Quality innovation for a brighter future

A lack of technological unity can have a profound effect on an organization’s ability to function. Keeping key business elements in silos creates friction points and blind spots that affect an organization’s performance at every level.

Technology can play an important role in addressing the challenges of complaint handling in regulated industries, such as pharmaceuticals and medical devices.

The benefits of enabling Quality by Design with AI-driven quality operations include connecting AI-enabled quality management and batch automation to provide real-time visibility, using real-time critical process parameter alerts to provide early detection, and more.

Sparta Systems, a Honeywell company, was proud to be a platinum sponsor of this year’s Virtual European QA Congress.

Recalls are more than just a setback; they can be a multidimensional storm of financial loss, public health risks and reputational damage. Learn how Life Sciences companies can fortify their defenses against these disruptive events.

The strategic partnership brings forward next-level IoT and AI capabilities in order to cut investigation and product release cycle times and reduce wastage by identifying quality risk before nonconforming product is generated.

A quality management system (QMS) can assist with risk assessments by automating the risk assessment process.

Hear why ABF-Pharmazie selected TrackWise to manage their Quality, Document and Training Management.

Streamline new product delivery with a robust quality management system (QMS). Discover how a QMS enhances collaboration, process efficiency and real-time visibility for accelerated product development.

How to shift from reactive to proactive quality management and meet FDA software requirements FDA leaders have acknowledged that artificial intelligence (AI) and machine learning (ML) can improve performance and spur innovation. Dr. Scott Gottlieb, who served as the FDA’s commissioner until April 2019, said it could even lead to the development of novel medical…

Integra is a very large company with multiple manufacturing sites. We have about 15-16 manufacturing sites globally. So right now, we have a lot of processes that manage our quality system. TrackWise Digital gives us the opportunity to standardize all these processes.

Since the launch of Honeywell’s Manufacturing Excellence Platform in October, we’ve enjoyed reading positive comments from customers and colleagues across life sciences manufacturing.

To reduce harm to patients and users, quality risk management must successfully integrate with the quality management system.

By understanding the new MDR, medical device manufacturers can get ahead of the curve and keep headaches—and compliance costs—to a minimum.

Conducting a root cause analysis (RCA) is an essential problem-solving method used to isolate and identify concerns. RCA goes beyond simple cause and effect to identify failure points in a process or system.

In complex, regulated environments, improving performance requires more than retrospective metrics— it requires operational intelligence.

The EU Medical Device Regulation was pushed back a year. What do you do? We interviewed Sparta Systems project managers for their perspectives.​

A supplier quality management cloud-based solution offers a central portal to stay connected with suppliers and ensure supply chain resilience when customers and patients need us most.

Continuous improvement increases productivity, profit, and customer satisfaction and creates less waste. In this article, Sparta's Zillery Fortner shows us how the PDCA cycle supports continuous improvement.

The evolution of cloud-based quality management systems is transforming expectations and changing realities in the life sciences industry. Find out how in our latest newsletter edition.

Learn how quality leaders can build a practical business case for AI by focusing on efficiency, visibility, compliance and operational performance outcomes.

Reducing Total Cost of Ownership (TCO) is about not only software licensing but minimizing complexity across the full lifecycle of manufacturing operations.

What do football and corrective and preventive action (CAPA) have in common? More than you may think. As the Philadelphia Eagles and the Kansas City Chiefs prepare for this weekend’s big game, let’s consider how the CAPA process in quality management can be compared to these teams’ game strategy.   In both football and quality…

Sparta’s Quality Process Accelerators (QPA): Quality management solutions that are intuitive, simple to use and encourage user adoption.

Recaps of virtual event sessions from the annual customer conference, Sparta Connection 2020

If you have been struggling with corrective and preventive action (CAPA) management, it’s possible there is a tech solution that will lift the burden.

Are you still managing quality with a legacy quality management system (QMS)? If so, you may be faced with less efficiency, higher costs and other downfalls that you may not have considered.

At the Q1 11th Annual Medical Device Supplier Quality Assurance Conference, Sparta’s Zillery Fortner presented her topic “How to Establish Supplier Qualifications.”

Nucleus Research names Honeywell a Leader in the 2026 QMS Technology Value Matrix, recognizing TrackWise Digital’s life sciences quality capabilities.

