The Value of LMS in Driving Effective Risk Mitigation Principles through QMS and QRM

When pharmaceutical companies implement their quality management system (QMS) and quality risk management (QRM), they recognize compliance, quality, and business performance benefits. Regulatory authorities, however, are increasing the pressure on demanding a risk-based approach to the entire product lifecycle (1). Over the past few years, their focus and attention on this objective can be seen in the volume of topic specific documentation posted on FDA’s website. That pressure isn’t going to diminish any time soon. So how do growing pharmaceutical and medical-device companies avoid inadequacies and redundancy in their critical quality system and risk management planning?  The answer lies in how well the learning management system (LMS), and the strategy beneath it to the QMS and QRM, are aligned.

When FDA set forth its QMS-related regulations, the objective was for pharmaceutical companies to understand that by implementing a comprehensive quality systems model, it would allow manufacturers to support and sustain robust, modern quality systems that are consistent with CGMP regulations. It would also enable manufacturers to implement a quality system in a form that is appropriate for their specific operations. A quality system can provide the necessary framework for implementing quality by design, continuous improvement, and risk management in the manufacturing process. Now FDA expects the implementation of its risk-based requirements across the entire product lifecycle (2). This puts increased pressure on an organization to ensure that more people must have access to critical knowledge and the proper training to uphold these growing FDA requirements. This is most true in reference to the key areas of management responsibilities, resources, manufacturing operations, and evaluation activities. The crucial nature of ensuring the best management and sustained compliance across those four key areas leads back to the implementation of a strong learning strategy, including a robust LMS, across the global organization.

But what is the nature of the LMS with regard to the QRM? The two share the role as enablers of a strong QMS. They both ensure that the role and responsibilities of a QMS, from a quality and compliance perspective, are maintained and managed. In essence, a QRM should be able to identify, analyze, evaluate, reduce, accept, and finally, review events surrounding risk-as part of the quality risk management process (3). When the flow of a sound QRM is taken into consideration, it is understandable that a single-source LMS serves to aid in risk mitigation by serving as the primary repository of knowledge to train and empower responsible personnel.

Keeping compliant

The current path for many global life-science companies includes the push for high growth and expansion to keep up with regulatory compliance demands and the development of products and/or technologies to remain competitive. Every aspect of these fundamental business demands results in layers upon layers of knowledge, processes, systems, requirements, and a complex honeycomb of training to keep up with both new personnel, existing staff, and industry requirements. The inevitable risk management issues that will arise from all of these mission-critical activities brings with it a tide of management pressures on both the leadership and the organization. Needless to say, it is overwhelming to even the most efficient.

Keeping ahead of the tide requires more than a shift away from paper-based QMS, a responsible QRM, and basic compliance training. At the heart of mitigating risk and remaining competitive in todays’ extremely fast-paced life-science industry is the knowledge that internal teams have the right tools to develop the best strategy and then deploy it. The inertia that drives this positive outcome is managing the immense girth and depth of an organization’s assets and knowledge. If companies cannot command the universe that is the knowledge base, it is basically impossible to leverage the value of it to become or remain an industry leader. It truly is what you know that will positively set an organization apart.

It is not surprising then that some of the following questions haunt pharma and device company leadership with regard to how their QMS and QRM are supported through their LMS:

• Is our immense body of knowledge actually accessible and disseminated to our employees, customers, and partners properly?

• Does our strategy and system ensure we are meeting industry required job roles, supporting professional growth, and fostering employee retention?

• Are we managing risk and compliance, as well as change control documentation through our current system?

• Are our disparate learning management processes raising risks and increasing regulatory scrutiny?

• Does our system properly manage tech-transfer responsibilities, especially in the event of an acquisition?

• Are we moving beyond compliance and qualification to ensure competence and performance, in order to drive our bottom line?

The issue of which LMS is right for each organization has become a hot topic as part of the larger QMS and QRM discussion. The right learning management strategy and actual system is not so much a product of how the QMS and QRM are structured, but the other way around. Companies rarely set out to ensure regulatory compliance across their product line, manufacturing, operations, and customer relationship management through their LMS, but why not? Ultimately, it is dependent upon the leadership team to consider the immense potential a strategic global LMS has in ensuring that teams, the QRM, and QMS are fully enabled and effective.

