You did your research, received budget approval, and picked out the right electronic quality management system (eQMS). Those are huge steps towards improving the bottom-line success of your company as it relates to quality.
Now the real work begins. Because a quality management tool is a serious investment, the implementation you begin today will have major repercussions for years to come. Poor implementations lead to lots of wasted time and money, and can slow your time to market, so it’s best to have a plan in place and know what you’re getting into before diving in with both feet.
Above all, communication between Quality, the QMS software vendor, and the rest of your company is the biggest determining factor when it comes to predicting implementation success. Keep that in mind when you’re staying organized around:
- Preparation
- Software Implementation Timeline
- Configuration
- Support
- Adoption
Preparation
Before beginning your implementation, you’ll want to document the goals of the quality management software and the company as a whole. Not only is this required by FDA inspectors, being clear on your goals will help define what success means, especially when demonstrating the ROI of the QMS tool to your C-suite later on.
Next, you’ll want to have your quality team in place, and involve the IT department if necessary. Knowing who you can rely on will keep things running smoothly during the process.
Finally, you’ll want to communicate this software change to the rest of the company and determine how they’ll access the system once it goes live. You may have to buy additional equipment for workers at remote sites, labs, etc. in order for them to log in and stay compliant.
Timeline
Now that it’s time to begin the actual implementation, you’ll have to set a realistic target date to go live in the system. Consider your team’s own deadlines and commitments, because more likely than not, this work will be done on top of daily responsibilities. If you’re hiring an experienced quality management consultant to help, it will add to the cost, but it will also speed up the process.
(Not sure what a "normal" QMS software implementation timeline looks like? Check out our guide.)
There are a few things to think about when estimating a timeline that covers the scope of an implementation:
- Type and quantity of documents migrating into the new QMS system
- Availability of previous training histories or training records
- Assigning correct permissions to staff based on their expected usage and role
- Complexity of your training matrix (how will training be assigned/who’s responsible to train on what?)
- Complexity of existing processes and how seamlessly they transfer into the new system
Additionally, it’s important to know if there are fees/penalties associated with delaying or deviating from the agreed-upon proposal. For example, adding documents after the initial migration plan may come at a cost, so it’s best to know that information up front.
Implementation is a delicate balance. You’ll want to give yourself time to migrate the documents you want (and archive the ones you don’t), and build out processes in a thoughtful, organized manner, but you’ll also want to get the most bang for your buck and start using your new system as quickly as possible. Your vendor’s project manager can help you set a timeline that works.
Configuration
Often, the vendor will provide a sandbox environment that allows you to test-drive the system. This is critical because some eQMS solutions are more flexible than others. You’ll find out how much of your process (if any) needs to be reconfigured to adapt to their system.
Ideally, you’ll be able to transfer your existing workflows into the new eQMS without a problem, as consistency will lead to better adoption from your co-workers. However, if building a custom configuration to match an existing process requires extra work from the vendor’s IT team, it may affect your budget and timeline.
Support
Once you’ve kicked off the implementation process, the vendor’s project manager and support team will be in contact to make sure you’re trained on the system, staying on schedule, and managing resources properly.
Still, you never want to feel like you’re on your own. That’s why it’s important to know how much help is available, where to find it, and how much it will cost. You’ll also want to know what you can expect in terms of response time from the support team. As long as both sides are clear about what’s included and what’s extra, you’ll be in good shape.
Adoption
Even the best eQMS software is worthless if no one uses it. That’s why the best implementations have a roll-out plan to ensure successful adoption. This plan can include:
- A company-wide email stating the reasons for moving to an electronic system, the short- and long-term benefits, and why employees should be excited about how the system will make their workday easier.
- Executive-level support that reiterates the importance of maintaining compliance to align with company goals.
- An invitation to attend a general user training led by the Quality team, the consultant, or a training specialist on the vendor’s side.
- Supplemental materials like FAQs, articles, videos, and a link to the eQMS’ knowledge base. These will help general users find answers quickly on their own.
- Internal support from the quality team - another line of defense for users to get help before resorting to submitting a ticket.
- Clear instructions on how to submit a ticket for the vendor’s customer support team.
Along with a roll-out plan, it’s recommended that you add a course or curriculum within the eQMS on proper usage. These instructions can be tailored and assigned to specific groups, depending on their role (General User, Document Manager, System Administrator, etc.)
Providing your co-workers with lots of information before the system goes live will keep questions and complaints to a minimum and increase buy-in for a successful transition.
For more information about what a successful implementation can mean for cGMP, cGCP, and other GxP-regulated organizations, read how ZenQMS improved SQ Innovation’s process automation, configurable workflows, and audit-readiness.