SimplerQMS

Quality Assurance (QA) and Quality Control (QC) are both essential for ensuring the quality of products and services, but they serve different roles. Our recent article explores the differences between QA and QC in detail. The article discusses the distinct roles of QA and QC, how they work together within a Quality Management System (QMS), and the role of QMS software in supporting these processes. You can read the full article to learn more about QA and QC: https://lnkd.in/dWipbd26 #QualityAssurance #QualityControl #QMS

We're #hiring a new Business Development Representative (BDR) for Danish SaaS Scale-up in Life Sciences in Manila, National Capital Region. Apply today or share this post with your network.

Choosing the right QMS software is essential for streamlining quality management processes and ensuring compliance. Our recent article provides a comprehensive guide on how to choose QMS software. The article discusses the steps and considerations necessary for selecting the best QMS software for your company. For a detailed guide on making an informed decision that aligns with your company’s needs, read the full article here: https://lnkd.in/dFWC-6tJ #QMSSoftware #eQMS #QMSSoftwareSelection

Minerva Imaging's implementation of SimplerQMS in its CDMO operations has significantly improved their audit preparedness, streamlining their approach to regulatory audits and inspections. By adopting a fully digital document repository, Minerva Imaging has been able to showcase a level of transparency and readiness that has impressed auditors. Pablo Moreno, Director of Quality at Minerva Imaging, emphasized the efficiency of the system, stating, "The good and the positive thing is that we already have electronically available documentation. So, we can forward whatever the inspectors and auditors are asking in relation to the inspection. And that is quite fast and quite efficient." This capability to project documents on a large screen in real-time during audits not only streamlines the process but also enhances the credibility and compliance of Minerva Imaging's CDMO operations. Learn more about how SimplerQMS can elevate your audit preparedness by reading the full case study here: https://lnkd.in/d-qVkW66 #AuditPreparedness #QualityManagement #eQMS #CDMO #CaseStudy #MinervaImaging 

The FDA categorizes medical devices into three classes based on their risk to patient safety: Class I, Class II, and Class III. Our recent article provides an overview of the FDA's classification of medical devices. We discuss specific examples and the regulatory requirements associated with each class. In addition, we explore how an electronic QMS can streamline the regulatory approval process. You can read the full article to learn more about FDA medical device classifications and their implications here: https://lnkd.in/dUhaxJUa #MedicalDevices #FDACompliance #MedicalDeviceClasses #eQMS

The European Union Medical Device Regulation (EU MDR) categorizes medical devices into four classes based on their potential risk of harm to users: Class I, Class IIa, Class IIb, and Class III. Our recent article provides an overview of the EU MDR classification rules, examples of devices in each class, and regulatory requirements. You can read the full article to learn more about EU MDR medical device classification: https://lnkd.in/ddCjjHUZ #MedicalDevices #EUMDR #MDRCompliance

We're #hiring a new Performance Marketing Specialist for Danish Life Science SaaS Scale-Up in Manila, National Capital Region. Apply today or share this post with your network.

Our recent article discusses the main aspects of the Medical Device Technical File (Technical Documentation). The article explains the technical file significance, requirements, content, and the role of QMS software in managing these documents. You can read the full article: https://lnkd.in/dskfQPV8 #MedicalDevice #RegulatoryCompliance #eQMS

We're #hiring a new Finance & Business Analyst in Philippines. Apply today or share this post with your network.

We're #hiring a new Administrative Assistant in Philippines. Apply today or share this post with your network.