Differences

This shows you the differences between two versions of the page.

Link to this comparison view

Both sides previous revision Previous revision
Next revision
Previous revision
swdev:iso:validation_template [2018/03/01 10:49]
smayr [Template: Software Application 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 == == Template: Software Application Validation ==
  
 Header Header
-  * Company Name/Logo+  * //<Company Name/Logo>//
   * SW Application Validation   * SW Application Validation
-  * Version +  * Version: //<VersionNum>// 
-  * Document Control Number+  * Document Control Number: //<DocNumber>//
   * Release   * Release
     * Created by: Name, Title, Signature, Date     * Created by: Name, Title, Signature, Date
Line 58: Line 85:
  
 Content Content
-  * 1 Purpose+  * 1 Purpose: //<Content>//
   * 2 SW Application: //<AppName>//   * 2 SW Application: //<AppName>//
     * Risk Identified     * Risk Identified
Line 65: Line 92:
     * Validation Outcome     * Validation Outcome
     * Validation Document     * Validation Document
-  * 2.1 Validation Conclusion +  * 2.1 Validation Conclusion 
-  * 2.2 SW Application Approved?+  * 2.2 SW Application Approved? Approved / Not Approved
   * 3 Approval and Signature: Place, Date, Name, Title   * 3 Approval and Signature: Place, Date, Name, Title
   * 4 Document History   * 4 Document History
     * Version     * Version
     * Main Changes     * Main Changes
 +
 +