Quality failures can harm any business, leading to product recalls, dissatisfied customers, damaged reputation and financial losses.

The benefits of remote supplier audits include lower costs, no travel restrictions, no logistical constraints, better use of resources and the ability to continuously monitor suppliers.

Explore how artificial intelligence is helping life sciences organizations improve investigations, CAPA management, complaint handling, risk management and quality knowledge discovery.

Quality data have a direct impact on operational and economic performance in various areas - from research and development (R&D) to manufacturing, to the supply chain.

With many manufacturers focused on managing costs, you need a strong business case for any QMS investment.

Mature solutions can ease exceptional change. With the unprecedented challenges that manufacturers are facing during the COVID-19 pandemic, quality management might be the last thing on your mind. 

Understanding AI Beyond the Buzzword But before we dive into how AI can be used; what does it truly mean?

The 2019 Sparta Systems Pharma Outlook Survey revealed top goals and challenges for pharmaceutical quality teams as they enter the new year.

Hear from Sheetal Mane, Lead IT Quality at Piramal, as she discusses their journey with TrackWise, transforming operations across 16 sites. Explore their transition from paper-based to digital processes and thoughts on TrackWise Digital for enhanced efficiency.

Reduce complexity and improve visibility using TrackWise Digital QMS to unify and standardize data and processes.

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 how Philips Healthcare 'Made the Impossible, Possible' with the help of TrackWise Quality.

Watch a video testimonial from Shawn McKinley, Senior Analyst, Information Systems – Cambrex.

Implementing a quality management system (QMS) can be a transformative journey for organizations, enabling them to enhance product quality, streamline processes and drive continuous improvement.

As manufacturing operations and supply chains expand globally, quality management systems (QMS) need to match their flexibility, speed and integration.

Productivity and profitability: Two words that are constantly at the forefront of every manufacturer’s mind. How can I make my operations, systems, and processes more productive and profitable? What new tools are available to help improve productivity and increase profitability?

Not all companies that are compliant have good quality, but companies with good quality are typically compliant.

Strengthening OT cybersecurity in life sciences is critical to help mitigate digital transformation risks, take steps to protect operations and comply with evolving regulations.

Mind mapping is a great way to evolve your team's thoughts and bring them to life to spark the creative thought process of finding solutions to problems.

The digital revolution has changed the way many global life sciences manufacturers approach quality management.

Find out more about Sparta Systems' participation at the 5th Annual European Medical Device and Diagnostic Supplier Quality Management (SQM) conference in Brussels, Belgium.

Medical product manufacturing companies are required to compile and use quality metrics to assess the quality, safety and efficacy of their sites and products. However, such metrics do not currently need to be routinely reported to the FDA.

Regardless of industry or company size, all Quality leaders share these five key imperatives.

Learn how connected quality data and AI-powered insights help life sciences organizations move from reactive compliance toward predictive quality management.

Honeywell has introduced the TrackWise® Life Sciences Platform, a purpose-built solution designed to revolutionize the way life sciences organizations approach integrated manufacturing and quality management, through digital transformation and advanced automation.

Reducing Total Cost of Ownership (TCO) is about not only software licensing but minimizing complexity across the full lifecycle of manufacturing operations.

The FDA established the unique device identification (UDI) system to identify medical devices sold in the United States from manufacturing through patient use, which would ultimately modernize post-market surveillance.

AI delivers greater value when quality and operational data are connected. Learn why connected quality is the first step toward successful AI adoption in life sciences.

AI-enabled quality management systems can help organizations transform their quality culture and improve digital quality.

“I really much prefer taking this more customer-friendly approach, and let them own the data and ultimately own what they do with it.”

Discover a step-by-step approach to connected quality. Learn how life sciences organizations can connect data, improve visibility and prepare for AI-powered quality operations.

How does a QMS work - This comprehensive guide will delve into the core principles and functionality of a QMS, addressing the most common perspectives and needs that individuals may have when asking this.

Thank you to all who took interest in our ‘7 Must-Have Quality KPIs’ webinar with our partner, Process Stream.

Document management technology can be used by manufacturers in regulated industries, such as Life Sciences, to aid their communication with regulators in several ways. 

An automated change control system manages all action items associated with a change including impact assessments, implementation items, regulatory notifications, approvals and effectiveness checks.

Medical device companies need a solution that mitigates quality challenges with supply chain quality management, complaint handling and reporting processes.

