How to stay compliant with FDA training requirements

In this article, we will dive deeper into the FDA training requirements we see organizations try to comply with in various industries – and how AG5’s skills management software is helping them do so.

How to stay FDA compliant

Because of quality, health, and safety standards, the FDA is an important regulatory body for businesses in the pharmaceutical, food, beverages, medical – and even logistics–  industries.

These organizations must ensure their products and procedures comply with FDA regulations. This can be a challenge for manufacturing or logistics organizations that use distinctive software for their production or operational processes, but still use Excel for part of their training processes.

In this article, we will dive deeper into the FDA training requirements we see organizations try to comply with in various industries – and how AG5’s skills management software is helping them do so.

Why Excel presents challenges for FDA compliance Copied

Most organizations have a common goal: ensuring their employees are qualified to do their jobs.

However, we have noticed that the most common tool for managing employee training is a good old Excel spreadsheet. This makes sense, especially for managers who need an overview and insight into their team’s skills gaps: a simple Excel matrix enables them to identify these gaps and understand who still needs what training to ensure their teams are fully qualified

This setup also works for organizations that must comply with FDA regulations, although it becomes challenging for larger or global organizations. Such organizations often have multiple sites across different countries, each of which is subject to training-related FDA regulatory requirements.

In this case, Excel spreadsheets are difficult to maintain. So how can an organization ensure all of its teams similarly manage Excel training data – and thus maintain high degrees of data quality, should an FDA auditor want to see how employee training requirements are managed?

This is precisely the challenge AG5 skills management software solves. In the next section, we’ll dissect a few training-related FDA regulatory requirements. We’ll also show how AG5’s capabilities and solutions can help ensure that you meet them.

A quick look at common FDA training requirements Copied

When it comes to FDA regulations, we recognize the importance of a training process that qualifies employees to ensure the safety and quality necessary to maintain public health.

  • For example, for Good Manufacturing Practices (GMP) for Drugs and Pharmaceuticals, under Title 21 CFR Part 211, Section 211.25 (Personnel Qualifications) [1], the FDA states the need for an employee to have education, training, and/or experience to perform their job
  • Similarly, for Quality System Regulations for Medical Devices under Title 21 CFR Part 820, Section 820.25 (Personnel) [2], the FDA highlights the importance of training employees, and the procedures for identifying and documenting employee training
  • For Food Safety, under Title 21 CFR Part 117, Section 117.4 (Qualifications of individuals who manufacture, process, pack, or hold food) [3], the FDA requires employees to possess the necessary education, training, and experience to perform their job – specifically necessitating that an establishment’s management must ensure all employees involved with its operational processes are qualified.

Meanwhile, organizations in the animal food industry must meet specific FDA regulations for employees who manufacture, process, pack, or hold animal food.

  • Here, requirements for responsibility, training, and record-keeping are clearly stated in Title 21 CFR Part 507, section 507.4: Qualifications of individuals who manufacture, process, pack, or hold animal food [4]

The FDA also has regulations for the transportation of human and animal food.

  • Title 21 1.910 [5] clearly states that the personnel involved in transportation need proper training. Additionally, section 1.912 states that these training records must be place and saved for a minimum of 12 months

Additionally, the FDA highlights the importance of electronic records and signatures.

  • Part 11 Electronic Records; Electronic Signatures [6] states that, for each product developed, the organization must ensure that the employee involved in the manufacturing process has the necessary knowledge and experience. This involves the training itself, and the practice of keeping electronic records – as well as electronic signatures of those involved – of the entire training process. This is because such trainings are typically continuous, rather than one-time, processes.

To keep such records, an organization must develop and implement a system that ensures high-quality training data, which is electronically recorded with electronic signatures. This system must also track and document the entire training process, encompassing data creation, modification, and deletion.

Meeting FDA requirements with AG5 Copied

When an organization wants to meet FDA requirements, it must have a process in place that ensures long-term compliance with regulation standards.

This means that all data that proves compliance is always ready and continuously assessed – and that managers or team leads don’t need to put in overtime to ensure it is complete, accurate, and up to date. You must also have a plan in place if employees are not meeting the FDA’s stated training requirements.

This is precisely how AG5 supports organizations in complying with FDA training requirements.

AG5 allows your organization to:

  • Ensure training compliance for the entire organization
  • Ensure global and local training compliance
  • Ensure an audit-proof way of working
  • Ensure integration with existing learning and HRIS systems

AG5 and global and local training compliance

Our global skills management solution allows organizations to maintain global training standards alongside local ones. It enables you to define global training requirements, roles, and training and share them with different parts of your organization.

