FEATURED ARTICLES

• How To Avoid Pharma’s Top 5 FDA Form 483 Triggers

  Read about most commonly cited conditions that led to the issuance of Form 483s to drug companies last year (as summarized by the FDA in the most recent 12-month inspection period on record) and practical tips for avoiding them.

• Ensuring Drug Accountability In Clinical Trials

  Pharmaceutical companies, and regulators, can’t be assured the results of the trial are accurate if there’s information missing from the drug accountability record. Ensuring proper drug accountability is far from simple. It requires forethought and consistency to be done properly.

• Writing and Enforcing GxP SOPs For Compliance

  For fiscal year 2020, the most common FDA inspectional observations for biologics, devices, and drugs involved SOPs. To avoid a warning letter from the FDA, life sciences companies need a methodical approach to their SOPs.

• Why Automation Is Essential For Document Control Compliance

  In medical device development, speed, efficiency, and accuracy with document control processes are a top priority.  Regulators are embracing advancing technologies to effectively achieve their mission of ensuring public health and safety — including enhancements directly related to documentation.

• Identifying And Preventing Common Data Integrity Issues

  Data integrity plays a key role in all areas of CGMP compliance, and the FDA expects all data to be reliable and accurate.  A good approach to achieving and maintaining data integrity compliance is to develop a practical data management strategy that involves employees, IT data management processes, and company policies.

• Supplier Quality Agreements 101: What, Who, And Why?

  Medical device and pharmaceutical manufacturers are ultimately responsible for the products they make and sell, even if they outsource some or all of their manufacturing or other operations. To ensure that products are safe and meet the claims made for them, the FDA and other regulatory bodies are looking to the companies that sell the product to have sufficient control over their suppliers. Quality agreements with suppliers can go a long way to demonstrating the kinds of control that medical device manufacturers have over their suppliers.

• Quality System Metrics That Matter

  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.

• What's The Difference When It Comes To Managing Quality?

  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.

• Annex 11: The EU’s New Expectations For Regulated Computerized Systems

  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.

• 21 CFR Part 11 — Are You Ready For An FDA Inspection?

  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.

• 21 CFR Part 11: Risks Of Noncompliance

  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.

• Adapting To Pharma’s Next Normal

  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.

• Getting Executive Backing For A Digital QMS

  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.

• The Business Case For Life Sciences Moving To The Cloud

  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.

• 6 Must-Haves For A Quality Management System (QMS)

  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.

• Top Five Ways Digitization Of Paper-Based Processes Can Boost Financial Success

  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.

• Automating Document Control Processes To Comply With FDA And ISO Requirements

  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.

• Overcoming Pharma’s Top 6 Quality And Compliance Oversights

  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.

• Meeting Quality Standards With Multiple Global Manufacturing Locations

  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.

• How Digitization Enables Safe, Connected Operations In Manufacturing

  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.