compliance group
Compliance Group is a full spectrum service provider to Life Sciences, Tobacco and Cosmetics industries. Our team is comprised of Industry Leaders in Technology, Regulations and Life Sciences processes.
From Root Cause to Real Cause. Key Elements of a Quality Management Software. FDA 483 Observations vs. Warning Letter. Moving to Enterprise Agile – Seven lessons learned in Agile. 7 Key Elements of a Quality Management Software. With the growing competition, quality leaders are trying innovative ways to enhance the product/service quality.
Quality is not an option, and in fact, it does not happen by chance. It is a prerequisite for any organization to function efficiently and satisfy customer needs. From Root Cause to Real Cause. Let’s face it; nothing new can be said about root cause analysis (RCA).
Standard RCA techniques have been around for decades, and before them being documented and referred to as RCA techniques, they were being employed. It is human to ask why. While it may not be human to ask why five times, it is natural to get to the bottom of problems. Unfortunately, in the regulated world of medical device and pharmaceutical manufacturing, there is a temptation to require intense documentation to prove that not only was the real root cause found but that it was accomplished by following strict processes. The emphasis on establishing the work was done often takes away from real RCA and actual problem-solving. Why is Non-Conformance Management important? Introduction FDA and ISO have a defined set of guidelines to enable organizations to handle their quality processes effectively.
Non-Conformance according to ISO 9001:2015The organizations certified for ISO 9001 are expected to ensure error-free quality processes and stringent mitigation plans to handle errors. In addition, the regulations mandate regular quality checks through internal and external audits to comply with efficient and better product delivery.
Quality-Assurance (vs) Quality-Control. As the English saying goes, “Potato, Potato” doesn’t translate well in the written form.
Still, it’s saying the same vegetable but with a different pronunciation, meaning it doesn’t matter how you say it; it’s the same veggie. Accelerate collaboration with unified requirements management. Are you prepared for the latest version of ISO 14971:2019? Navigating the EU MDR Maze. Compliance Group’s prior CSA presentations with FDA & Clients. Your Quality Management is Failing and Here's Why.
Earlier this year, I lived by a legit rocket scientist for nearly 30 years.
This guy was amazing, beyond the obvious reasons! He was very conversant, generous, a helping hand, and even an ecclesiastical leader for our church, carving out an extra 20 hours per week to help his congregation. He had some stories from his rocket scientist days. Most of these stories he was not able to share since most were classified as Top Secret. He worked indirectly for Thiokol, an infamous name for rocket propulsions, namely, the Challenger Space Shuttle explosion. Above was a horrific example of failed Quality Management Process. The hardware failure of a solid rocket booster (SRB) ‘O’ ring was cited as the immediate, mechanical cause, but human culpability lay behind the launch’s decision-making process.
Thiokol, the subcontractor behind the ‘O’ rings’ supply, warned NASA of the potentially adverse effects of cold temperature on the ‘O’ rings performance a day before launch. Everything about FDA’s draft guidance on Computer Software Assurance (CSA) 21 CFR Part 11 ERES Requirements. Transform CSV using Polarion's Automated Risk-Based CSA approach. FMEA for Risk-Based Approach CSA. CAPA Process Improvements for Medical Devices. Errors are usually a part of any process, action, or activity.
There is always a percentage of error that happens. The practice must be to refine it and bring the errors down as low as humanly possible. To adhere with industry regulations and to remain compliant with various policies, quality processes of organizations have multiple checks and internal policies in place to address the non-compliances and errors that occur during the lifecycle of manufacturing a product. The focus of these processes is to address the errors, analyze them, fix them and ensure that they do not occur again. Often during this process, the regulatory burden makes it difficult for quality process individuals to provide their complete focus to solving the errors in a way that they are traceable backward, permanently fixed, and provide insights about any matters that need to be addressed immediately.
One of the most talked-about and feared issues in a quality process is the CAPA. What is the difference between Quality Management System and QSM? Q & A session with the FDA on FDA’s draft guidance Computer Software Assurance. What is changing at the FDA in terms of Quality vs Compliance? The Future of Quality Management and FDA Case for Quality initiatives. FDA 483 Observations vs. Warning Letter. Companies in the life sciences, food, and cosmetics industries are all too aware of how fickle the market is, how dynamic their studies and those under investigation are, as well as their timelines for releasing a specific medical device or medication.
Adding to that, how your quality processes are going, or not going, and you have a recipe for FDA 483 observations or worse, FDA Warning letters 2021. How do companies get to this point? What are the differences? How does a company avoid them? Everything about FDA’s draft guidance on Computer Software Assurance (CSA) CSA Revolution Webinar Series Episode 1 with Gilead Life Sciences. CSA Revolution Webinar Series Kickoff with the FDA. CAPA Process Improvements. Introduction Errors are usually a part of any process, action, or activity.
There is always a percentage of error that happens. The practice must be to refine it and bring the errors down as low as humanly possible. To adhere with industry regulations and to remain compliant with various policies, quality processes of organizations have multiple checks and internal policies in place to address the non-compliances and errors that occur during the lifecycle of manufacturing a product. The focus of these processes is to address the errors, analyze them, fix them and ensure that they do not occur again. Often during this process, the regulatory burden makes it difficult for quality process individuals to provide their complete focus to solving the errors in a way that they are traceable backward, permanently fixed, and provide insights about any matters that need to be addressed immediately.
