7 Must-Have Quality KPIs Thank you to all who took interest in our ‘7 Must-Have Quality KPIs’ webinar with our partner, Process Stream. Our solution engineers took users through several facets of QMS reporting, and showed how to build these reports in real-time, giving practical ways for viewers to optimize their own quality data. Here are some of the topics we covered during the webcast: • The evolution of QMS and a platform overview • KPI delivery challenges and how to solve them • How to best leverage your QMS to run metrics • 7 essential KPIs (including global, site specific, and product specific) We’ve indexed the on-demand webinar into sections allowing you to navigate to exactly what KPI you want to see. THE 7 KPIs Below are what we define as ‘must-have’ quality-related KPIs for producing the most critical insights that impact your business. KPI #1: ON-TIME vs. OVERDUE (GLOBAL METRIC)Use-Case Scenario: As a Quality Representative, I want to monitor quality performance, unaddressed issues and frequently late issues at my company for every site. KPI #2: SITE COMPARISONS (GLOBAL METRIC)Use-Case Scenario: As a global Quality VP, I want to see which sites are performing best and apply those policies and procedures to my other sites. This promotes high quality and prevents FDA scrutiny. KPI #3: WORKFLOW & PROCESS STATUS (GLOBAL METRIC)Use-Case Scenario: As a Quality Manager or Director, I want to track the throughput of my quality events. Where can I reduce bottle-necks and quickly resolve issues with efficient processes that allow for the best use of man power across all of my sites? KPI #4: VOLUME (SITE SPECIFIC METRIC)Use-Case Scenario: As a Quality Manager or Director, I want identify the highest number of issues, what’s causing them and how I can fix them at my location. For example, if there are lot of procedural issues, maybe SOPs need to be revamped? Or, if there are training concerns, maybe my training program needs enhancement? KPI #5: PRODUCT & PROCESS CATEGORY TRENDS (SITE SPECIFIC METRIC)Use-Case Scenario: As a quality representative at a site, I want to monitor commonalities, root causes and the problem codes of my issues so I can put processes in place to prevent them from recurring. KPI #6: SUPPLIER QUALITY (BOTH)Use-Case Scenario: As a Quality or Supply Chain Manager, I need to identify high-risk vendors, and pre-approved reliable vendors. Vendor ratings are determined by credibility, delivery time, price and quality of the goods supplied so it is key to tie my quality events to my vendors when related. KPI #7: RISK ANALYSIS (BOTH)Use-Case Scenario: As a Quality Director, I need to evaluate risk across the entire organization and provide clarity to ensure risk has been mitigated. I want to create a collaborative approach for identifying, quantifying and mitigating product, operational and supplier risks that can impact quality.
BLOG How to Choose the Right MES or Manufacturing Operations Platform Selecting an MES or manufacturing operations platform is a strategic decision with long term implications. In pharmaceutical and biotech manufacturing, the platform chosen influences compliance, scalability, data visibility and the ability to continuously improve operations. Learn more
BLOG Improving Manufacturing Performance – Moving Beyond OEE to Operational Intelligence Overall Equipment Effectiveness (OEE) is widely used in pharmaceutical manufacturing to assess equipment availability, performance and quality. But in complex, regulated environments, improving performance requires more than retrospective metrics. It requires operational intelligence: Learn more
BLOG What is MES in Pharma Manufacturing? A Practical Guide Pharmaceutical and biotech manufacturers are operating in increasingly complex environments. Manufacturing Execution Systems (MES) have become essential infrastructure in this context. Learn more
BROCHURE TrackWise® Digital QuickTrack TrackWise Digital QuickTrack delivers the power of enterprise QMS without the complexity or cost—getting you compliant and operational faster. A streamlined solution and delivery approach designed specifically for startups, small, and medium-sized businesses. Learn more
BLOG Rethinking Life Sciences Quality & Manufacturing Operations in the Age of AI And Connected Systems Quality decisions in life sciences rarely fail because people don’t care. They fail when signals arrive too late, in the wrong place, or without enough context to act confidently. By the time an issue becomes a deviation, an investigation or even a recall, the early warning signs were usually there – they just weren’t connected, visible or actionable. Learn more
CASE STUDY Insud Pharma’s Journey with TrackWise Digital: Transforming Global Quality Management Insud Pharma shares how it transformed its global quality operations using TrackWise Digital QMS to standardize quality, document, and training management across manufacturing sites worldwide. Learn more
BROCHURE TrackWise® Manufacturing Operations Management Platform Transform Your Manufacturing Operations With Unified Digital Manufacturing Intelligence Learn more
BROCHURE TrackWise Manufacturing: Overall Equipment Effectiveness (OEE) Maximize Production Performance and Regulatory Compliance: With Real-Time OEE Monitoring & Analytics Learn more
WEBINAR Unlock the Power of EUDAMED for Enhanced Compliance and Efficiency Are you ready to revolutionize your approach to regulatory compliance? Don’t miss our on-demand webinar where we dive deep into the essential features of EUDAMED that can transform your compliance strategies and boost your operational efficiency! Learn more
WEBINAR Using Innovation to Accelerate & Optimize Your Drug Manufacturing Scale-up Strategy This webinar explores how innovative technologies and strategic approaches are transforming the pharmaceutical manufacturing landscape, enabling companies to accelerate their scale-up processes while optimizing quality outcomes and achieving critical success metrics including operational efficiency, regulatory compliance, supply chain resilience, and enhanced manufacturing experience. Learn more
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