An Electronic Quality Management System (eQMS) is a Software-as-a-Service (SaaS) tool used to fulfill all the requirements of a paper-based quality management system with automated processes to increase productivity and oversight.
Which eQMS is right for your organization? The purpose of this article is to help you determine what your new eQMS must do to fulfill the needs of your organization and to offer some advice on how to ensure that your organization is adopting the right eQMS. We will also touch on different rollout strategies. This article will focus on life sciences eQMS, but many ideas are usable across several disciplines and business verticals.
Keep in mind that implementing an eQMS is like developing a complex, technical project. The strategies and tactics are interconnected. Thinking through the entire project and as many use-cases as possible will help inform both the appropriate strategies and the best tactics for your organization. This means gathering a variety of input from people across all functions within your organization. A cross-functional team that includes engineering, IT, quality, accounting, marketing, manufacturing, and supply management will have a greater chance of success than just the quality team determining which eQMS to use.
| Note on strategies and tactics In a perfect world, the strategies are determined first and then the tactics are defined to support and fulfill the strategies. The strategy informs the tactics. The tactics do not inform the strategy. With complex software systems—which includes eQMS packages—strategies and tactics become more interconnected, and the existence of certain tactics may change strategies. |
Planning the entire process before starting helps determine how strategies and tactics relate to each other. The process may look like this.
Gather User Needs
User needs are high-level requirements. Developing a detailed list of your organization’s eQMS needs can help you research potential eQMS packages. When you know the high-priority user needs, you can better determine which eQMS best fits your organization. The following paragraphs will ask questions to help you develop the user needs for your eQMS. These questions are designed to be a launch pad for you as you develop your own questions to determine your organization’s needs.
1. What is your organization’s business? Medical device manufacturer? Pharmaceutical manufacturer? Biotech? Contract manufacturer? A combination of two or more? Some eQMS packages are only designed for a specific type of life science quality system.
2. What are your organization’s priorities with the new eQMS? Do you want to increase productivity? Simplify or harmonize QMS processes across disparate business sites? Do you want to make it easier for the quality department to manage the quality system? Are any of these high-level priorities more important than others?
3. Who is going to use your eQMS? Define each specific user type. This may include quality management, document control, engineers, scientists, marketing, accounting, human resources, manufacturing, supplier control, shipping and receiving, etc.
4. Does your organization already have an eQMS? What workflows are they currently using? Are the workflows efficient? Can and should they be updated to increase productivity?
To determine efficacy and efficiency of current systems, you can talk with the current users or a subset of the current users. Creating a simple, short questionnaire may be a good way to get feedback on the organization’s current system: what the users like, dislike, and which features they wish the system had. Be sure to ask questions of representatives from each type of user determined from question 3, otherwise you may roll out a system that is great for your quality department but is unusable for another department.
5. Review recent CAPAs related to the current quality system or current eQMS. Are there any systemic issues that could be addressed by a new eQMS? Are the systemic issues caused by poor processes? Overlaying an eQMS on poor processes adds an expensive addition that may mask underlying issues.
The information gathered from questions 1 through 5 can be synthesized to create high-level workflows for each type of user.
6. What workflows or actions would each type of user require to perform tasks within the eQMS? For users that have similar workflows, like retrieving controlled documents, can their workflows be the same or do they need to be different?
Developing user needs and workflows can help you and your organization figure out all the needs your eQMS should fulfill. It’s important to organize by priority. No eQMS is going to fulfill your user needs without major customizations that will adversely affect your timeline and budget.
Research eQMS Software Providers
When researching eQMS packages, be sure to find one that can fulfill your high-priority user needs and workflows. The less you need the eQMS customized, the less expensive it will be, and the faster you will be able to roll out the new eQMS.
| Note on research While researching different eQMS software packages, you may determine that a featureset in a certain eQMS changes your user needs. Or, there could be a feature or workflow you had not considered that the eQMS you are currently reviewing fulfills. Be sure to update your user needs. |
There are lots of eQMS providers. Determining the number of providers to interview, receiving in-depth demonstrations, and asking for quotes is contingent on the size of your organization, your current supplier processes, and on how much time your team has to vet potential eQMS providers. Vet as many as you can. The following areas may help you formulate additional questions to ask potential eQMS providers.
Software Integrity
What happens when things do not go as planned? How does the eQMS provider respond to adverse conditions? You can present the eQMS provider with the following potential scenarios to see how their company behaves.
1. The eQMS provider finds, or is notified of a defect in their software that could potentially erase clients’ data. Do they have a documented process on how to handle catastrophic defects? How does the eQMS provider assess the defect? How does the eQMS provider communicate the defect to their clients?
2. The eQMS provider has discovered a data breach. Some of their clients’ data has been accessed by hackers. What does the eQMS provider do?
3. The eQMS provider has been notified that a third-party tool or hardware they use has a potential security exploit. How have they handled these notices in the past?
4. The eQMS provider finds, or is notified of a non-catastrophic defect that does not have a workaround. The defect causes some functionality not to work and there is no way for the client to perform the task the defect is blocking. What process do they follow when assessing the defect and communicating with clients?
