Differences

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

--- swdev:iso:validation_template [2018/02/27 11:20]
smayr [Verification vs. Validation]
+++ swdev:iso:validation_template [2018/03/01 12:19] (current)
smayr [Template: Software Application Validation]
@@ Line 2: / Line 2: @@
 == Verification vs. Validation ==
-Verification (internal process)
+With verification and validation, we aim to develop a “level of confidence” that the software or device meets all requirements and user expectations.
+**Verification** (internal process)
   * Automated testing, static/dynamic analysis, code inspection, walkthroughs, etc.
   * Checks for regulations, specifications, imposed conditions.
   * Building product right?
-Validation (often external process)
+**Validation** (often external process)
-  * Assurance software meets operational needs of customer or stakeholders.
+  * Assurance software meets operational needs of customer or stakeholders. Confirmation by examination and objective evidence that requirements are consistently fulfilled. Comprehensive testing, inspections, analyses, simulation, etc.
   * Acceptance, suitability.
   * Building right product?
@@ Line 19: / Line 21: @@
     * Specification: a document that states requirements. It might include: drawings, patterns, documents, etc.
     * Needs & goals of stakeholders.
-    * Defined as functionality.
+    * Inputs, outputs, functionality, performance, external/internal/user interfaces, user interactions, error and handling, response times, operating environment (OS, hardware, etc.), ranges/limits/defaults/specific values, safety requirements.
-    * Process Parameters.
-    * Desired Output.
   * Regulations.
   * Decide on verification and/or validation.
@@ Line 33: / Line 33: @@
   * Control the process continuously.
   * Revalidate process as appropriate.
+== What Software Needs Validation? ==
+=== Software To Validate ===
+If a software application has a critical impact on the quality of the product or service delivered to the end-user, and if the use of such software application has a risk associated with it, then such software application shall be validated in accordance with chapter 4.1.6 of the ISO 13485:2016.
+=== Software Not Validated ===
+There are some software programs and tools, that will not be validated as rule, because the software or tools do not do any calculation of process steps themselves. These include but are not limited to:
+    * Any tool or document created using Microsoft Word
+    * 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