Scaling compliance in biopharma is no small task. As regulations evolve and manufacturing complexities grow, companies need the right solutions to maintain quality, ensure data integrity and streamline processes.
Discover how ISO 9001:2015 strengthened quality management systems, emphasized customer satisfaction, and empowered leadership. Explore 7 essential internal audit checklists to streamline compliance.
Advances in technology, increased regulatory security and a growing focus on sustainability mean that compliance requirements are becoming stricter across many industries. Protecting brand reputation and preventing costly recalls are driving organizations to make company-wide compliance a top priority.
46% of companies surveyed report between 11 and 20 safety incidents annually, indicating that persistent on-site challenges are impacting workforce safety. This has a knock-on effect on product quality. Supply chain pressures and widening skills gaps further complicate these issues, making it essential for organizations to adopt proactive measures to address ongoing challenges.
To remain compliant, any organization within the life sciences sector must undertake audits. This process involves investigating, verifying, and reviewing activities related to producing and distributing products. Auditors look at everything from suppliers to manufacturing processes to documentation.
Severe financial penalties and legal headaches await medical manufacturers who fail to meet the FDA's MedWatch reporting requirements. Not to mention the downfall of your brand value. Our guide prepares you with best practices to simplify and streamline MedWatch reporting and achieve compliance at scale.
Food and beverage companies perform a delicate balancing act. Their goal is to lower the overall cost of poor quality. They want to achieve this while avoiding any compromises that might lead to increased waste, product recalls, or damage to their reputation. A quality management system (QMS) can help businesses achieve that balance.
The Occupational Safety and Health Administration (OSHA) requires formal hazard assessments for situations such as confined space work or when a job calls for Personal Protective Equipment (PPE). Conducting a Job Safety Analysis (JSA) is one way to meet these requirements, and to make any dangerous job less risky.
Audits are an important business process, but doing them manually and without an audit schedule is inefficient and risky. This article discusses the power of automation in quality audits, how automating improves efficiency, and how it influences compliance.
Inefficient quality processes can seriously impact the ability to successfully commercialize critical drugs and medical devices. This is a topic we recently wrote about in Pharma Manufacturing. Quality across the full drug development lifecycle can reduce the risk of non-compliance and save companies millions of dollars in fines, lost time and expended resources.
Build a strong QMS foundation with comprehensive QMS documentation for easy understanding, collaborative use, and automatic updates. Contact a quality expert today.
Discover the transformative journey of the Hexagon MI and ETQ partnership. Insights from Josh Weiss, President of Hexagon MI, and Vick Vaishnavi, CEO of ETQ.
Discover how implementing best practices for document control procedures can optimize efficiency and ensure compliance.
While some use the terms quality assurance software and quality management software interchangeably, they are, in fact, different things with their own distinct set of tools and methodologies. Let's explore the differences between the two software types, how each impacts your business, and whether you need QA or a QMS.
Many businesses and organizations have strict regulatory requirements they must adhere to. Regulatory agencies constantly update these requirements as new research is released and standards improve. The stakes are even higher if you’re working in an industry directly linked to health and safety, such as the pharmaceutical, medical, food and beverage, automotive, or aerospace and defense industry.
For all types of manufacturers, weakness in document control not only causes compliance issues; but it can be a major source of financial, safety and brand risk as well. Putting in place effective document control strategies should be a top priority to ensure operational excellence. This imperative was explored recently in an article in Machine Design, written by our VP, Product Marketing, David Isaacson.
Implementing enterprise quality management software is critical, but this integration process can pose several challenges. This post looks at the challenges you might face during your QMS enterprise integration and effective strategies to overcome them
Visibility is vital for any business looking to improve quality, decision-making and efficiency. In being able to see the bigger picture, it’s easier to find areas for improvement. This article explores how an enterprise quality management system (EQMS) can increase that visibility.
Strong quality management leads to higher levels of customer trust and satisfaction and enhanced operational efficiency. Still, many organizations face regulatory compliance hurdles due to slow and clunky legacy quality management systems and practices.
As we get back into our daily routines after holidays and travel, it is time to reflect on our recent ETQ Quality Vision 2023 conference. Being part of the larger HxGN Live conference — but still being able to focus on topics important to our customers — allowed us to bring the best of both worlds to attendees.
Quality management system software (QMS) streamlines quality control for organizations by documenting processes, procedures, and responsibilities. Implementing QMS enhances operational efficiency, ensures compliance with regulatory standards, and supports risk management.