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)
| Category | Description | Data |
| GMP Requirement | Is the software required to meet GxP and/or 21CFR11 requirements? | |
| IT Resources | Does your company have internal resources to manage a validated system? | |
| Validation Resources | Does your company have validation resources internally for change management? | |
| Hardware | Does your company have validated IT hardware systems to support locally installed GMP software? | |
| Programming Resources | Does your company have software engineers qualified to code software to your requirements? | |
| Timeline | What is the timeline required to meet for installation and qualification of your solution? | |
| Users | How many users will need access? | |
| Equipment Items | What is the approximate number of equipment items? | |
| Current Data Format | What is the current format of any historical data you may have (logbook, spreadsheet, other system…) | |
| Data Import | Do you need to import the data? | |
| Resources | Is your department resourced to use software or do you need data entry/admin support? | |
| Purpose | What is the main purpose of your need for software? | |
| Breadth | Does 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. | |
| Integration | What level of software integration do you need? | |
| Equipment | How many pieces of equipment do you have to track (approximately) |
Software Package:_______________________
(Complete one for each potential solution to compare)
| Category | Cost ($) | Time (Months) |
| Up-Front Costs/Time | ||
| Generating/Approving URS | ||
| Coding/Testing | ||
| 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 | ||
| Training | ||
| Data Transfer From Current System | ||
| Software Updates | ||
| Time Required to Implement/Qualify | ||
Other:_______________ | ||
Other:_______________ | ||
| TOTAL UP FRONT COSTS | ||
| Ongoing Costs | ||
| Data Entry Time | ||
| Change Control Documentation | ||
| Backups/Maintenance | ||
| Technical Support | ||
| Minimum Contract Duration | ||
| Early Termination Costs | ||
| Updates/New Releases | ||
| Additional Costs/User Lic. | ||
| Additional Cost/Equipment Item | ||
| Other: | ||
| Other: | ||
| TOTAL ONGOING COSTS | ||
| Additional Items | ||
| Free Trial | ||
| Other:_______________ | ||
| Other:_______________ | ||
Overall Assessment of This Software Solution
| Description | Assessment (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):________