Choosing the right LMS

So where does an organization begin? To determine the right learning management strategy and which LMS is ideal for the organization, it is wise to always refer back to the criteria put forth by FDA and the International Organization for Standardization (ISO). Per the ISO 9000 series of guidance and recommendations around the development and implementation of a QMS, there is a tremendous amount of valuable data that can be leveraged in assessing what and how to include in an LMS strategy for both employee development and compliance requirements.

Fundamentally, each of the questions stated above become non-issues once the right learning management strategy and LMS are properly deployed and managed. Ideally, it is wise to bring an independent third-party organization in that can provide the expertise needed. They can ensure that an unbiased assessment of where the company is vs. where it needs to be with its learning strategy and LMS, along with credible solutions to choose from. It’s not a simple process by any means, but it will not become any less a demanding scenario either. In essence, if an appropriate strategy and plan for managing and mitigating risk through the LMS isn’t deployed, an organization could end up on the wrong end of an audit (4).

An integrated, a cloud-based LMS is highly advised, because of the need for compliance and performance as well as the management of the infrastructure and content. All training courses, updates, and content management of the knowledge base can be better managed through a digital solution. Prior to selecting the right single source enterprise-wide LMS, an organization can take the following critical steps to aid in the planning and selection process:

• Bring in a knowledgeable learning management partner or consultant to perform a needs evaluation and requirements definition.

• Assess the current learning management strategy and identify gaps, such as compliance risks and lack of effectivity, that will impact the migration for migration from current state to future state.

• Review organizational design, role-based employee development, technical competency, use of technology for record keeping, training/onboarding process, and program governance.

• Evaluate content for training and development-including systems, platforms, related support, optimization, validation, integration with other systems, and data migration services.

• Gauge any new requirements, industry standards, compliance issues, training demands, and competitive issues/opportunities that may be affected by the LMS.

• Define a list of business requirements that encompasses the unique and complex compliance, learning, and performance requirements across the diverse organization.

• Develop a project roadmap that aligns existing to new, defines key stakeholders, outcomes, steps, content required, tech transfer, governance strategy, and alignment of employee development.

• Update operational strategy, program management, process redesign, data migration, systems integration, system validation, and content hosting.

• Prepare an implementation plan and timeline.

• Award and launch project, inclusive of all pre-go live activities and preparations.

Creating a truly integrated and enterprise LMS that both fuels and contains both the QRM and QMS as well as the non-GxP training activity is no longer a lofty objective. It is becoming a fundamental shift in the way life-science organizations will need to organize and manage day to day activities, as well as requirements. Creating a competitive advantage and increasing customer retention are all built in aspects of the knowledge base-and as such, the LMS. An organization’s body of knowledge is an essential resource for employees, customers, and partners. Therefore, proper access and maintenance is essential.

Conclusion

Investing in a single source enterprise-wide LMS to fuel risk management and mitigation offers multi-dimensional return on investment. There are key issues like mastering enterprise-wide change control and associated documentation to setting corporate roadmap milestones to remain competitive. The value of efficiently managing training requirements and content to ensure role-based qualification and competence is immense for both employee and employer, not to mention the human resource recruiting advantage. An LMS is even a mission-critical element for business expansion. There are numerous recognized and proven solutions available, once an organization is prepared to take advantage of leveraging their LMS as a more essential part of their infrastructure.

References

1.     FDA, Final Report on Pharmaceutical cGMPs for the 21st Century-A Risk-Based Approach, updated Dec. 17, 2014.

2.     FDA, Guidance for Industry, Quality Systems Approach to Pharmaceutical CGMP Regulations (CDER, September 2006).

3.     FDA, Pharmaceutical Quality Systems (ICH Q10) conference, Nov. 16, 2011.

4.     ISO, Selection and Use of the ISO 9000 Family of Standards, March 2016.