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.

This guide will help you understand the fundamental components of a Quality Management System (QMS) software and how QMS solutions are evolving to keep pace with business dynamics.

How adopting a data-driven and technology-supported approach to quality and product life cycle management can enable pharma and biotech organizations to not just survive, but thrive.

The digital documentation layer of quality and compliance processes is still critical and will never go away, but advanced technologies are helping life sciences organizations unlock the data side of the equation.

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

What requirements should CGT 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.