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.

The Precision Medicine Initiative is driving forward the potential for a more customized health care approach, transforming the way health care professionals are treating diseases.

It has become clear that digitizing production processes is no longer optional for CMOs and CDMO's, but a necessity to keep up with the demand and competition in the pharmaceutical, biotechnology, and medical technology industries.

Solve your companies manual manufacturing production records problems with modern manufacturing execution systems and gain the competitive advantage.

Explore the primary responsibilities of both manufacturers and vendors during a vendor compliance audit, as well as practical strategies and tools, including audit management software, that make them possible.

Pharmaceutical manufacturers are exploring comprehensive computer software assurance (CSA) approaches, the benefits of implementing a risk-based framework, when to apply it, and the first steps to this CSA approach.

Learn how regulated product manufacturers are meeting the demand for faster development and delivery of products to patients and where your operations fit in the digital maturity manufacturing model.

Reduce your pre-audit stress and pave the way to successfully meeting ISO 9001 standards and becoming certified.

To help companies achieve Pharma 4.0, the International Society for Pharmaceutical Engineering is driving Validation 4.0 as a way to help organizations expedite the computer software validation process.

Learn about the benefits of patient centricity and an enterprise-wide approach to products, processes, and partnership that focuses on the patient perspective.

We accept the aid of automated paperless technology in our everyday lives, so why not in life sciences manufacturing? Check out some of the benefits of eLogbook management.

Explore four reasons why your medtech startups is ready to implement quality management system and move into a new digital age.

Take an in-depth look at the pitfalls of manual, paper-based manufacturing processes and why digitization could be the answer for pharma and medtech manufacturing of the future.

Explore four legitimate reasons to conduct a supplier audit and five steps to achieve a better supplier quality audit.

How can you utilize your production data to its fullest? Explore the use of data lakes to store enormous amounts of structured, semi-structured, and unstructured data.

Discover advanced software solutions that offer connected and coordinated processes with real-time insights and predictive analytics to help you keep pace with the trends in quality management.

Learn how to optimize pharma quality management data and design, themes to keep in mind when implementing AI, and ways to lay the foundation for AI solutions.

Explore the eight key benefits of EBR Software and what makes this digital manufacturing solution superior to the traditional paper-based approach to managing critical documentation.

See poll results illustrating how quality experts in Life Science industries prioritize digitalization, compared to steps actually being taken to the future at this time.

Ease the stress of a U.S. Food and Drug Administration (FDA) visit to your facility by learning how to maintain a state of FDA audit process readiness.

Explore how paper batch records hold back cell and gene therapy manufacturing and the digital solutions that could help improve efficiency.

How can your company capitalize on the latest quality management trends by adding Total Quality Management tools to their toolboxes?

Change control is integral to continuous quality improvement and customer satisfaction. Learn about the manufacturing change control process, its requirements, and the characteristics a change control system should possess.

Learn how going paperless on the production floor can produce measurable results that have a significant impact on manufacturing operations, product quality, and the bottom line.

Since the COVID-19 pandemic first hit, remote audits and inspections have been essential. Learn about remote audits and inspections and how audit management software can make the process easier.

With the constant introduction of new technologies, employees are regularly overwhelmed by organizational complexity and information overload. Learn how to achieve simplicity in quality management, facilitate change, and more.

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.

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