• 2021-bl-executive-backing-digital-qms_132x132

    Tips to Gain Executive Support for a Digital QMS

    Persuade executives to support your efforts to adopt a digital quality management system (QMS) by speaking to their pain points around costs.

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  • 483s

    How to Avoid Pharma’s Top 5 FDA Form 483 Triggers

    Form 483 inspectional observation reports from the FDA result in painful and costly nightmares for pharmaceutical companies. Learn the top five reasons the agency issues Form 483s and find out best practices for steering clear of them.

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  • 2021-bl-iso-9001_132x132

    5 Tips for a Successful ISO 9001:2015 Certification Audit

    ISO 9001 defines the criteria for quality management systems (QMS), which mostly applies to companies involved with regulated products or services. This post provides useful tips for successfully preparing for and completing an ISO 9001:2015 audit.

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  • 2021-bl-systems-used-clinical-trials_132x132

    5 Things to Know When Using Computerized Systems in Clinical Trials

    Innovative streamlining technologies like the cloud are transforming the way clinical trials are conducted and monitored. If you want to stay in the FDA’s good graces, there are five key elements you need to understand when using digital tools in your clinical activities.

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  • 2021-bl-prevent-data-integrity-issues_132x132

    Identifying and Preventing Common Data Integrity Issues

    Current good manufacturing practices (CGMPs) are minimum requirements that companies must meet in developing health care-related products. Data integrity plays a key role in all areas of GMP compliance. This post provides tips on developing a data management strategy to ensure ongoing compliance with data integrity guidelines.

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  • 2021-bl-design-for-compliance_132x132

    How to Design for Compliance: Tips for Getting (and Keeping) Your New Product on the Market

    The FDA continues to endeavor to reduce the regulatory burden on medical device manufacturers. Still, devices need to make the trek through the regulatory pathway to achieve market approval. This post details how medtech companies can achieve successful product compliance and a faster market launch.

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  • 2021-bl-automating-document-control2_132x132

    Why Automation Is Essential for Document Control Compliance

    Global regulatory agencies continue to evolve their processes and technologies to help companies achieve compliance with this critical aspect of quality management. This post explores document control automation practices as well as the efforts of global regulatory agencies to encourage modernization among life sciences companies.

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  • 2021-bl-enterey-change-management_132x132

    Change Management: Enabling Successful Adoption

    In the life sciences digitization is a powerful way to improve efficiency, but the successful adoption of new digital tools requires effective change management.

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  • 2021-bl-writing-enforcing-sop_132x132

    Writing and Enforcing GxP SOPs for Compliance

    A look at the data collected by the U.S. Food and Drug Administration (FDA) makes it clear that in life sciences, standard operating procedures (SOPs) tend to be a compliance problem. Digital tools and good practices for writing and enforcing SOPs are key to making them effective and compliant.

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  • 2021-bl-cyber-security-risk-management_132x132

    Cybersecurity in Medical Device Development

    The vast interconnectivity of medical devices is widening the attack surface of the public health sector. Intrusions and breaches are possible because of weaknesses in a medical device’s cybersecurity design. This post discusses the security vulnerabilities in medical devices and provides tips and resources for companies to strengthen their cybersecurity posture.

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  • 2021-bl-med-device-managing-risk_132x132

    5 Medical Device Best Practices for Managing Risk to Users, Patients, and the Environment

    Medical device companies can take a risk-based approach, which simplifies regulatory compliance while alleviating concerns about speed-to-market and new device clearance overhead costs to maintain compliance.

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  • 2021-bl-supplier-quality-agreements_132x132

    Supplier Quality Agreements 101: What, Who, and Why?

    Medical device 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, regulatory bodies are looking to the companies that sell the product to have sufficient control over their suppliers. Quality agreements can go a long way to demonstrating the kinds of control that manufacturers have over their suppliers.

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  • 2021-bl-drug-accountability-clinical-trials_132x132

    Ensuring Drug Accountability in Clinical Trials

    Drug accountability in clinical trials holds the organizations and people involved accountable for how they handle the drug being used. Accurate records are essential for compliant and reliable results.

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  • 2021-bl-standards-harmonization-and-eu-mdr_132x132

    The Standards Harmonization Process and 5 Tips to Manage It With EU MDR

    With the roll out of the EU’s Medical Device Regulation (MDR) and In Vitro Device Regulation (IVDR), an increasing number of harmonized standards are out of date. This post addresses the current status of harmonized standards under MDR/IVDR and provides tips for dealing with the challenges of meeting compliance with the new regulations.

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  • 2021-bl-eifu-impact-on-qms_132x132

    The Impact of Implementing an eIFU Solution on Your Quality Management System

    Electronic instructions for use (eIFU) are just as compliant as paper ones, but any implementation of a new system is going to affect existing ones. In particular, the quality management system (QMS) will need to be updated in certain areas to prepare for the switch.

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  • 2021-bl-med-device-trends_132x132

    Digitization in Medical Device Manufacturing: 4 Priorities

    Though most manufacturers may recognize the benefits of digital transformation, many don’t see the roadmap. But there is a realistic path forward that helps mitigate or minimize many real barriers. The key is to make small changes in areas where you will see the biggest impact.

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  • 2021-bl-capa-documentation_132x132

    Five Steps to Simplifying CAPA Documentation Processes

    CAPA documentation failures are the most common citation in Form 483s that the FDA issues to medical device manufacturers. Learn five prudent measures you can take to ensure your CAPA documentation meets regulators’ expectations.

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  • 2021-bl-fagron-new-expanded-case-study_132x132

    Fagron’s Key to Quality Alignment: Extending QMS Capabilities

    Global pharmaceutical compounder Fagron is closing in on its goal to align quality across 66 sites worldwide. Discover how expanding the use of its cloud-based quality management system (QMS) to more business units is turning the company’s quality dreams into reality.

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  • 2021-bl-metrics-collection_132x132

    5 Steps to Metrics Collection and Usage

    Gut instinct doesn’t cut it when making business decisions — especially in businesses that revolve around compliance and consumer safety. Hence the emphasis on big data and making data-driven decisions. It’s easy to say you want to use data, but to use it effectively you first need to take a step back and look at the bigger picture.

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  • 2021-bl-enterey-implementation-integration_132x132

    Process Implementation and Integration

    When approaching the implementation and integration of a new system, you need a method to assess and distill a complex problem down to a simple process – these five steps.

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