07.9.2019 Robert Fenton

The Anatomy of a Healthy QMS for Life Sciences Companies

Ready to move on from a paper, hybrid, or legacy quality management system?

Quality management system (QMS) software built specifically for life sciences companies can be an asset which helps you comply with regulations and improve the quality culture of your organization.

Life sciences organizations are facing many pressures to get quality management right. Regulatory compliance is the top concern for FDA-regulated organizations, according to a recent study, followed by the need to succeed with cost control and achieve superior product traceability. A QMS explicitly designed for your industry and regulatory requirements can ease your compliance stress without the need for extensive configurations.

But how do you know a great life sciences QMS when you see one? What's the difference between a generic QMS which is only marketed as a vertical solution, and an eQMS designed specifically per cGMP, ISO, and other important standards?

With the right tools in place, you can move to the top of your market and grow your business. The right technology can align people and process to help you reduce regulatory risk, maintain an audit-ready state, and compete in tough market conditions. We’ll show you what a first-rate QMS for life sciences looks like by identifying a few key elements to search out.

Five Components of a Healthy QMS for Life Sciences Companies

QMS technology for the life sciences industry is software which helps organizations achieve compliance with regulatory requirements, while creating a culture of continuous improvement.

A healthy QMS for life sciences companies can also address industry-specific challenges. Forty-seven percent of life sciences organizations identify quality management issues as the top barrier to new product introduction. Twenty-five percent struggle with scaling processes, equipment, and systems to meet production requirements or company growth. The right QMS is tailored to your organization's vertical and right-sized for your needs, size, budget, and growth goals.

There are several QMS components and features you should never compromise on, regardless of whether your organization is a multi-national enterprise or a small, fledgling startup. You especially need these features if your organization is pre-market approval and considering a first-time QMS implementation. Having strong capabilities for document management, training, quality events, and closed-loop measurement can create a strong base for regulatory approval and compliant growth.

Document Management

Your organization has no shortage of choices when it comes to implementing a document management solution. To meet FDA cGMP, you have the option of maintaining paper records or using a stand-alone document management system which integrates with other solutions or modules for quality management.

Compliance isn’t the only component to think about when it comes to document management, however. Consider ease-of-use and collaboration to identify a healthy QMS for life sciences companies.

  • Does the solution offer easy, quick, user-friendly keyword searches for documents?
  • Is document management integrated with other quality management processes?
  • Is the solution enterprise-grade without being confusing or needlessly complicated?
  • Does technology enable collaboration or act as a barrier to productivity?

If a document management feature has rigid processes or limited tools for collaboration, it may complicate global work processes at your organization. Don't let yourself get caught up in the sophisticated, unnecessary features of some systems and lose sight of what matters. A document management tool should support your organization's quality processes and make it easier for stakeholders to collaborate.

The must-have capabilities include:

  • Document drafting, review, and approval
  • Collaboration features for in-line commenting and editing
  • Cloud-based access for a global workforce
  • Automated reminders to streamline approvals
  • Role-based access and audit trails
  • FDA CFR Part 11 compliant digital signatures

RELATED READING: 4 Part 11 Compliant Document Management Systems You Should Know About

Training Management

Your life sciences organization must demonstrate compliance with cGMP training requirements. A healthy QMS should support this need and provide strong learning management capabilities.

Knowledge is empowerment, and highly trained staff is better prepared to comply with SOPs and participate in continuous improvement activities. The training management capacity of a life sciences QMS should meet regulatory approval and the needs of your personnel across departments, including your talent in HR, leadership, sales, marketing, product development, manufacturing, and QA/QM roles.

Some key training management capabilities to look for include:

  • Role-based training functionality
  • Audit trails on training completion
  • FDA compliant digital signatures on assessments
  • Robust data security and record protection
  • Secure integration with document management
  • Event-based training capabilities
  • Visibility to track training progress
  • Assignment-based training functionality

Your training management capabilities should act as a window into the progress and learning activities of your whole workforce. Consider whether a QMS simplifies your goals of exceeding compliance requirements and achieving a quality-driven business. The best systems offer advanced capabilities to streamline operations, like the ability to assign training to a staff member in response to quality events or CAPA.

To see some of the training management capabilities of our QMS, check out our Basic Training and Reporting Guide.

Quality Events

At a minimum, a life sciences system should offer the essential capabilities to centrally manage all quality events which can occur during the product lifecycle. This includes non-conformances, deviations, and customer complaints.

It's critical to consider quality event capabilities when evaluating a QMS, even if your organization is in the research & development stages of taking your first product to market. Having stable quality event features can simplify your process for managing quality processes.

Quality events should be integrated across complaints, CAPA, deviations, and non-conformances and integrated with the rest of the quality systems to streamline corrections and improvements. A quality event should trigger necessary changes in document control, risk management, audit, or training, depending on the root cause analysis results.

To see some of the quality events capabilities of our QMS, check out our Quality Events Overview.

Product Development

Organizations in the life sciences industry have much different approaches to product development than other verticals which rely on QMS, such as manufacturing. Highly-regulated life sciences organizations are unique because R&D can work for years without marketing or product management professionals to bring a product to market approval.

If product development documentation is non-compliant, it can easily spell issues gaining approval to market, excess costs, and loss of competitive advantage. Product development features are critical in any life sciences QMS, but they may be especially crucial at small, R&D-driven organizations.

A QMS designed specifically for life sciences can introduce product management and compliance earlier in the development lifecycle. It can simplify the process of compliant product development documentation in highly regulated industries, including medical device organizations that face particularly steep documentation requirements under ISO 13485.

Evaluate whether a QMS system makes it simple to comply with industry requirements for product development documentation, even if you're facing several years of R&D.

RELATED READING: The Keys to Successful Life Sciences Product Development

Closed-Loop Quality

A healthy QMS for life sciences should close the loop on your quality management processes by providing a single, centralized portal for total quality management. This should include the core organizational processes like training and quality events, as well as the other “spokes” of your system--including audits, suppliers, and change management.

Closed-loop systems offer benefits of superior data quality and visibility, and they can also make it much simpler to respond to quality events and risks in real-time when non-conformances are discovered--as opposed to waiting for a customer complaint or CAPA event.

Consider whether a QMS offers triggered events for change management, based on the detection of quality events or management review. Does an update to a single SOP make it simple to understand the impact throughout your entire system? Do risk management and analysis features allow you to identify the actual root cause of quality issues, instead of just putting a bandaid on a symptom of quality issues? Closed-loop QMS features are a necessity to achieve a genuinely quality driven culture.

Dive Deeper than Compliance for Life Sciences

As a life sciences organization, you have many choices when it comes to selecting the best QMS. You can choose a generic QMS system and invest heavily in configuration to meet compliance requirements and ISO standards. You can choose to integrate a series of stand-alone systems, or you can seek out a QMS that is right-sized for your industry and business needs. Looking beyond pure compliance to understand how the five critical elements function is essential.

When you are evaluating solutions, don’t treat features like Quality Events or Training as a checklist. Get demos from prospective vendors to understand how these features can enhance quality at your organization. For example, do product development features make it easy for individuals who aren’t in dedicated product manager roles to take a product marketing mindset and create compliant documentation? The healthiest QMS options for life sciences simplify continuous improvement and risk management. Schedule Your Free Demo Today

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Published by Robert Fenton July 9, 2019
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