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Training is all about complying with industry regulations - true.
More importantly, though, training programs are intended to ensure the competency of your team, leading to higher-quality devices.
But the ugly truth is, so many medical device companies are struggling to maintain their training programs right now. We’ve all been forced to manage training digitally. And no one feels this pain more than a training manager who is trying to ensure up-to-date training practices in a remote, digital world.
Now there are probably a few things wrong with current ways of implementing a training program that has led to these pains - and it all starts with the systems you have in place. From printing and pushing paper records and tracking down signatures to maintaining multiple logins, dashboards, and training matrices, it gets increasingly manual and difficult to keep track of who has completed training - on what - and when.
Easy access to training records has become increasingly important for medical device companies. Having accurate training records on hand is essential to staying audit-ready, and 60% of participants from our 2020 State of Medical Device survey said that staying audit-ready was a high priority for the coming year. An auditor is destined to ask, “Can I see who all have been trained on this procedure?” Having the ability to track and provide objective evidence of your training program records is only made harder with disconnected, manual systems, and processes.
There is one role in your organization that bears the burden of this problem the most - the ones who push the paper and check off the box for compliance activities. It’s your quality managers.
They’re on the hook to organize training records, update training matrices, and (you guessed it) ensure that a viable audit trail exists. Quality leaders can attest that it is getting harder and harder to manage training activities and close the loop between processes with disconnected systems. The majority of their time is being spent on pushing paper and tracking down signatures, rather than carrying out strategic, value-adding activities. As a result, quality leaders are putting your organization’s compliance at risk.
But this isn’t just a problem for your quality managers. It is for every training manager who is out there working hard to ensure the right people are trained on the right items at the right time.
The problem is that they just don’t know where to start with the systems in place.
Managers are stuck between copying, pasting, and merging records from disconnected places, updating training matrices, and nagging people to sign-off on training activities.
So to make life easier, they've turned to digital solutions to help manage training, route for signatures, and make records more accessible. There are a lot of tools out there that are focused on solving a single problem, and many more that help complete tasks.
Don’t get me wrong, these tools are used with the best intentions for getting the job done. But the reality is that many training and quality managers find that they're just not scalable. And none of these tools can be integrated into your quality system to help your team stay up to date on training, while also ensuring your quality managers have access to the records they need - when they need them.
So what if you could give your quality and training managers a streamlined training solution that gives them time back in the day and keeps your organization in compliance?
With Greenlight Guru’s Training Management, now you can.
Greenlight Guru’s Training Management simplifies regulatory compliance and streamlines the training process so you can ensure compliance and competency within your organization.
Quality managers and training managers can track and provide objective evidence that your employees have been effectively trained on processes, procedures, changes, and other QMS documentation - all in a single, integrated system.
Here’s how Greenlight Guru’s Training Management will help you make the training process easier…
Don’t make it more complicated for the person responsible for conducting or completing the training. With Training Management fully-integrated into your QMS, you reap the benefits of having a centralized system in place that serves an important purpose in your overall, closed-loop quality ecosystem.
Have complete, accurate, and up-to-date access and visibility to all training activities directly tied into your QMS. This makes day-to-day operations run smoother and keeps a medical device company even more prepared for audits and inspections.
Centralized system for training on documents, including new processes, as well as revised procedures and forms, within your QMS
Automated training tasks and notifications to streamline tracking of training events
Increased visibility into training progress and reports
Require trainer sign-off to ensure training activities are effective
Avoid putting your company’s compliance at risk and get time back in your day by saying goodbye to manual, labor-intensive tools. Be able to track and provide evidence that your employees have been effectively trained on processes, procedures, changes, and other QMS documentation.
Complete, accurate, and up-to-date access to all training activities
Simplified tracking of training status with progress metrics on document level and by individual(s)
Reduction in manual work with automated reminders - no more nagging, tracking, and searching for training reports
Gain visibility and understanding of training impacts from changes to procedures, instructions, and policies
No more scrambling to find records and gather signatures, or trying to cover your tracks while your auditor continues to pull at threads in your quality system. Arm your training managers with objective evidence and traceability for demonstrating effective training and compliance.
Stay prepared for audits and inspections with easily accessible and comprehensive training logs and records.
Closed-loop traceability of training activities within a single, integrated system
Part 11 compliant sign-off, audit trails, and password requirements
Connect people, training, and records to make demonstrating compliance easier
With Greenlight Guru Training Management, all of your training activities are centralized and integrated into your medical device quality system. Now you can always be sure that you’re training the right people, on the right things, at the right time.
Want to remove the burden of manual, disconnected training processes and begin streamlining your training program?
Nick Tippmann is the Chief Marketing Officer for Greenlight Guru, a MedTech Lifecycle Excellence Platform (MLE) that provides an industry-specific solution to help medical technology innovators around the world use quality as an accelerator to move beyond baseline compliance and achieve True Quality. Tippmann is...