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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]
Line 44: Line 44:
     * 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
 +
 +
 +
 +== Template: Software Application Risk Assessment ==
 +Header
 +  * //<Company Name/Logo>//
 +  * SW Application Validation
 +  * Version: //<VersionNum>//
 +  * Document Control Number: //<DocNumber>//
 +  * Release
 +    * Created by: Name, Title, Signature, Date
 +    * Reviewed by: Name, Title, Signature, Date
 +    * Released by: Name, Title, Signature, Date
 +
 +Content
 +  * 1 Purpose: //<Content>//
 +  * 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
 +  * //<Company Name/Logo>//
 +  * SW Application Validation
 +  * Version: //<VersionNum>//
 +  * Document Control Number: //<DocNumber>//
 +  * Release
 +    * Created by: Name, Title, Signature, Date
 +    * Reviewed by: Name, Title, Signature, Date
 +    * Released by: Name, Title, Signature, Date
 +
 +Content
 +  * 1 Purpose: //<Content>//
 +  * 2 SW Application: //<AppName>//
 +    * 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
 +
 +