ABOUT MASTERCONTROL

The Fastest Path to Paperless, Errorless and Frictionless Production.

Because the costs of drug development continue to climb, you have to work fast. The pressure is on to develop safe, effective drugs quickly. Mistakes cause delays. With each delay, you’re less likely to recover costs and make a profit.

MasterControl delivers the next level of manufacturing excellence by bridging the gap between performance and quality with digital production records that finally let you go 100% paperless.

Manufacturing Execution Simplified

Make Paperless a Reality. As manufacturing environments become more digitized and automated, you can’t afford the production delays, documentation errors and duplicated efforts that persist with paper-based or hybrid production records.

Gain a Performance Edge. It’s no secret that getting high-quality products to market quickly and cost effectively is a recipe for success. MasterControl’s truly paperless manufacturing solutions bridge the digital divide between human personnel and industrial automation, helping your production teams improve the metrics that matter – from lower scrap rates and shorter lead times to increased fill rates and improved yields.

Connect with Quality.  With an integrated digital manufacturing system that crosses the traditional barriers between quality and manufacturing, you can predict and detect quality trends sooner and pinpoint their causes, whether human, machine or environmental. Fully digital batch, device history, calibration and maintenance records connect with your quality systems to automatically flag issues and initiate corrective actions.

FEATURED PRODUCTS

The out-of-specification (OOS) product in the MasterControl Quality Management System (QMS) allows for seamless compliance.

Simplify clinical management with a single platform. MasterControl allows you to connect all clinical data, documents, tasks and processes.

Automate batch processes. Improve efficiency. Ease growing pains. A proven recipe management software system can help you do it all.

MasterControl software automates equipment calibration processes. It helps manufacturers improve their performance and ensure audit-readiness.

Streamlined investigation and resolution of product deviations. Improved quality. Simplified compliance. MasterControl deviation management software can help you make it happen.

Quality events are inevitable, no matter how much care is taken to avoid them. As a critical part of a quality management system, CAPA identifies and addresses the root causes of high-risk quality issues and helps to limit the resulting business impact, both immediately and in the future.

Quality can never be a differentiator if it's an afterthought or a box to be checked. A complete, end-to-end digital quality management system makes quality at the source possible – and compliance issues a thing of the past.

CONTACT INFORMATION

MasterControl, Inc.

6350 South 3000 East

Salt Lake City, UT 84121

UNITED STATES

Phone: Sales 1.888.873.5164

FEATURED ARTICLES

  • Despite the robust enterprise software solutions on the market, many manufacturers still struggle to fully digitize and thus, fully connect their operations. In particular, production records and other processes on the edges of the operation continue to rely on paper-based systems. This white paper explores the risks and missed opportunities that result from using paper and other standalone tools, and discusses how a new intelligent-edge solution can provide an operational advantage by collecting, connecting and contextualizing production record data.

  • Companies engaged in clinical manufacturing must continually make rapid yet precise adjustments. To pivot quickly, companies need the right proficiencies and tools. Learn the keys to adapting operations to suit a more targeted approach to development.

  • Many life sciences companies have implemented manufacturing information systems as part of their automated manufacturing initiatives aimed at increasing product quality and lowering manufacturing costs however, paper production records and a hyper-focus on compliance remain a reality for many emerging and mid-market companies. This paper explores how companies that shift from paper to data-driven intelligence are able to better leverage manufacturing data to improve the reliability of their quality metrics and support their regulatory compliance and business improvement efforts.

  • Metrics reign supreme in manufacturing, which means any new technology must be evaluated on its ability to drive measurable, scalable impact to your production operations, product quality and site performance. Read how companies that have implemented a digital solution for their batch records, design history records (DHRs), travelers and routers have seen immediate impacts in key performance areas.

  • Precision medicine, or personalized medicine, offers unprecedented opportunities for life sciences companies and patients alike. This article highlights how embracing digital technologies, data management and supply chain tools, and leaning into regulatory change, can help companies adapt their business to changes in personalized medicine and reap the benefits.

  • Despite the many advantages of digitizing, automating and integrating manufacturing management systems, the truly paperless factory floor remains an elusive goal for most companies. This paper provides a summary and comparison of the leading manufacturing software solutions available today, discusses selection considerations given their strengths and shortcomings, and presents a vision of what manufacturers need to achieve a truly paperless production floor in their pursuit of manufacturing excellence.

