Are your training materials in a state of control? If your stomach drops when the inspector asks to see your training records, the answer is probably "no."
The problem isn't that the training hasn't been done, it's about proving it. And with out-of-control training records, finding that proof is going to take a lot of your time.
A training matrix isn't just another quality system tool - it's your insurance policy against these moments of panic. It transforms scattered training documentation into a clear, actionable snapshot of your team's capabilities and training gaps -- critical for any GxP regulated organization.
What is a training matrix?
For life sciences organizations regulated by the Food and Drug Administration (FDA), tracking employee training takes priority. That means making sure training is properly assigned, completed, recorded, and verified for everyone. To stay organized and compliant, these organizations rely on a training matrix for their employees.
In its simplest form, a training matrix is an organizational tool that companies use to determine what their employees are responsible to train on -- according to the requirements of their job function -- for compliance purposes. These assignments can include standard operating procedures (SOPs), engaging with video and audio recordings, and participating in live training sessions.
Brushing up on Quality + eQMS essentials?
Download the free eQMS 101 eBook for a refresher on the foundations of Quality Management, including:
— What is an eQMS?
— How do you build a Quality Management System?
— How much does an eQMS cost?
— How do you prove the ROI of an eQMS to leadership?
Why do you need a training matrix?
As far as the FDA is concerned, it is the responsibility of organizations in regulated industries to make sure all necessary job tasks are performed in a consistent manner and training documentation remains in a state of control.
Failure to have, or properly utilize, relevant SOPs may result in a warning letter or Form 483. These notices can be financially damaging and disastrous to a company’s reputation as they are made public on the FDA’s website and shared by the life sciences community at large.
When procedure violations or incomplete training compliance leads to sanctions by the FDA, "inadequate training of personnel" is often cited as the cause. Lack of training on required SOPs is the reason behind many costly failures during inspections.
The Code of Federal Regulations Title 21 states:
Each person engaged in the manufacture, processing, packing, or holding of a drug product shall have education, training, experience, or any combination thereof to enable that person to performed the assigned function
Training in current good manufacturing practice (CGMP) shall be conducted by qualified individuals on a continuing basis and with sufficient frequency to assure that employees remain familiar with CGMP requirements applicable to them.
Why spreadsheets can't handle a complicated training matrix
A training matrix can help avoid these problems, yes, but a company that relies on a training matrix inside a paper/spreadsheet-based learning management system (LMS) or quality management system (QMS) is at a disadvantage. In fact, FDA compliance issues is one of the top signs your training matrix just isn't working.
When new sites and employees are added, the amount of SOPs increases exponentially. And when SOPs increase, so does the complexity of the matrix, causing problems down the road. An Excel spreadsheet simply can’t handle a training matrix of that complexity, nor can it provide real-time updates.
The benefits of an electronic learning management system (eLMS)
The FDA sets a very high bar for compliance. There can be thousands of regularly-issued SOP changes that affect thousands of employees. Not only does each employee have to train on each required SOP, but proof of that completed training has to be documented.
The sheer volume of SOPs that have to be checked and validated for each employee practically requires an electronic learning management system (eLMS) be used to maintain compliance.
What is an electronic learning management system?
An eLMS is a software application that helps deliver, track, and report on the completion of training materials in order for employees, and the parent company, to meet compliance standards.
An eLMS can either be it's own standalone platform, or can be incorporated into an all-inclusive eQMS through a training module.
Many life sciences companies still work with outdated paper-based training matrices or hybrid systems that cost thousands in annual administrative work hours.
Alternatively, a fully-implemented eLMS solution can streamline and automate training in a way that eliminates common errors and provides regular updates to improve compliance.
Plus, an eLMS can administer and grade proficiency tests and control the sequence of courses. When one course is satisfactorily completed, the next course in the sequence is automatically launched or scheduled, and progress is immediately recorded in the training matrix. Managers no longer have to chase employees to remind them about training or beg for signatures. As a result, administrative work is drastically reduced.
eLMS vs eDMS vs eQMS
To streamline a company’s quality control operations, including managing the training matrix, many regulated companies opt for an all-in-one electronic quality management system (eQMS), which serves as the eLMS, eDMS (electronic document management system) and so much more.
The benefits of an eQMS
An eQMS is a single, integrated quality management software that helps teams effectively manage, track, and report on their quality processes. This quality management tool makes it easier to stay compliant, compared to an expensive collection of disparate software products that may not communicate well with each other.
eQMS software handles the full range of quality control data processes to ensure compliance. Along with training management, an eQMS supports:
- Document Management
- Issues and Change Control Management, including deviations and CAPAs
- Auditing and Vendor Management
- Quality management data reporting
Why life sciences companies should consider a fully validated eQMS
For life sciences companies, a fully validated eQMS offers 21 CFR Part 11/ Annex 11-compliant e-signatures, ISO 9001 and ISO 27001 certifications for meeting the regulatory requirements of a quality system, and a SOC 2 Type II report ensuring complete data privacy and security.
An eQMS is infinitely scalable to handle the quality demands of companies of any size, across any life sciences vertical, from multi-site CROs to innovating biopharmas. And cloud-based systems connect remote teams and sites with no loss of accuracy or security.
How do you create a training matrix?
Every organization's training matrix will look different, but there are a few key steps needed to get started. First, identify the skills, competencies, and regulatory requirements required and relevant for each job role within the organization.
Next, list the training courses, SOPs, and other assignments available and align them with the identified skills and requirements using a structured format. Technically, you can do this in a spreadsheet, but the more employees and documents you have, the quicker this will grow out of control. The simplest, most effective method is to you an eQMS with a robust training module.
Your matrix should include details such as employee names, required courses, completion statuses, and deadlines, allowing for easy tracking of progress and compliance. Finally, regularly update the matrix to reflect any changes in training needs or regulations, ensuring that it remains a relevant and effective tool for workforce development.
Curious how an eQMS can automate training management and streamline your training matrix? We can show you!
