Gain an understanding of how leading pharmaceutical manufacturers are modernizing their operations, how to stay current with industry trends, and ensure long-term relevance in the value chain.

With so many manufacturing software products on the market today, evaluating and choosing the right one for your organization can be overwhelming. It doesn't have to be if you know the essential capabilities you need.

Explore the state of digital transformation in manufacturing and learn how you can extend your digital edge.

Explore three practical steps pharma manufacturers can take today to start modernizing and streamlining their pharma supply management activities and to keep up with new approaches to supplier management.

Adaptability is the new superpower in pharma manufacturing. By staying on top of these trends, manufacturers will be better positioned for success in the competitive, rapidly evolving pharma industry.

The world has changed dramatically in recent years, exposing vulnerabilities in supply chains, quality assurance, and other concerns. Explore how quality leaders are tackling pharma disruptions and more.

The objective of QMM is to elevate quality beyond the base level of cGMP. Explore practical paths to pharma QMM and the key benefits of a digital pharma QMS.

To stay competitive in an increasingly dynamic field, pharma and biotech manufacturers are implementing numerous beneficial technologies to automate and streamline production. Explore the power of MES integration.

Explore the elements critical to 21 CFR Part 11 compliance, how they relate to noncompliance risks, and how a QMS software solution for life sciences simplifies the compliance process.

MasterControl, a leading provider of quality and manufacturing software solutions for the life sciences, announced its first ever funding, a $150 million Series A round led by Sixth Street Growth. MasterControl has grown profitably for nearly 30 years, and with this funding is valued at $1.3 billion. The proceeds will be used to accelerate the development of SaaS solutions serving the company’s global life sciences customers, which include Pfizer, Cochlear, Thermo Fisher Scientific and more than 1,100 others worldwide.

Quality 4.0 transformation has gained momentum over the last few years, and most companies are not seeing their expected results. Learn about an opportunity to change this ongoing pattern.

With many options for digital transformation in the quality software sector, there’s never been more opportunity to digitize your QMS. Explore the benefits of a digital QMS and more.

Even a small amount of paper on the factory floor carries hidden costs in impeded throughput, productivity, and on-time shipment. Explore the benefits of a modern MES software solution.

The COVID-19 pandemic has changed audits and inspections. To combat these challenges, companies need to adopt an electronic quality management system that covers every aspect of audits and inspections.

Learn how having a 6S program tethered to a hierarchy of needs will provide safety for your team when introducing new lean manufacturing processes or continuous improvement software.

In medical technology manufacturing, organizations must maintain complete and accurate device history records (DHRs). For those manufacturers regulated by the U.S. Food and Drug Administration (FDA), the agency has made it clear. If the DHR doesn’t include complete information relating to the production and control of each lot or batch, the medtech manufacturer risks product quality issues or worse. Between 2017-2021, DHRs were among the top medical device warning letters issued by the FDA.

For companies developing regulated products, explore why everything that happens to equipment must be appropriately documented to maintain compliance with current good manufacturing practices (cGMP).

Data integrity is established where the data is stored and managed in its original form. Discover why the FDA expects manufacturers to ensure all data meets the guidelines outlined in the ALCOA acronym.

Explore the urgent need for businesses to adopt strong data integrity practices and identifies measures for how to achieve and sustain compliance.

A CAPA management system can provide your company with the ability to recognize and correct risks. Learn how to ensure your CAPA management system benefits the manufacturing process.

Learn how to embed risk-based thinking into quality efforts with an integrated risk management software. 

Six steps to reducing the time, pain, and expense of the software validation process while maintaining quality and safety.

Learn how to improve traditional risk management methods and tools and how AI can help in the identification and mitigation of risk.

Learn how a modern Manufacturing Execution System (MES) is using digital production records to help manufacturers regulated by the FDA improve their quality and efficiency goals.

What requirements should cell and gene therapy developers meet to successfully bring innovative therapies to market?

Learn how digital solutions and a modern ERP system can effectively combat counterfeit med devices and pharmaceuticals to improve patient safety and business performance.

QSR compliance can be complex, but it doesn’t have to be burdensome. Implementing these best practices will improve your regulatory compliance while producing a product ready for market.

As a pharmaceutical product manufacturer, you regularly deal with a lot of processes, phases, and moving parts along the supply chain to get your products to market. The pharmaceutical industry is complex and highly competitive. It has become essential to seek out ways to scale, improve processes, minimize errors, reduce lead times, and keep quality and compliance at the top of the priority list.

We share how to get the most out of documenting your quality management system that can also help you stick to ISO 9001 standards.

While all enterprise software implementations are unique we share six best practices that will improve the likelihood of any successful quality management software implementation project.

In this blog we highlight the history and purpose of a document management system and look into the future with cloud-based electronic document software.

Review three biopharma contract manufacturing trends that are indicators of exciting industry developments and also reveal areas that are ripe for change.

For manufacturing organizations that haven’t fully digitized their production processes because of the high cost and complexity of conventional MES solutions, it’s time to put those fears to rest. This industry brief explores and dispels six common misconceptions of adopting MES in life sciences manufacturing.

We share some SOP guidelines that can help you build and manage documents that are easily accessible, relevant, and something your team can consistently rely upon.

While CSV can be a pain to deal with, it is necessary. Explore our eight best practices that can reduce validation time to a matter of hours or minutes.

Explore the relationship between FDA predicate rules and GMP, GLP, GCP, or other requirements applicable to your organization. 

Learn how to significantly lighten the software validation load for your cloud environment system with these eight key practices. 

Explore the FDA's e-transformation that promises to usher in a new era of electronic interactions between the agency and its constituents.

Learn why time is of the essence when crafting a FDA response letter and remediation plan as well as the best practices for responding.

Explore how embracing digitization in manufacturing can help CMOs and CDMOs improve the efficiency of their operation and attract company partnerships. 

This brief provides an understanding of the roles corrective actions/preventive actions (CAPAs) serve in regulatory compliance and product quality improvement, offering a blueprint to help optimized strategies.

With issues involving quality responsibilities and procedures at the top of the FDA warning list, we uncover where the solution to make this problem a thing of the past.

We outline the steps to take before, during and after an FDA inspection so the FDA’s call to schedule an inspection doesn’t have to be a nightmare scenario.

Despite the inherent challenges of connecting quality and compliance data, there are tools that can help you to ensure quality's connectedness and central bearing. 

Learn practical steps that help pharma contract outsourcers exercise greater control over their supplier-related data, interactions, and processes and put them in a better position to cope with supply continuity challenges as they arise.

Learn how to gain a lead position in the market by digitally connecting and unifying all areas of your enterprise.

Suppliers and manufacturers working together to improve quality throughout the supply chain creates high quality standards to ensure final products are safe and effective.

We review commonly perceived barriers to adopting a traditional MES solution and how the path to digitization in manufacturing is easier than manufacturers might think.

If your company isn’t at least planning on implementing an EQMS solution or other advanced digital tools, learn why now is the time to start.

We answer questions regarding the FDA's indication that a risk-based approach is compliant and significantly reduces the burden on life sciences companies.

Learn where modern manufacturing execution software can, and should, provide the essential functionality needed to address pharmaceutical and medical device manufacturers’ pressing production needs.

Product shortages — particularly pharmaceuticals — have imposed the heaviest toll on society. We outline recommendations for improving your pharma supply chain operations.