Document management is the process of creating, storing and controlling documents that are related to the quality of the products being manufactured. Examples of these documents include quality manuals, procedures, work instructions and records of inspections, audits, and test results.

Elevating the role of the technology solution provider in service of the health and wellness of the global population

No matter what business you’re in, you may face regulatory requirements and third-party assessments of your quality management system.

How can organizations leverage data to get it right the first time and what is the cost of not doing so? In the latest episode of Sparta’s special series, Shaping the Future of Quality, we discuss this with Kathleen Brunner, President and CEO of Acumen Analytics. Tune in to learn the true cost of not being digitally smart and learn how to get it right.

Hear what the Celonic team had to say about their TrackWise Digital experience.

Many life sciences manufacturers have a growing interest in cloud-based quality management solutions. But the platform on which your QMS runs is as important as the QMS product itself.

This article aims to provide an overview of the key components of a QMS, with a specific focus on quality management software.

Why is a QMS important? Let's dive into the answer from experts who have been working on quality management for decades.

Did you miss it? Here are some highlights from Sparta’s expert sessions.

If you are a life sciences manufacturer, your quality and business objectives have likely changed since the beginning of the year. The emergence of COVID-19 has disrupted the priorities of many medical product manufacturers.

When reviewing this assessment, consider your current level of maturity and whether your capabilities align with where you want to be in your quality management evolution.

Proactive quality is the ultimate goal in life sciences—with the advent of innovations like AI and IoT in the quality management ecosystem, proactive quality is finally becoming a reality.

Discover the fundamentals of ISO 9001 and its relationship to QMS.

Managing and controlling the large number of documents required to be compliant with regulations can be a significant challenge. One solution can be to leverage technology to improve compliance and efficiency.

This episode of Forging Connections, a podcast from Honeywell, welcomes Dr. Oxana K. Pickeral, Ph.D., MBA, President and CEO of Sparta Systems.

Most life sciences manufacturers have plenty of data but lack context. When QMS, MES and BAS operate independently, decisions slow. See how connected digital threads help.

Attend our User Groups to learn how organizations like yours are using the latest Sparta technology to transform their quality and regulatory management organizations.

Are you simply reacting to quality events or are you preventing them from occurring in the first place? Agile and scalable quality management systems (QMS) can help your organization take a proactive approach to quality, giving you the power to ensure patient safety, improve product quality and efficacy, reduce costs and maintain compliance.

Outsourcing is on the rise, with more manufacturers using third parties than ever before. This helps boost the bottom line, but it also introduces certain risks.

Discover how disconnected quality systems create visibility gaps, slow investigations and increase operational risk. Learn how connected quality helps life sciences organizations improve decision-making.

Recent webinar with Dan Jacobs and Stephen McCarthy reveals five common misconceptions about Quality 4.0.

The EU has published its long-anticipated revised GMP Annex 1 for the manufacturing of sterile drug products.

Discover insights from Rahul 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.

With TrackWise Digital, you can access and manage documents from any web-enabled device to improve visibility, collaboration, and efficiency throughout your operation in a controlled digital environment.

Quality management system maturity matters—especially when it comes to your quality processes and systems.

The EU has published its long-anticipated revised GMP Annex 1 for the manufacturing of sterile drug products.

Discover the benefits of TrackWise Digital CAPA management software.

Sparta Quality Best Practices Council is advised by Sparta’s customer base through a monthly Quality Process Council and quarterly Regulatory Council meetings.

Process values, batch execution details and event histories are captured every day. Yet data alone does not drive improvement. The challenge is transforming raw information into actionable knowledge.

Experiences from two TrackWise Digital customers, Arbor Pharmaceuticals and Mikart, Inc., highlight the challenges that companies can face when it comes to document management in the pharmaceutical industry.

In today’s increasingly regulated business environment, the need to investigate and track quality-related events remains a crucial factor in the day-to-day manufacturing operations of organizations.

Hear how Olympus is standardizing, simplifying, and harmonizing to be efficient and compliant globally, with Honeywell Life Sciences.

The GAMP 5 Second Edition was published in July 2022. In this blog post, Sparta’s Industry and Business Development Lead, Max Ma, dives into the key updates of the latest edition.

Suruchi Sharma, Regional Quality Manager at Abbott, shares insightful experience with TrackWise Digital and TrackWise.

