reviewed by: Name, Title, Signature, Date | ||
+ | * Released by: Name, Title, Signature, Date | ||
+ | |||
+ | Content | ||
+ | * 1 Purpose: //< | ||
+ | * 2 SW Application and Risk Assessment | ||
+ | * Process | ||
+ | * SW Application Name | ||
+ | * Version | ||
+ | * Risk Assessment | ||
+ | * Validation Required? Yes/No | ||
+ | * 3 Approval and Signature | ||
+ | * Place/Date, Name/Title | ||
+ | * 4 Document History | ||
+ | * Version | ||
+ | * Main Changes | ||
+ | |||
+ | == Template: Software Application Validation == | ||
+ | |||
+ | Header | ||
+ | * //< | ||
+ | * SW Application Validation | ||
+ | * Version: //< | ||
+ | * Document Control Number: //< | ||
+ | * Release | ||
+ | * Created by: Name, Title, Signature, Date | ||
+ | * Reviewed by: Name, Title, Signature, Date | ||
+ | * Released by: Name, Title, Signature, Date | ||
+ | |||
+ | Content | ||
+ | * 1 Purpose: //< | ||
+ | * 2 SW Application: | ||
+ | * Risk Identified | ||
+ | * Validation Protocol | ||
+ | * Validate Date | ||
+ | * Validation Outcome | ||
+ | * Validation Document | ||
+ | * 2.1 Validation Conclusion: | ||
+ | * 2.2 SW Application Approved? Approved / Not Approved | ||
+ | * 3 Approval and Signature: Place, Date, Name, Title | ||
+ | * 4 Document History | ||
+ | * Version | ||
+ | * Main Changes | ||
+ | |||
+ |