FEATURED ARTICLES

• ISO Standards: Turning Hopes Into True Quality Objectives

  Aligning your company’s quality management practices with the applicable quality principles found in the ISO 9000 family of standards is a proven approach for turning aspirations into actual quality objectives. Here, we review key quality principles addressed in ISO 9001 and examples of ways the standard can be leveraged to reach the kinds of objectives your organization may be looking to achieve.

• FDA Inspection Preparation: SOPs, Process Maps, And Gap Analysis

  Process mapping and gap analysis can help manufacturers not only show the FDA that an organization is compliant with regulatory expectations, but also help demonstrate that standard operating procedures (SOPs) are correct and that employees understand them.

• Simplifying Commercial Software Validation In Medtech Manufacturing

  Commercial off-the-shelf (COTS) software has dramatically enhanced medical device manufacturers’ ability to accelerate production, integrate processes, and manage quality effectively. Learn more about FDA guidelines on the horizon for COTS software and tips on how to approach validation until such guidelines are finalized.

• How Electronic Batch Records And Device History Records Close The Digital Manufacturing Gap

  We need to remedy the fact that the vast majority of life science manufacturers are still on paper. Digitizing the paper-based production record process can close this gap by creating productive connections between people, processes, and systems throughout the manufacturing process and across the entire enterprise for a holistic view of production data.

• MasterControl Announces Annual Recurring Revenue Milestone

  MasterControl, a global provider of software solutions for life sciences and other regulated industries, today announced it has reached $100 million in annual recurring revenue (ARR), led by their signature software solutions, Quality Excellence and Manufacturing Excellence, as well as the recent launch of MasterControl Insights.

• A Risk-Based Approach To Supplier And Vendor Audits

  With the right tools, supplier and vendor audits can be an effective mechanism for gaining that visibility and improving product quality. Digital supplier quality management tools can dramatically enhance supplier audits and vendor qualification audits in a number of ways.

• 5 Ways Digital Technology Will Transform The Supply Chain

  When data is digitized and connected to other data points across the enterprise by the IoT, and analyzed by AI algorithms, the data becomes more visible, usable, and valuable. Several technologies have emerged to help life sciences companies excel in an increasingly digital economy. Here is what five of these technologies mean for the life sciences supply chain.

• Developing An Effective Supplier Scorecard

  The supplier scorecard is an effective form of communication because it sets up a structured measurement of collaboration where the supplier always knows their score and how they’re trending. In this blog we outline five things to consider when creating a supplied scorecard.

• The Role Of Supply Agreements In Life Sciences Manufacturing

  In light of the disruption and the urgency around fast delivery of high-quality products, it makes sense that manufacturers and their suppliers might reassess their relationships and obligations to one another to manage the results of disruption to supply chain partners. Working with your supply partners to achieve their obligations starts with understanding your company’s existing supply agreements.

• 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.

• Vital Signs Of The Medical Device Industry

  The medical device industry emerged from 2020 a little beat up and bruised, but those that were able to adapt successfully will act as models for 2021 and beyond. As the medtech ecosystem and medical device regulations continue to evolve in conjunction with the continued pressure to meet demand while adhering to quality expectations, medical device companies must embrace digital transformation and shifts in mindset to remain competitive.

• 5 Medical Device Best Practices For Managing Risk To Users, Patients, And The Environment

  Medical device companies of all sizes are often concerned about speed-to-market, new device clearance overhead costs to maintain compliance, and lack of certainty about what is needed to maintain compliance, and fear of non-compliance consequences. We explain how to meet these compliance standards by following these best practices to bring new medical devices to market with success.

• Cybersecurity In Medical Device Development

  Security now needs a seat at the medical device design table, accompanied by its own list of requirements. Here are resources to identify specific areas to focus cybersecurity efforts throughout the product’s life cycle.

• 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.

• Compliance Tips For New Medical Device Products

  How can you guarantee that your medical device will not only perform as designed, but also conform to the highest regulatory standards? By designing for compliance you can meet this goal.

• 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.

• Digitization In Medical Device Manufacturing: 4 Priorities

  Over the past year and a half, the global business disruption has created a sense of urgency around accelerating efforts to digitize and connect offline or siloed areas of operations. Most manufacturers see the benefits of digital transformation, but many don’t see the roadmap. Here are a few ways to apply digitization to enable agility and improve operations.

• 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.

• How A Platform Approach To Technology Modernization Is Transforming Manufacturing Performance And Quality

  A provider of digital X-ray products and X-ray films with more than 4,400 employees in globally distributed locations was focused on updating their legacy systems. Read how a flexible solution has allowed them to deploy fewer, more modern technology tools across their global manufacturing environment with a single platform for production and quality management, which has resulted in improved visibility, efficiency, productivity and risk mitigation.