Strike the Right Balance between Compliance and Quality August 3, 2021 A focus on compliance is necessary for Life Sciences companies. Complying with regulations is a core part of their ‘right to operate’, making it possible for them to manufacture and sell their products. But manufacturers that focus exclusively on compliance at the expense of other core quality objectives put themselves at significant risk. A compliance-only focus risks failure in other quality areas such as product quality, safety, efficacy and continuity of supply. They may also lose sight of the goal, which is delivering safe, effective, high-quality products to the market quickly and consistently. Manufacturers that balance compliance with a broader set of quality objectives, contributing the necessary resources to each area, are much more likely to achieve all key objectives at the same time. Here’s how you can do the same. Identify the Right Key Performance Indicators (KPIs) When it comes to measuring performance, companies often strive for a “balanced scorecard”—where the internal functions of a business are achieving the desired external results. However, in quality operations, if a manufacturer’s scorecard is focused solely on compliance, then it is inherently out of balance. The measures do not sufficiently address core quality objectives: Product quality Product safety Efficacy Continuity of supply Compliance In other cases, a manufacturer may develop KPIs that measure the efficiency rather than effectiveness of its operations. Measuring how fast a task is completed is far easier than measuring whether an action had an impact on product quality and safety. To strike a balance between quality and compliance, Life Sciences manufacturers must establish KPIs that go beyond checking a compliance box. These KPIs must get down to the root cause of quality issues and measure how effectively the company addressed them. Given the increasingly outsourced Life Sciences supply chain, companies must also have KPIs focused on supplier quality performance. Manufacturers with KPIs that balance compliance with quality have the insights necessary to address all five quality objectives. Furthermore, quality teams can show executive leadership that their role goes well beyond compliance scorekeeper, and they can impact organization-wide performance. Foster a Culture of Quality In order to balance compliance and quality, a manufacturer must build a culture of quality within its organization. This is more than the culture of the quality group itself—it is the culture of the entire organization, including third parties. It means that every group and individual that plays a role in the product lifecycle understands the importance of quality and is committed to advancing it. It is not enough for the C-suite to say, “We must focus on quality,” or for the company to invest in advanced technologies for quality management without first investing in its policies, people, processes and data. Life Sciences manufacturers must build a framework that infuses quality into each aspect of their operations. Establish a Framework for Quality and Compliance Manufacturers must have a comprehensive framework in place that establishes and maintains a culture of quality throughout their organizations and extends out to external business partners. A critical component of this framework is a balanced scorecard with KPIs that measure quality improvements, rather than compliance checklists. Download the white paper to learn key elements of a framework Life Sciences manufacturers can use to mitigate risk, drive the development of safe, effective products and satisfy regulatory requirements. DOWNLOAD WHITE PAPER
CASE STUDY ABF-Pharmazie’s Journey with TrackWise Quality, Document and Training Management Hear why ABF-Pharmazie selected TrackWise to manage their Quality, Document and Training Management. Learn more
CASE STUDY Philips Healthcare ‘Made the Impossible, Possible’ with the help of TrackWise Marvel at how Philips Healthcare 'Made the Impossible, Possible' with the help of TrackWise. Learn more
EBOOK Life Sciences Industry Insider: Product Quality Ever wonder how TrackWise can help IT leaders in Life Sciences drive greater operational efficiency? Learn More. Learn more
WHITE PAPER Turning Quality Review Processes into Insights & Efficiencies through Business Applications The life sciences industry is evolving fast—those who harness data and adapt to complex regulations will lead in quality, safety, and market growth. Learn more
INFOGRAPHIC Life Sciences Recalls: Causes, Implications, and the Path Forward What is driving product recalls in life sciences? Here’s a quick breakdown of the most common reasons across medical device, pharmaceuticals, and biologics. Learn more
BROCHURE TrackWise Recall Management Datasheet Empower Your Recall Strategy: Drive Efficiency, Compliance, and Patient Safety Learn more
WEBINAR Transforming Compliance into Performance- A New Approach to Quality Reviews This webinar explores how new innovative solutions can transform traditional quality management processes into a source of operational performance, leveraging a unified, intelligent data ecosystem. Learn more
EVENT 2025 Interphex Week Osaka Join us at Japan's leading exhibition for pharmaceutical industry. Learn more
CASE STUDY Voice of Customer: Rahul Songire – Senior General Manager, CQA, Zydus | Digital Transformation Journey with TrackWise QMS Discover insights from ahul Songire - Senior General Manager, CQA, Zydus, as he shares his experience with TrackWise and its vital role in data analytics, highlighting how it saves time and enhances efficiency. Learn more
CASE STUDY TrackWise Digital video testimonial from Barry Cook, VP of Quality Operations – McKesson "I use quality and simplification pretty much hand in hand. All of us as quality professionals, we have big problems to solve and lots of regulation to navigate." Learn more
CASE STUDY Olympus | Digital Transformation journey with TrackWise Quality Hear how Olympus is standardizing, simplifying, and harmonizing to be efficient and compliant globally, with Honeywell Life Sciences. Learn more
CASE STUDY Voice of Customer: Suruchi Sharma, Regional Quality Manager @ Abbott | Experience with TrackWise Quality "They understand what we need, and they come up with a solution to that." Learn more
CASE STUDY Voice of Customer: Jagdish Meghrajani, Senior Manager IT @ Zydus, | Digital Transformation Journey with TrackWise QMS "TrackWise helped us to implement all the modules easily along with required IT infrastructures and helped us to harmonize the process across sites." Learn more
CASE STUDY bioMérieux | Quality Transformation journey Leading global diagnostics company, bioMérieux, started with TrackWise QMS and later transitioned to adopt TrackWise Digital. Hear more about their digital transformation journey and how our solutions foster trust, collaboration, and innovation in life sciences. Learn more
INFOGRAPHIC Automate and Visualize Batch Production | Elevate Efficiency and Quality TrackWise Experion Batch empowers Life Sciences manufacturers with advanced visualization, real-time data integration, and distributed batch control. Optimize productivity, ensure compliance, and maintain product quality with proactive decision-making and real-time alerts. Learn more