©2016 Smartware Group, Inc. All Rights Reserved.

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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

lida

tio

n A

pp

rova

l &

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