Assessing the Options for Validated CMMS Software

Deciding which software to use for your calibration, maintenance, or validation program can be daunting.  There are many options available, and each has its benefits and tradeoffs.  Choices run from custom coded, to configurable software, to off-the-shelf, and qualified SaaS (Software as a Service) options available by subscription, on the web.  However the large of a variety of options, an analysis can be applied to each to determine how they best fit your situation.  We hope the following worksheet may be helpful in assessing your various options.  The worksheet intends to consider the short and long-term effects of choosing software to work toward a number that can be used to compare various choices.  Of course, your assumptions about many of the open items are a key to the overall assessment as well as how you weigh the relative requirements.  If you feel this is a useful guide, please contact us for more information and we can provide an electronic copy that you may find easier to use.  While you are deciding on the “perfect” choice for your validated CMMS system, you may want to consider implementing GxPReady! Suite with its low cost and commitment to be in compliance during the selection process.  In many cases, GxPReady! Suite provides the best long-term balance for FDA and non-FDA regulated companies.

Basic Information (as applicable to your company)

GMP RequirementIs the software required to meet GxP and/or 21CFR11 requirements?
IT ResourcesDoes your company have internal resources to manage a validated system?
Validation ResourcesDoes your company have validation resources internally for change management?
HardwareDoes your company have validated IT hardware systems to support locally installed GMP software?
Programming ResourcesDoes your company have software engineers qualified to code software to your requirements?
TimelineWhat is the timeline required to meet for installation and qualification of your solution?
UsersHow many users will need access?
Equipment ItemsWhat is the approximate number of equipment items?
Current Data FormatWhat is the current format of any historical data you may have (logbook, spreadsheet, other system…)
Data ImportDo you need to import the data?
ResourcesIs your department resourced to use software or do you need data entry/admin support?
PurposeWhat is the main purpose of your need for software?
BreadthDoes the planned use for software affect your department only, or others also?
Budget (Initial)What is your budget for the initial up-front costs.
Budget (Maintenance)What is your budget for the ongoing maintenance costs.
IntegrationWhat level of software integration do you need?
EquipmentHow many pieces of equipment do you have to track (approximately)



Software Package:_______________________

(Complete one for each potential solution to compare)

CategoryCost ($)Time (Months)
Up-Front Costs/Time
Generating/Approving URS
Generating/Approving Specs
Installation Hardware/Software
Generating/Execution of Validation for Hardware/Software
Up-front software setup costs
System Configuration
Annual Subscription/Site
Additional Cost/User
Additional Charge per Equipment Item
Data Transfer From Current System
Software Updates
Time Required to Implement/Qualify



Ongoing Costs
Data Entry Time
Change Control Documentation
Technical Support
Minimum Contract Duration
Early Termination Costs
Updates/New Releases
Additional Costs/User Lic.
Additional Cost/Equipment Item
Additional Items
Free Trial


Overall Assessment of This Software Solution


DescriptionAssessment (0=worst fit, 10=best fit)

Does the solution meet your GMP requirements?

Are the functionality/features acceptable?
Can the solution be approved/implemented within your timeline?
Is the solution achievable with your resources?
Are the up-front costs of the solution acceptable?
Are the recurring costs of the solution acceptable?

Are the support services (e.g. trial results, data entry, data transfer, tech support, etc) acceptable?


Overall assessment of the solution for you (on a scale of 0-worst fit to 10-best fit):________