• 2020-bl-author-brian-curran

    How Electronic Batch Records and Device History Records Close the Digital Manufacturing Gap

    To support advanced data technologies and to compete in a modern market, manufacturers must close the digital gap on the shop floor, where critical production processes remain paper-based and disconnected. 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.

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  • 2021-bl-validation_132x132

    Simplifying Commercial Software Validation in Medtech Manufacturing

    Validation has historically been a time-consuming, painful undertaking for medtech companies that depend on commercial off-the-shelf software solutions. As that the bulk of that burden shifts away from users and onto software providers, it’s getting easier to take a risk-based approach to validation.

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  • 2021-bl-sop-review_132x132

    FDA Inspection Preparation: SOPs, Process Maps, and Gap Analysis

    With proper preparation and the right tools, a manufacturing organization can always be ready to pass a U.S. Food and Drug Administration (FDA) inspection relatively stress-free. Process mapping and gap analysis can help manufacturers not only show the FDA that a company is compliant with regulatory expectations, but also help demonstrate that standard operating procedures (SOPs) are correct and that employees understand them.

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  • 2021-bl-pharma-and-digitization_132x132

    Why is Pharma Resistant to Digitization?

    The pharmaceutical manufacturing industry resists digitization and continues to rely on paper as a single source of truth for record keeping. This outdated process is inefficient and can actually create more risk in the long run. Understand the primary causes of resistance to digitization and how to address those barriers.

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  • 2021-bl-iso-standards_132x132

    ISO Standards: Turning Hopes Into True Quality Objectives

    Don’t settle for ambiguous quality goals when you need measurable objectives that truly affect outcomes. Learn how alignment with ISO standards can turn your wishes into real quality improvements.

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  • scientists-working-on-a-digital-touch-screen-in-lab-132

    Regulatory Records Primer: Decoding the Requirements for Medical Device Manufacturers

    The U.S. Food and Drug Administration (FDA) set up the Quality System Regulation (QSR) to give medical device companies guidelines for ensuring quality, safety, and efficacy of their devices. There are many components to the QSR, but this post focuses on the requirements that apply to records.

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  • 2021-bl-risk-based-approach-suppliers_132x132

    The Role of Supply Agreements in Life Sciences Manufacturing

    In light of the COVID-19 pandemic’s disruption to the global supply chain and the urgency around manufacturers quickly delivering life-saving products, it makes sense that manufacturing organizations and their supply partners might reassess their relationships and obligations to one another to manage the results of disruption to supply chain partners.

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  • 2021-bl-supplier-scorecard_132x132

    Developing an Effective Supplier Scorecard

    Supplier performance greatly affects the cost, quality, delivery, and responsiveness of a manufacturer’s business. For any manufacturer whose product quality relies in part on a supplier’s own product or service, the organization must be able to ensure or improve high supplier performance. Supplier scorecards are a logical place to start.

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  • 2021-bl-5-ways-digital-tech_132x132

    5 Ways Digital Technology Will Transform the Supply Chain

    Digital transformation initiatives were already underway among life sciences manufacturers before COVID-19 struck, but the volatility around the global pandemic brought to light the importance of digital technologies in the supply chain. Research indicates that companies digitized many activities 20-25 times faster as a result of COVID-19. Integrating digital technologies in the supply chain has enormous implications for life science organizations.

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  • 2021-bl-risk-based-approach-suppliers_132x132

    A Risk-Based Approach to Supplier and Vendor Audits

    A manufacturer’s ability to deliver high-quality products and maintain regulatory compliance relies in part on the quality-related activities of its own suppliers and vendors. Supplier and vendor audits can be important tools for manufacturing organizations to ensure their suppliers and vendors aren’t the source of major issues in product parts or materials. Digitization can dramatically enhance supplier audits and vendor qualification audits in a number of ways.

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  • 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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