CSA Revolution Webinar Series Episode 2 with Johnson & Johnson. 7 Common Medical Device Regulatory Compliance Problems. From hearing aids to ultra-tech pacemakers, the medical device industry is a ground-breaking and innovative field full of opportunities.
Though the manufacturers are passionate about delivering high-quality and safe products to market, uncertainty lies ahead. The new emerging regulatory compliance services, complex reimbursement rules are engraving the companies to face a cutting-edge competitive scenario. These challenges have called the medical device industries to produce cost-effective products, streamline the operations in line with regulatory compliance and bring in innovative devices more quickly. With the emerging technologies, medical devices are a cost factor despite their long-term cost-saving modes and improved patient safety measures. However, medical device manufacturing companies should take precautions to avoid compliance regulations issues. CSA Revolution Series Episode III with Fresenius Medical Care, FDA, & Siemens Life Sciences. Common Medical Device Regulatory Compliance Problems. CSA Revolution Webinar Series Episode 4 with MedTronic.
CSA Revolution Webinar Series Episode 6 with Lantheus & FDA. CSA Revolution Webinar Series Episode 5 with Boston Scientific. What is the FDA’s approach to regulating AI/ML in Software as a Medical Device. CSA Revolution: Season Two, Episode I with Data Integrity & CSA Experts. CSA Revolution Season 2 with FDA Discusses Data Integrity & CSA Application. CSA Season Part 2 with FDA Discusses Data Integrity & CSA Application. CSA Revolution - Johnson & Johnson Transform Software Testing Defects. 3 eQMS Tips for an Effective Quality Process.
3 eQMS Tips for an Effective Quality Process. Save Quality Time! Go Paperless. CSA Fast Pass to Automation. AL ML and FDA Quality Management System. Document Management Software Solutions - iQDMS. Standard Operating Procedure. Audit Support - Audit Readiness Assessments and comprehensive Remediation Services. Computer System Validation in Pharmaceutical Industry.
What is the FDA's approach to regulating AI/ML in SaMD (software as a medical device)? - complianceg. As the quote goes, “Necessity is the mother of invention.”
Ironically, we don’t know who invented that quote. It became an amalgam of people from Plato to a 19th-century theologian. According to the FDA’s site, their first Medical Device approved was in 1976 through their CDHR division (Center for Devices and Radiological Health) per their 21CFR Parts 800-1299. As we know, medical devices fall into three categories, from low risk to high risk: Class I, II, and III Per the Int’l Med Device Regulators Forum (IMDRF), the need for regulating SaMD, this new form of med device, came about as long ago as 2013, again through an amalgam of regulated elements within the med device world.
“SaMD” even reaches as far back as the 60s with Lockheed’s consideration of getting the first computerized information-handling system in the hospital sphere. And do we know who the first company was to be approved by the FDA as a SaMD? Would SaMD do the same? Data Integrity (DI) Assessment, Remediation and Support Services. What Makes for a Great Validation Lead. Why is an electronic Quality Management System (eQMS) important? Need a Great Validation Lead, Compliance Group has them? Best approach to achieve an FDA/MDIC approved Quality Management System. CSA - Is Computer Software Assurance Cheating? FDA 21 CFR Part 11 ERES Checklists. FDA's New Computer Software Assurance. Software as a Medical Device - Full Spectrum SaMD SOP & Execution Services. Step by Step approach to achieve an FDA/MDIC approved Quality Management System. Step by Step approach to achieve an FDA/MDIC approved Quality Management System.
Why is an electronic Quality Management System (eQMS) important? CSA - Is Computer Software Assurance Cheating? FDA 21 CFR Part 11 ERES Checklists? Do this instead! FDA's New Computer Software Assurance - Impacted SOPs. Get in Touch with Compliance Group in USA. AL ML and FDA Quality Management System. Compliance Group Recent Press Releases and News Stories. Libertyville, IL, USA, March 31, 2021- Compliance Group Inc., an ISO 27001 certified company and a trusted life sciences industry partner, today announced the launch of iQuality e-QMS (iQMS), a suite of digital Quality Management System products comprising QMS (Quality Management System) and Document Management System (DMS). iQMS, a Software as a Service (SaaS) hosted on SOC 2 Type II and ISO 27001 certified iQuality Cloud, enables Life Sciences companies to improve product quality by leveraging the latest advancements in Artificial Intelligence and digitalizing the entire process for customers.
White Paper Registration - CSA & CSV Case Studies for Life Science Industry. Presentation material: FDA Data Integrity-CSA Part Two Webinar (Mar 16 2021) Presentation Material used in this live webinar with Data Integrity panelists, on March 16. During the webinar, we learnt how CSA can be adapted to benefit your organization and the application of Data Integrity. FDA Consultant Partners. Careers - Compliance Group is Fastest growing Life Sciences Service Provider. Leadership - FDA Compliance Leaders in Compliance Group. CSA Revolution Webinar Series. Leadership - FDA Compliance Leaders in Compliance Group. Industry's Best Quality Compliance Services. Polarion - Paperless Computer System Validation Software. Compliance Group. eQMS Software for Life Sciences Industry. Flexible and Custom Engagement Models for Life Sciences Industry. FDA Computer Software Assurance. End-to-end Services for the Life Sciences Industry. Global Leader in Quality Compliance Solutions for Lifesciences Industry.