Selecting a Computerized Maintenance Management System (CMMS) for use in the Bio-Pharma industry is somewhat different than for other industries in that the consideration for regulatory compliance must be kept in mind. The requirements for maintenance in 21CFR 211.67 are unhelpfully vague as they only say that Equipment shall be maintained as appropriate, written procedures shall be established, and responsibilities shall be assigned. The maintenance part of this section of the regulations is combined with the Equipment Cleaning part and almost seems like an afterthought.
But don’t be fooled by the paucity of regulatory language regarding maintenance. FDA inspectors often look at the preventive maintenance and calibration programs for facilities and equipment as well as how those programs are developed, maintained, and reported on.
The tool most bio-pharma companies use is a CMMS system. These software programs run the gamut from simple non-configurable, non-customizable databases to highly complex, almost completely configurable/customizable systems. So, if you have been tasked with selecting an implementing a CMMS, how do you go about it?
In my career as a bio-pharma employee and as a consultant, I have had some level of responsibility for CMMS implementation numerous times. For some projects, I have been completely responsible for selection, installation, data input, and qualification for systems and for other projects, I have acted as a stakeholder and given my input to the project from that perspective. I have experience with simple databases with little configuration, to more complex systems that were highly configurable. Here are some things that I have learned that can hopefully help you out if you are embarking on a similar project.
The first step is understanding the user requirements. Writing a User Requirements Specification (URS) will help you understand what kind of system you are looking for and which systems can fulfill those requirements. When writing the URS, you need to include requirements from ALL stakeholders, not just the maintenance department. Other than the normal tasks maintenance requires from a CMMS, you should ask questions such as:
Does the IT department require Server based systems, or do they allow SaaS (Software as a Service) which is cloud-based?
What level of qualification will be required?
Is 21CFR Part 11 (electronic signatures) compliance required?
How many users will there be? How many requestors? (this can impact the cost of a system).
What is the budget the company is willing to spend?
Are in-house resources available to do data input, system configuration, and qualification or will those things need to be contracted out?
How many user levels will be needed?
Do you want the system to be accessible on mobile devices? How will this be qualified?
What kind of information will the Quality department, Management, and other key stakeholders need to get out of the system (this impacts the reporting module)
Do you want reports to be customizable within the software, or is someone trained on Crystal Reports or some other reporting tool that is compatible with the CMMS?
After the user requirements are defined and agreed to by all the stakeholders, the research can begin. You will find that there are dozens of CMMS systems on the market. Some are designed for use in specific industries, and others say they can be used by any industry. To narrow down the search, look at industry specific requirements (e.g., Part 11 compliance) to reduce the potential number of candidates.
In the Bio-pharma industry, your CMMS will almost always need to be qualified at some level. This requirement can be another gate keeper. Most CMMS systems do not even mention qualification or validation on their website. If so, steer clear of those packages. Others are a little savvier and will mention it, but when you question the sales rep, he/she may not be able to answer your questions or even know what validation means. Again, this should be a red flag. Lastly, you will find CMMS systems that are commonly used in bio-pharma, these are the ones that you should put on your short list.
After you have settled on a few contenders, the next step is to talk to the sales reps to get a better feel for other bio-pharma clients they have where the system is installed and qualified. Ask for references and talk to those references about not only their experience after the software was qualified, but also about the process to get it installed, configured, data input, and the qualification process itself. Find out how helpful the vendor was AFTER they had a Purchase Order in hand.
Demonstrations are the norm for software packages of all types and CMMS systems are no different. Line up a demo with your top 3-4 vendors and be sure to invite all the stakeholders to this meeting including but not limited to IT, Validation, Maintenance, Engineering, and Management. Make sure that during the demo, you have the URS in front of you so you can be confident that the package can meet all the requirements.
After your demo, you will need to get pricing. To do that efficiently, you should send the approved URS to the vendors and ask them to ensure (as a part of the quoting process) that their software meets each requirement. I recommend that you develop the bid tabulation spreadsheet ahead of time and ask each vendor to answer if each user requirement is met with their standard package, or the cost for additional modules/features that enables their software to meet that requirement. This will make the job of comparing the bids easier when you get them back.
Assemble the bid tab and include pricing, reference checks and any comments you have and then send it out to the stakeholders to help everyone arrive at a final decision.
Once you have selected a system, the work has just begun! Stay tuned to this blog for a future column on implementation.
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