Post on 24-Jan-2018
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Taking the Mystery
Out of CMMS
Validation
©2016 Smartware Group, Inc. All Rights Reserved.
For organizations in regulated industries, it’s important to ensure software deployments, including CMMS, are validated appropriately in order to be compliant with all relevant rules.
Typical regulations include:• International Organization for Standardization
(ISO) Certification• FDA
• 21 CFR Part 820 (i)• 21 CFR Part 11
• HIPAA• SOX
Organizations must ensure that they possess the proper documentation depicting how actual system installation, configuration, and usage is in line with these standards.
What does an effective CMMS validation process actually entail?
Let’s investigate!
PLANNING
1
CMMS Validation Process
PLANNING1
The CMMS validation process should begin with a well though-out plan. The plan should outline everything that will occur throughout the project, define the requirements, and include a network diagram depicting all of the interactions involving the software.
ANALYSIS
2
CMMS Validation Process
ANALYSIS2
Once your plan is finalized, you can proceed to compliance analysis, determining which industry regulations apply to the CMMS. All related records, including those that were previously paper-based or housed within homegrown systems, should be a part of the analysis.
TESTING
3
CMMS Validation Process
TESTING3
After proper analysis, you must definerequirements and conduct testing to ensure the software is working as expected and will pass the formal approval process.
VALIDATION
4
CMMS Validation Process
VALIDATION4
The final step in the CMMS validation process is to write a final report that summarizes all tests and defines how the system will be controlled in production, perform any necessary training, define user procedures, and document accordingly.
VALIDATION4
Typical validation documentation includes:Software
Validation
Protocol (SVP)
Project Plan
Software
Requirements
Specification
(SRS)
System Network
Diagram
Attachment A
Safety Analysis
Part 11
Compliance
Analysis
Software
Verification and
Validation Report
(SVVR)
Tester Training
Record
Attachment A
Business Process
Procedures
(Quality)
Software
Verification
Protocol
(Test Plan)
Test Specifications
(Test Cases)
Requirements
Traceability Matrix
Executed Test
Scripts
Attachment B
Va
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tio
n A
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T
estin
g
What if I already have a CMMS in place?
The CMMS validation process for existing systems is nearly identical, except retrospective in nature. A pre-project analysis should be conducted by your CMMS provider to determine if the software is being used correctly and if optimal processes are in place before validation.
Whether you validate CMMS during implementation or after, it’s important to thoroughly review all software updates
to determine the need to re-run test cases, refresh relevant documentation, or re-validate the software.
TIP: Check your CMMS provider’s release notes to better understand what features were changed.
Sound daunting? Navigating CMMS validation doesn’t have to be an overwhelming project.
Preferred Partners can work with your teams and system provider to manage the project entirely and can even offer a train-the-trainer approach.
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Continue your investigation
Discover Preferred Bigfoot Validation Partner, Penny Goss Technical Solutions:
http://www.bigfootcmms.com/company/partners/#PreferredValidationPartner