CAPA Solutions for Manufacturing: How to Resolve Backlogged CAPAs in ISO 13485 Regulated Environments

It’s not uncommon for medical device organizations to have bottlenecks with corrective actions/preventative actions (CAPAs). In this blog post, QA Connect CEO Leah Jones shares tips on streamlining CAPA management processes and improving root cause investigations.

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EU to U.S. Market, Part 2: Strategic Audits for Expansion Into U.S. Medical Device Market

Part 2 in Cannon Quality Group’s blog series focuses on three ways manufacturers can leverage audits to streamline entry into the U.S. medical device market, avoid costly mistakes, and take advantage of this underused tool to ensure FDA compliance.

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A Blueprint for Navigating the Medical Device Regulatory Compliance Landscape

The medical device industry serves a crucial role in improving patient lives, but navigating the complexities of regulatory compliance can be daunting. Discover resources that will give your quality and manufacturing teams the critical knowledge and practical strategies they need to tackle compliance challenges.

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Harnessing DevOps for GxP Compliance: Streamlining Life Sciences Software Development

GxP compliance in software development processes improves data safeguarding and promotes trust. In this post, SPK and Associates Vice President Michael Roberts examines how DevOps in life sciences manufacturing facilitates GxP compliance, innovation acceleration, and superior software quality.

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Accelerating Batch Record Reviews With Electronic Batch Records

Electronic batch records (EBRs) can save you tons of time and eliminate frustration in reviews. Learn how you can reclaim time so you can focus on truly resolving quality issues instead of chasing paper.

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Harnessing the Power of Electronic Batch Records: bioMérieux’s EBR Journey

Paper batch records are a threat to data integrity and efficiency in life sciences manufacturing. If you're considering making the change to electronic batch records, bioMérieux's experience offers valuable insight into the selection process, implementation strategies, and the long-term benefits of modern EBR software.

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The Costly Impact of Nonconformance on Your Business

Finding out the costs of nonconformance can help you improve, prevent future problems, and save money. In this blog post, Medpoint CEO Dr. David Orr examines different ways to measure nonconformance costs, including using nonconformance management software and having a good quality management system (QMS).

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A Pharma Roadmap to Simplified FDA and ISO Compliance Management

Are you overwhelmed by all the FDA and ISO regulatory requirements pharma companies must meet? If your organization faces the common types of FDA and ISO compliance management challenges covered in this blog, it’s time to implement a pharmaceutical compliance software solution that can help you overcome them.

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Mastering Document Control Chaos With Efficient Processes and Change Management Strategies

As manufacturing operations evolve, there’s an increasing need for more efficient document management. Enterey’s Ryan Coughlin examines how life sciences manufacturers can turn document chaos into document control.

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What Medical Device Manufacturers Stand to Gain From Part 820/ISO 13485 Harmonization

Now that the QMSR makes 21 CFR Part 820/ISO 13485 harmonization official, medical device manufacturers stand to benefit in a variety of ways. This blog post examines the significance of the harmonization to industry stakeholders.

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EU to U.S. Market: Understanding 3 Core Regulatory Contrasts

Both the EU and U.S. markets are highly regulated, but there are important differences in medical device compliance that must be considered before taking the plunge. Cannon Quality Group examines three core regulatory contrasts that can make the difference in the success of your market entry.

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Digital Logbooks: A Game-Changer for Nutrawise Health & Beauty

As one of the largest manufacturers of collagen and turmeric in the U.S., Nutrawise Health & Beauty has dealt with numerous challenges involving paper logbooks. This post highlights the burdens the company has overcome by adopting logbook software.

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A Complete 21 CFR Part 11 Compliance Checklist for Quality Managers

Compliance with 21 CFR Part 11 is a big deal for life sciences companies. Failure to meet Part 11 requirements can result in serious consequences like product recalls and legal actions. Make sure all your regulatory bases are covered with this 21 CFR Part 11 compliance checklist.

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Top 10 Quality Event Management Goals for the New Year

Reduce the number of quality events and errors with these top 10 goals for the New Year. Learn about advanced quality event management (QEM) solutions to help you achieve continuous improvement for years to come.

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Best of 2023: Last Year’s Most-Viewed Resources and Blog Posts

Wondering which manufacturing and quality topics your colleagues, competitors, and industry peers are most interested in? Check out this list of the top blog posts, reports, guides, industry briefs, and webinars viewed last year.

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Behind the Bouts: Championing AI in the Pharma Manufacturing Arena

The predictive analytics and quality control capabilities artificial intelligence provides help not only to anticipate disruptions but also to ensure products meet stringent quality standards. In this post, FojiSoft CEO Mitchell Hirsche highlights how AI facilitates pharmaceutical customization, improves supply chain logistics, and brings significant cost and environmental benefits.

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AI Gets Real: Practical AI Solutions for Pharma

With all the recent chatter, you may be wondering what generative AI means for pharma quality and manufacturing. This blog explores the differences between traditional and generative AI, points out some practical ways AI can enhance business processes, and how EU legislators are getting into “the AI Act.”

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Medical Device Industry Trends: Internet of Medical Things

Internet of Medical Things (IoMT) technologies let physicians monitor patients remotely and collect more medical data faster than would be possible in any other way. However, just as with other connected devices, those in the medical sector need to be carefully controlled to ensure they remain secure.

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How Effective Product Supply Management Benefits Emerging Life Sciences Companies

Product supply management is often taken for granted in the life sciences. Find out why investing in product supply management improvements is in the best interest of all life sciences organizations, particularly emerging companies.

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Simplifying Complexity in Business Operations Through Continuous Process Improvement

In the ever-changing business landscape, effective change management is crucial for organizational success. Companies must implement a well-thought-out process that not only anticipates inevitable changes but also addresses them in a positive and proactive manner. Enterey’s Ryan Coughlin offers tips on continuous process improvement.

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