May 27, 2021

Life sciences companies including developers and manufacturers of medical devices and technologies, IVD and pharmaceutical products and biologics must implement and maintain quality managements systems (QMS) such as ISO 13485:2016 or US FDA 21 QSR Part 820 to safely bring products to market in compliance with strict regulatory requirements.

Being a highly regulated industry, life sciences companies must ensure adherence to QMS and Good Manufacturing Practices and processes via effective training and education of quality assurance, manufacturing and other personnel. Such training is managed and conducted using learning management system (LMS) software, which in addition to providing more efficient and automated training methods and processes for manufactures, also promotes risk mitigation in terms of ensuring more educated and proficient personnel—which can prove crucial for avoiding costly and potentially dangerous errors in rapid production of new vaccines and medical technologies, for example, during public health emergencies.

Deploying an LMS in the context of both enhanced training capability as well as risk mitigation yields benefits for life sciences companies regardless of scale, but such an implementation requires careful consideration of various factors:

  • A manufacturer’s long- and short-term goals in terms of risk management and mitigation;
  • Which quality management system(s) a manufacturer has implemented, or plans to implement;
  • Specific markets in which a company operates (and therefore, which regulations beyond QMS requirements affect compliance);
  • Degree to which a manufacturer relies on automated versus manual processes across its enterprise.

Risks of reliance on manual training and education practices

Although senior managers at some medical device, IVD and pharmaceutical manufacturers may consider risk management efforts as separate from employee training and education, recent developments involving COVID-19 vaccine production in the US help to illustrate how inadequate training processes may lead to manufacturing practices out of sync with quality assurance.

In turn, these shortfalls in training processes can ultimately result in serious, long-term consequences for a company:

  • Interrupted or delayed production output;
  • Damage to brand reputation;
  • Increased scrutiny and potential penalties from market regulators;
  • Negative impact on long-term growth.

Although no silver bullets exist to easily address the risks listed above, utilization of LMS platforms closely aligned with a company’s QMS parameters, and that supports compliance to related electronic record maintenance regulations such as US FDA’s 21 CFR Part 11 and the European Union’s Annex 11, enables manufacturers to demonstrate compliance as well as keep employees up to date on complex and ever-changing regulatory requirements. Ensuring that employees involved in mission-critical functions have undergone all necessary and up-to-date training regarding their assigned processes helps avoid potentially damaging operational as well as reputational risks.

LMS as competitive advantage?

Of course, implementing a digital LMS at the enterprise level provides the clear benefit of streamlined and automated training capabilities, but companies should consider less immediate, longer-term advantages of adopting these technologies not only in terms of training and compliance, but also in support of more robust risk management and competitive advantage—more comprehensive and efficient training capabilities translate to more effective business decisions and performance.

Again, however, much depends on implementing an LMS whose feature set and capabilities best align with a manufacturer’s structure, operations and growth plans. Crucially, manufacturers should consider LMS offerings that provide not just robust feature sets, but also scalability to support firms’ evolving QMS requirements as their operations expand.

In our next blog post covering LMS support for life sciences companies, we’ll examine key features of LMS software offerings and how they apply to manufacturers’ training and compliance requirements.

Mike Lawrence is Head of ComplianceWire Product Management at UL.

Learn more about LMS technologies to support the life sciences industry

  • UL ComplianceWire® LMS support for life sciences companies and manufacturers

 

 

Author

  • Mike Lawrence and Stewart Eisenhart

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