• 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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  • engineer-showing-automation-system-132

    3 Key Elements to Data Security and Quality Control for Pharma Labs

    Data integrity in the drug industry is a vital element to ensure the safety, efficacy, and quality of drugs. Data integrity has remained an industry buzzword for many years, but the experience the industry has gained from shortened timelines of COVID-19 vaccine development and manufacturing has further strengthened its importance.

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  • 2021-bl-cfr-part-11_132x132

    20 Years Later, 21 CFR Part 11 is More Relevant than Ever

    The U.S. Food and Drug Administration’s (FDA) 21 CFR Part 11 guidance made electronic records and signatures as valid as paper records and handwritten signatures. The guidance changed the dynamic of data and records management by advocating modernized technology in the life sciences industry.

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  • 2021-bl-matt-lowe_132x132

    How to Not Fail an Inspection

    When I worked for medical device manufacturers, I experienced more than my fair share of audits and inspections. Even though we had good systems in place and strived for compliance, we still frequently weren’t prepared. If we had used connected digital systems, we could’ve saved ourselves a lot of worry and problems.

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  • 2021-bl-regulatory-affairs_132x132

    Regulatory Affairs & Regulatory Operations: The Air Traffic Control Tower of Life Sciences

    The roles of regulatory operations professionals in the life sciences aren’t much different than those of air traffic controllers. They’re both focused on ensuring the safety of patients or passengers. Find out why regulatory operations experts are critical to companies’ speed of success and discover how advanced digital tools enable them to get products to more markets faster.

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  • 2021-bl-batch-record-challenges_132x132

    How to Solve 3 Common Batch Record Challenges

    Life sciences manufacturers' production processes should be assets, not liabilities. Yet too many manufacturing companies continue to allow their batch records to become liabilities by using manual, often paper-based systems that are error-prone, disconnected, and limited in the operational insights they provide. Here are three common batch record challenges manufacturers encounter and some practical ways an electronic batch record (EBR) solution can resolve them.

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  • 2021-bl-evolution-med-device_132x132

    The Evolution of Medical Device Clinical Trials: Adapting to Regulatory Changes

    Regulatory shifts and the ever-accelerating pace of innovation are necessitating a new approach to clinical investigations of medical devices. Learn about the unique regulatory pathways that devices traverse and why recent updates to compliance standards are calling for risk-based clinical strategies.

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