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| Both sides previous revision Previous revision Next revision | Previous revision | ||
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swdev:iso:validation_template [2018/02/27 11:26] smayr [Verification vs. Validation] |
swdev:iso:validation_template [2018/03/01 12:19] (current) smayr [Template: Software Application Validation] |
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| * Specification: | * Specification: | ||
| * Needs & goals of stakeholders. | * Needs & goals of stakeholders. | ||
| - | * Defined as functionality. | + | * Inputs, outputs, |
| - | * Process Parameters. | + | |
| - | * Desired Output. | + | |
| * Regulations. | * Regulations. | ||
| * Decide on verification and/or validation. | * Decide on verification and/or validation. | ||
| Line 35: | Line 33: | ||
| * Control the process continuously. | * Control the process continuously. | ||
| * Revalidate process as appropriate. | * 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 | ||
| + | * //< | ||
| + | * 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 | ||
| + | |||
| + | |||