5. The eQMS provider finds, or is notified of a non-catastrophic defect that has a workaround. The defect causes some functionality not to work but the task the client wants to perform can be accomplished by performing some other actions on the software. What process does the eQMS provider follow when assessing the defect and communicating with clients?
6. The eQMS provider receives updated Standards or Industry Guidance that the eQMS software does not fulfill. How does the eQMS provider ensure that the software remains compliant?
Services
Aside from the eQMS software, the eQMS provider may have other, related services for their clients.
1. If your organization would like a new software feature in the eQMS, how do they notify the eQMS provider? How likely is it for the eQMS provider to create new features based on client feedback?
2. Does the eQMS provider have up to date training materials? Do the screenshots or functionality videos in the training materials match the current user interface and user experience of the eQMS software?
3. Does the eQMS provider have a detailed rollout plan or best practices that your organization can review and modify to meet its needs
4. Does the eQMS provider have offsite data backup services? If not, do they provide automated access to their backend software for third-party data backup services?
Long Term Behaviors
Another thing you want to determine before purchasing an eQMS is how the eQMS provider will behave over the long term. Are you able to talk with some of their existing clients? Does the eQMS provider have reviews on the Internet? Can you talk with an organization that used to be a client of the eQMS provider but has since moved on to another eQMS provider?
It is a good idea to see how well your organization fits into the eQMS provider’s client-base. Is your organization similar in size and scope as the majority of the eQMS provider’s clients? If your organization is substantially different from the clients the eQMS provider is used to working with, it may cause some communication and expectation issues.
eQMS Rollout
Once you have determined and purchased your eQMS, it’s time to have your organization use it. Your eQMS provider should have some best practices and resources available to help make the rollout go smoothly. During the rollout of the new eQMS, your organization still needs to get work done and still needs to be compliant to its own processes and procedures. Your rollout plan needs to harmonize your existing quality system with the new eQMS; adopt new processes in a tiered, systematic method; provide access to the new eQMS to business units; and ensure that the correct technology infrastructure exists to support the new eQMS.
Harmonization
Your new eQMS may require changes to your existing quality system. Depending on how you have your current quality system setup, your quality manual, processes, and procedures may only require minimal updates. Your work instructions will need to be updated to describe the workflows for the new eQMS system.
There are several ways to harmonize your existing quality system with the new eQMS. One approach is to update your current quality system documents to refer to both your old system and the new eQMS before beginning the eQMS rollout. As business functions and company sites fully adopt the new eQMS and no longer use the previous quality system’s processes and work instructions, you can update your quality system again to remove references to the obsolete quality system.
Adoption
Your rollout plan should include timelines and milestones for how and when each business function and company site adopts the new eQMS. When creating your tiered adoption plan, start with smaller business functions and sites before having larger business functions adopt the new eQMS. For instance, if your organization is mostly focused on manufacturing with a little bit of engineering it would be wise to have your smaller engineering team adopt the new eQMS first. That way if there were any unforeseen issues, it is easier to respond when dealing with a smaller team and smaller business function.
One aspect of adoption that tends to get overlooked is how to deal with business units that do not want to change from their current quality system. One tactic to employ includes describing the benefits to the organization as a whole, and to the business unit (increased productivity, easier metrics, etc). Another tactic includes allowing the business units a voice in the eQMS determination process. The questionnaires mentioned above in the Gather User Needs section may help business units feel that their opinions and concerns have been heard and addressed.
Disposition
Your rollout plan should also take into account how the separate business units will access and interact with the new eQMS. Will every business unit use their computers and laptops? Will individuals on the manufacturing floor access the eQMS via a tablet or smartphone? Is the new eQMS able to display their web portals in every resolution and orientation required to meet each business unit’s needs?
Infrastructure
The plans should address any infrastructure requirements. If all your business units are in the same physical location then the needs are straightforward. You will need a reliable and fast internet connection. If your business units are distributed all over the world at several company sites, you need to ensure that each site rolling out the new eQMS has access to the eQMS provider’s web portal. You will also need to make decisions about localization issues of the eQMS web portal: languages, formatting, etc.
Continuous Improvement
Your new eQMS will be evaluated regularly during your organization’s management reviews. Keep in mind that your eQMS provider will continually make software updates to fix defects, add features, and stay on top of any cybersecurity issues. As with any supplier, you will need your eQMS provider to inform you about any major software updates—before they occur—that could affect how your business units interact with the eQMS.
Conclusions
There are several things to keep in mind and plan for when moving your organization to a new eQMS. The complexity of the process greatly depends on the complexity of your organization. The larger the organization, the more difficult the new eQMS will be to define, choose, and roll out. If you are developing a plan to roll out an eQMS for a large, distributed organization, spend as much time as you are allowed to gathering user needs, vetting eQMS providers, and making a detailed plan on how the rollout should happen. Good luck.
If you want someone to help out with developing and implementing a plan for your organization, please feel free to contact me. tech@luova-solutions.com Or send me a message through Contact Us Now – Luova Solutions (luova-solutions.com)