Additionally, if other parts of the organization are subject to different requirements because of local regulations or standards, AG5 allows them to manage them, as well.

global and local training requirement

Ensure training compliance for the entire organization

Large organizations can consist of different departments that are subject to the same FDA regulatory requirements, but have unique training processes.

  • Some organizations may use a combination of skills and competencies
  • Others use training or competencies
  • Others still use qualifications and licenses

Additionally, we see organizations often using different structures to define training requirements:

  • Some have role-based requirements
  • Some have role-based, machine-based, and location-based requirements across various parts of the organization

We see organizations that are subject to FDA requirements typically have several things in common. For example, they often have decentralized and unique training processes, with each department using a separate Excel or Oracle database to manage their employees’ training requirements, role structures, and different skills, such as competencies, training, skills, curricula, licenses, and qualifications.

AG5 replaces Excel, Oracle, or other department-specific tools with a centralized tool for the entire organization. Our roles, qualifications, and requirements capability provides the flexibility for each department to maintain its unique structures and processes, while the organization can simultaneously maintain its global standards.

Ensure an audit-proof way of working

AG5 is audit-proof. Every activity performed within the platform is recorded, including all data creation, modification, or change.

There is a general overview of all actions, as well as a history log of all activities per feature. This includes the details of all data changes.

AG5 also provides you with master data management, ensuring high-quality training data. Our master data management capability supports your organization’s data integrity goals, as it allows you to define data owners within the platform. These data owners become part of an approval process whenever master data is changed. Additionally, AG5 offers a four-eyes principle feature to ensure data changes are always processed by at least two people

Additionally, AG5’s master data management capability also requires an electronic signature for every approval. Whenever a user wants to approve a data change, they must re-authenticate themselves for the electronic signature and the data to be recorded.

AG5’s master data management also provides audit trail reports in PDF format for all approved data changes. This provides your organization with the correct report during an audit to provide complete, accurate, and timely information– including an electronic signature.


Ensure integration with existing learning and HRIS systems

Next to the complexity of each department, we also see another commonality within the industry: a globally used learning and HRIS system – and sometimes even multiple learning systems.

AG5 integrates with any HRIS and learning system to ensure alignment with existing systems and processes. Our skills management platform connects with your HRIS and learning system, so you can avoid manually inputting learning and HRIS data.

AG5 can also provide two-way integration with your organization’s learning system. Here,  learning data is synchronized with AG5, so training managers can manage all training requirements within their role structures. They can also assign automatic training within the learning system when a training requirement has been defined within AG5. Additionally, when a training is completed, it will be synchronized with AG5 to ensure traceability and visibility of training compliance within skills matrices.

This automation is a key solution that many FDA-compliant organizations use, because it eliminates the manual task of assigning the proper learning to the employees in a timely manner. It also avoids mistakes within data due to human error.

AG5 integrating with other systems

Achieve FDA training compliance with AG5 Copied

Training compliance is difficult, especially for global or large organizations.

  • We have seen organizations that must meet global standards start with AG5, as well as those that do not
  • We have seen organizations start with AG5 while their organization was in the midst of a large-scale IT transformation
  • We have seen organizations start with AG5, even though they weren’t ready to use a centralized system

Why? They needed to meet regulatory requirements. This is one of the primary reasons that organizations start using AG5. Our experts help organizations set up a centralized skills management system, supporting them throughout the transition and implementation process to achieve organization-wide training compliance – not in years, but in months, or even weeks!

Want to see how this would work in your organization? Schedule a free, live, 15-minute demo for a custom look at how AG5 can help you achieve FDA training compliance.

AG5 skills management software

Sources Copied

Source title Description Date retrieved Source URL
Personnel qualificationsCode of Federal Regulations6 May 2024 16:38:49
Code of Federal RegulationsQuality System Regulations6 May 2024 16:40:47
Code of Federal RegulationsQualifications of individuals who manufacture, process, pack, or hold food6 May 2024 16:42:05
Code of Federal RegulationsQualifications of individuals who manufacture, process, pack, or hold animal food6 May 2024 16:43:12
Code of Federal RegulationsWhat training requirements apply to carriers engaged in transportation operations?6 May 2024 15:43:02
Code of Federal RegulationsElectronic records, Electronic signature6 May 2024 16:47:21

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Original version | May 13, 2024

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