Is Your Quality Management System (QMS) Keeping Up?

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Your ability to thrive in a quality-centric culture hinges on having a robust Quality Management System (QMS) that consistently delivers on your business objectives through reliable processes and data. However, even a QMS built on solid foundations can quickly become outdated in our ever-evolving pharmaceutical industry without regular reviews and upgrades. An antiquated QMS isn’t merely a frustration; it poses a risk to your business’s heartbeat and desired outcomes.

Navigating the Landscape of Process Optimization

Your Quality Management System is the compass for continuous improvement, ensuring regulatory compliance and ingraining quality into every facet of your business. To fulfill these essential roles, your QMS should:

  • Ensure consistent batch-to-batch excellence.
  • Empower your organization to exceed expectations by establishing standardized processes, procedures, and controls.
  • Ensure compliance with international regulatory requirements.
  • Identify and rectify errors promptly to minimize rework and increase operational efficiency.
  • Streamline supplier onboarding to achieve complete supply chain visibility and facilitate scalability.
  • Provide valuable data and insights for data-driven decision-making and fostering a culture of continuous improvement.
  • Aid your team in evaluating, mitigating, and managing risks associated with processes, products, and regulatory requirements.

According to Stephanie Gaulding, Managing Director, Pharmatech Associates, for those companies wanting to move from an embedded QMS model to a higher standard, it comes down to a self-driven desire to be the best and redefine what quality means.

“[These companies] want to be out there adopting innovative technologies and solutions. They’re out there finding new ways of doing things,” says Gaulding. “And fundamentally, quality is not just an attribute anymore. It is a value. It is embedded in everything that the company does.”

To hear more from Gaulding and Pharmatech Vice President of Regulatory Compliance Mike Porter, tune into our webinar, The Difference Between Compliance and Quality

The Fallout of a Shaky QMS

When your QMS isn’t performing at its peak, the consequences are more than operational. Inefficiencies can lead to drug development research stagnation, delays in drug product launches, and internal impacts on workforce morale and productivity. Dissatisfied customers, the inability to secure top-tier contracts, and a decrease in market share can follow suit.

Case in Point: Risk-Based Oversight of GxP Suppliers
 A late-stage clinical drug sponsor needed to overhaul their supplier oversight program and establish a centralized, risk-based process. To encompass the various requirements for GLPs, GCPs, GMPs, and GVPs, Pharmatech consultants stepped in to develop a centralized framework for supplier onboarding that included GXP-specific forms, checklists, and guidelines for supplier evaluations and audits, along with a series of other improvements. The result: The client achieved full visibility of their suppliers and the ability to tailor oversight requirements based on risk levels, which facilitated scalability as their drug products progressed through development.


Where do you need to look to ensure that your QMS keeps up with your business needs?

  • Addressing Efficiency Gaps in LIMS

One key area for QMS enhancement involves identifying gaps in your Laboratory Information Management System (LIMS). You can gain cost savings, better decision-making, and improved product quality by pinpointing bottlenecks and determining new ways to optimize workflows.

  • Enhancing CAPA Systems

Maintaining an efficient Corrective and Preventive Action (CAPA) system is another element vital for QMS improvement. You’ll want to focus on:

  1. Root Cause Analysis (RCA) to identify and address underlying issues.
  2. Risk Assessment to mitigate risks associated with the CAPA system.
  3. Employee training for effective CAPA system implementation and maintenance.
  4. Internal audits to ensure compliance with regulatory requirements.
  5. Documentation of standard operating procedures (SOPs), forms, and templates.
  • Meeting International Regulatory Requirements

Regular evaluation of regulatory and customer requirements is integral to improving your QMS. It ensures legal compliance, enhances product quality and safety, manages risks, satisfies customer expectations, supports global market access, and fosters a culture of continuous improvement.

  • Continuous Improvement

The effectiveness of a QMS adheres to the philosophy of Continuous Improvement. As laboratory systems and processes undergo digital transformation, Continuous Improvement demands you constantly identify and improve gaps, assess, and improve CAPAs, and meet evolving regulatory and customer demands to stay ahead of your competition. A resilient QMS is more than a mere framework; it fosters a quality culture centered on customer satisfaction, employee engagement, and essential QMS principles tailored for the heavily regulated pharmaceutical industry.

The Pharmatech Factor

Pharmatech’s seasoned team excels in Quality Management System optimization. As a strategic partner, we delve deep into understanding your processes. Utilizing the Integrated System of Quality Management model, our proven strategy addresses processes, documentation, monitoring, compliance, procedures, training, review, and risk mitigation. This holistic approach ensures a streamlined and elevated QMS and demonstrates our commitment to delivering impactful results.

At Pharmatech, we’re in it for the long haul. We’re here to guide and advise you in navigating and excelling in this competitive, often complex arena. Your QMS is more than process, it’s the compass guiding your organization and we’re here for every step of your journey.

Call Pharmatech today to review your QMS, identify any gaps you may have, and make sure it keeps up with your business goals.

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