  • Product quality is a top priority in any business because nothing else matters without it. Measuring the impact of quality instantly becomes the No. 1 business imperative when those process inefficiencies begin to negatively affect the bottom line. See how these companies digitized and connected their document management processes to help accelerate the time it takes to get a product to market without jeopardizing regulatory compliance.

  • QA and QC are not identical or interchangeable, but you’re likely to have peers who don’t understand the distinctions between them. Read this blog to help such individuals solve the mystery behind these frequently conflated quality functions.

  • The Annex 11 Guidance is for the lifecycle of computerized systems to reflect the increased use and complexity of automated systems in the pharmaceutical industry. In this paper we cover the Scope of Annex 11, it's impact on medical device companies and its role in inspection readiness.

  • Part 11 has been scrutinized and criticized over the years, but it remains in effect today. Given the pervasive automation of processes and digitization of data today, the regulation is more relevant than ever. In this paper we break down what Part 11 means and how to get inspection ready.

  • Throughout a recent FDA Guidance for Industry: Part 11, the message is clear: compliance to the underlying predicate rules remains critical; the FDA will enforce predicate requirements for records subject to Part 11. In this article we further explain the guidance, review warning letters, and offer a solution to meet FDA and ISO regulations.

  • To survive in a competitive and unrelenting industry, pharmaceutical and biotech companies must continually focus on improvement. But when the pace and magnitude of change renders traditional improvement approaches ineffective, companies must evolve to survive. That’s the crisis facing all organizations throughout the global pharma industry, and those who implement new operational models and technologies sooner will be far better positioned for adaptability and success.

  • As someone working in quality, you understand how vital your role is for improving efficiency, achieving quality, and meeting compliance. Your work is critical, and it’s essential to have the right tools do your job well – which means having a digital quality management system (QMS). Most executives cite the high cost of adopting technology as the main reason they reject plans to invest in digital systems. This article offers guidance that will help you quantify and communicate the importance of quality, and how a digital QMS delivers considerable savings.

  • What does it mean to move to the cloud for your organization? What benefits can be realized and what questions should you ask as you evaluate the right cloud partner. By citing research and use cases, this paper will explore the benefits of cloud services, along with some of the challenges associated with migration, as you weigh what makes sense for your organization.

  • The best way to build quality into a product is with an effective, connected quality management system (QMS), which serves as the foundation for long-term regulatory compliance and market success. However, not every QMS has the same capabilities and connectivity. A QMS that isn’t connected to other areas of the enterprise still slows down quality processes and introduces the possibility of more human error. In this article we highlight six features of a QMS system that will help companies realize maximum value for years to come.

  • More companies are beginning to understand the benefits of technology, and, 80% of companies now indicate that accelerating their digital transformation is a strategic necessity. This article will focus on how technology – specifically the digitization of paper-based processes – can help life sciences companies and other regulated industries attain two of the most pressing business goals across the board: lowering costs and realizing profits sooner.

  • Careful handling of the large amounts of documentation required for regulated products is critical for achieving compliance. Furthermore, document control guidelines enforced by the U.S. Food and Drug Administration (FDA) and the standards set by the International Organization for Standardization (ISO) continue to evolve. This means your document control system should be agile and scalable to keep up with the changing regulatory landscape. This article details the FDA guidelines and ISO standards that apply to document control, and it illustrates how digitizing document control processes is essential for ensuring ongoing compliance and future relevance.

  • For companies doing business in the heavily regulated pharmaceutical industry, quality management and compliance are not just intimidating endeavors — they involve activities that are increasing in complexity as the industry accelerates. This article presents six common quality and compliance missteps that pharma companies either inadvertently enable or unknowingly perpetuate over time. It also recommends actions organizations can take today to help mitigate the long- and short-term problems caused by each oversight.

  • With 66 global locations from Kansas to Krakow, Fagron needed a way to ensure each facility could stay in compliance with the regulations of every market they serve. The variety of processing by regulating authorities based on the country led to inconsistent processes. By implementing a software solution the team has reduced over 450 hours per year spent on preparing paper-based training materials, saving more than 500 sheets of paper per week at those sites.

  • The global business disruption caused by COVID-19 has exposed weaknesses in manufacturing. In this article, we discuss some production challenges revealed by COVID-19, and reasons to digitize.