GxP Lifeline

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

November 18, 2021 By Brian Curran, Senior VP of Strategic Growth, MasterControl

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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Simplifying Commercial Software Validation in Medtech Manufacturing

November 17, 2021 By James Jardine, Staff Writer, MasterControl

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

November 16, 2021 By David Butcher, Staff Writer, MasterControl

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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Why is Pharma Resistant to Digitization?

November 11, 2021 By James Irons, Director of Strategic Development, and Samir Patel, Project Lead - Digital Systems, Sequence

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 This outdated process is inefficient and can actually create more risk in the long run.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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ISO Standards: Turning Hopes Into True Quality Objectives

November 9, 2021 By James Jardine, Staff Writer, MasterControl

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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Regulatory Records Primer: Decoding the Requirements for Medical Device Manufacturers

November 4, 2021 By David Jensen, Staff Writer, MasterControl

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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The Role of Supply Agreements in Life Sciences Manufacturing

November 2, 2021 By David Butcher, Staff Writer, MasterControl

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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Developing an Effective Supplier Scorecard

October 28, 2021 By David Butcher, Staff Writer, MasterControl

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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5 Ways Digital Technology Will Transform the Supply Chain

October 27, 2021 By David Butcher, Staff Writer, MasterControl

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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A Risk-Based Approach to Supplier and Vendor Audits

October 26, 2021 By David Butcher, Staff Writer, MasterControl

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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Tips to Gain Executive Support for a Digital QMS

October 14, 2021 By Dale Thompson, Staff Writer, MasterControl

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

October 12, 2021 By James Jardine, Staff Writer, MasterControl

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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5 Tips for a Successful ISO 9001:2015 Certification Audit

October 7, 2021 By David Jensen, Staff Writer, MasterControl

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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5 Things to Know When Using Computerized Systems in Clinical Trials

September 30, 2021 By James Jardine, Staff Writer, MasterControl

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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Identifying and Preventing Common Data Integrity Issues

September 28, 2021 By David Jensen, Staff Writer, MasterControl

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

September 27, 2021 By David Jensen, Staff Writer, MasterControl

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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Why Automation Is Essential for Document Control Compliance

September 23, 2021 By David Jensen, Staff Writer, MasterControl

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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Change Management: Enabling Successful Adoption

September 21, 2021 By John Chiechi, Manager, Enterey

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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Writing and Enforcing GxP SOPs for Compliance

September 20, 2021 By Sarah Beale, Staff Writer, MasterControl

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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Cybersecurity in Medical Device Development

September 17, 2021 By Seyed Khorashahi, executive vice president of medical devices and CTO at Regulatory Compliance Associates (RCA) Inc.

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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