Honeywell has introduced a new approach to solving complex industry challenges with the release of the Honeywell Life Sciences Applications Suite, built on the Amazon Web Services (AWS) cloud.

This comprehensive guide provides valuable insights and a checklist-style framework to help you evaluate and select the QMS solution that best aligns with your organization's unique needs and requirements.

Pharmaceutical and biotech manufacturers are operating in increasingly complex environments. Manufacturing Execution Systems (MES) have become essential infrastructure in this context.

Life sciences companies continue to feel growing pressure around the issues of quality and compliance. When attempting to sort through these complexities, it is imperative that organizations leverage an in-depth understanding of the complex regulations that govern quality and compliance and finding a way to ensure that the company’s best practices and record-keeping can stand up to an audit.

Discover insights from Srinivas Hosadurga, Senior Manager-IT at Cipla, as he shares his years long experience on TrackWise, and its vital role in maintaining regulatory compliance.

Learn more about the multiple benefits to a robust RCA process.

In 2024, the trend continued as in previous years, with nearly 2,500 product recalls across the top five industries. The above-average recall rate is expected to persist into 2025, with an increased focus on companies’ ability to implement effective recall management plans.

An essential element of effective quality management is timely access to accurate and complete quality data.

Manufacturers that balance compliance with quality objectives are much more likely to achieve all key objectives at the same time.

QMS Implementation - This article aims to provide valuable insights to individuals seeking to make an informed decision about implementing a QMS by highlighting its key benefits and demonstrating how the overall value outweighs the costs and risks.

Smart manufacturing processes and sophisticated supply chains need to be backed-up by digital document management solutions.

Integrating quality management and document management offers numerous benefits, including improved processes and efficiency, helping to meet compliance with regulations, increased customer satisfaction and enhanced collaboration.

Efficient and effective change management has never been more critical in life sciences, as the global needs for expanded access to medicine and medical products has grows exponentially.

Sparta Systems experts give overviews of industry best practices for managing key quality management processes.

If reducing the risk of recalls is one of your top priorities in 2020, then proactive quality management is a natural fit. Visibility and collaboration are an integral part of a proactive approach, which is challenging when it comes to the supply chain.

Reflecting on World Quality Week 2022 with valuable resources and key insights on quality from customers.

Even small changes in the supply chain can initiate a lengthy set of actions that affect related processes, procedures, and documentation. Otherwise, organizations can’t effectively measure or improve quality across the enterprise.

Measuring the success of a quality management system (QMS) is crucial for demonstrating its effectiveness and ensuring continuous improvement. This article will guide users on how to measure the success of their QMS and provide insights into key performance indicators (KPIs) that can be used to showcase its impact. We will highlight relevant data sources for each KPI to help users source the necessary information.

Speed matters in life sciences manufacturing. At the same time, manufacturers must maintain strict control over quality and compliance.

The ability for the risk management process to create long term quality value for manufacturers is hindered by legacy processes that are a messy result of ad-hoc changes and hasty compliance initiatives.

Explore how companies can leverage automation solutions to transform quality management reviews (QMRs) into a source of valuable insights.

Life sciences manufacturers are facing extraordinary times. Astonishing levels of agility, scalability and flexibility have been required over the past several months. And these demands are likely to continue for the foreseeable future.

In today’s increasingly regulated business environment, the need to investigate and track quality related events remains a crucial factor in the day-to-day manufacturing operations of organizations.

Optimize production with our advanced MES solution for real-time monitoring and seamless system integration with TrackWise.

Industry 4.0 is addressing life sciences workforce shortages, enhancing productivity and integrating smart technologies

Learn how digitalization, MES systems, and unified data can streamline batch records, boost uptime, and improve compliance in biotech & pharma manufacturing.

Reskilling your workforce is not a one-time initiative. It’s a continuing commitment that must be built into the company culture. Learn how you can start today!

Strengthening your OT cybersecurity posture within life sciences includes understanding rising threats, potential vulnerabilities during acquisitions, the complexity of varied systems and the catastrophic consequences of breaches.

Companies are adjusting not just to a shortage, but to a workforce transformation already in motion. Here are five ways technology is changing the way work gets done in life sciences manufacturing.

Learn how disconnected manufacturing, quality and facility systems increase quality costs, delay batch release and create compliance risk in life sciences.