It is just a guess, but over the last 25 years, I have probably helped about 100 companies transition from paper-based systems to automated systems for managing documents, quality processes, and training activities. One thing I have learned is that for some companies, the transition is fast and relatively painless, and for others, it can be dreadfully slow and frustrating.
The reasons for the disparate experiences vary, but there are some consistent patterns related to how the companies prepared for the transition. Here is a set of recommendations to help ensure your transition to an automated Quality Management System is as painless as possible ( along with an estimate of the time each step should take).
1. Document Your Current Processes and Identify Gaps (8 hours)
You do not need to create complete manuals or process flows, but before jumping into an automated system, take the time to document your existing quality management processes. Specifically, create a table of your key processes, identifying key stakeholders, approvers, and timelines. Add to the list the actual forms or documents created by the process and where those artifacts are stored. It may seem tedious, but this step will greatly accelerate the process of configuring your new automated system.
With your list of processes complete, identify processes that are missing compared with what’s offered in the automated system. For these missing processes, complete the same information: who originates the process, participates in it, and has approval authority.
These steps aim to clarify what you have in place today and encourage you to start thinking about the processes you will be adding as early in the transition as possible.
2. Create a List of the BUSINESS Goals You Have for the Automation Initiatives (2 hours)
One common mistake when automating processes is to try to do too much at the outset. This can result in a very large scope and delays in obtaining the benefits.
To avoid this, make a list of five major results you want to achieve by moving to an automated system. For example, is it to improve compliance tracking, speed up document approvals, or get enhanced reporting capabilities?
Defining specific goals will help you prioritize the aspects of the system that will deliver those benefits. It will also guide your configuration efforts, ensuring the system aligns with your objectives right from the start.
3. Engage Your Team Early On (On-going, 1 hour a week)
When you implement a new, automated QMS, the people who manage the processes that are being moved to the new system can be your biggest asset or your biggest obstacle. Engage them early and often, starting with explaining the “why” behind the change and how it will benefit them. Without this step, they will almost certainly perceive the new system as a threat.
Ideally, a cross-functional project team should be established with representatives from Quality, IT, Regulatory, and other relevant departments. This team will play a critical role in providing input on requirements, testing the system, and driving adoption. Ensure that senior leaders and end users are included to get a balanced perspective when making key decisions.
4. Take the Time Now to Tidy up Your Records and Documentation (24 hours)
The step in an automation project most subject to delays is transferring data and documentation into the new system. Knowing where things are now and how they are organized, named, and categorized can greatly facilitate this process.
Take the time to clean up your existing quality documentation, training records, and other data that will be transferred to the new system. Eliminate duplicate documents, archive outdated records, and standardize folder names and file naming conventions. When data is well-organized before migration, it dramatically speeds up the implementation process.
5. Define an Initial Phase with a Limited Scope (2 hours)
I have saved the most important for last. The single biggest cause of challenging transitions relates to the scope of the initial implementation. When the transition to an automated system includes ALL processes and ALL artifacts, the project will invariably collapse under its own weight. And that will delay ANY benefits until every aspect of the system is operational.
Instead, define an initial phase with a limited scope. Choose the processes for that phase based on two attributes: The degree to which they are well-defined and the degree to which they will deliver measurable benefits. This approach will ensure that the overall initiative is built on a solid foundation of confidence and results.
Careful Planning Drives Success
Automating a Quality Management System can be a game-changer for growing pharmaceutical and medical device companies, improving efficiency, ensuring compliance, and saving money. But a successful transition doesn’t happen by accident—it requires careful planning and a thoughtful approach.
By documenting current processes, setting clear business goals, involving the right team members, organizing data, and starting with a manageable project scope, you’ll set the stage for a smoother implementation.
These five steps will reduce the risks associated with moving to an automated QMS, accelerate the benefits, build confidence, and set the stage for additional investments.