October 12, 2021
By James Jardine, GxP Lifeline Editor, 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.
September 30, 2021
By James Jardine, GxP Lifeline Editor, 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.
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.
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.
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.
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.
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.
September 16, 2021
By Nicolle Cannon, Founder & CEO, Cannon Quality Group
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.
September 14, 2021
By David Butcher, Staff Writer, MasterControl
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.
September 13, 2021
By Sarah Beale, Staff Writer, MasterControl
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.
September 10, 2021
By David Jensen, Staff Writer, MasterControl
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.
September 9, 2021
By Dr. Dirk Stynen Owner, President and Principal Consultant, Qarad
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.
September 7, 2021
By David Butcher, Staff Writer, MasterControl
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.
September 3, 2021
By James Jardine, GxP Lifeline Editor, MasterControl
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.
August 26, 2021
By James Jardine, GxP Lifeline Editor, MasterControl
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.
August 24, 2021
By Sarah Beale, Staff Writer, MasterControl
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.
August 23, 2021
By Hitesh Patel, Managing Consultant, Enterey Consulting
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.
August 19, 2021
By Samir Patel, Project Lead - Digital Systems, Sequence
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.
August 17, 2021
By David Jensen, Staff Writer, MasterControl
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.
