ERA Sciences

🔍 ERA Sciences continues to support organizations on their journey to data integrity excellence in life sciences. Our team regularly develops fresh, expert-driven content focused on #GxP computerized systems compliance and data integrity best practices. 💡 From statistical software validation to comprehensive system assessments, our new articles provide practical guidance for organizations navigating the complex landscape of regulatory requirements. Whether you're a #QA professional, #validation specialist, or #clinical research leader, you'll find valuable insights to enhance your compliance strategy. 📚 Discover our latest resources on data integrity, validation approaches, and regulatory preparedness on the ERA website. We're committed to helping you build robust, compliant processes that stand up to #regulatory scrutiny while driving operational excellence. Check out our articles today https://lnkd.in/erDVkEGX

🔬 At ERA Sciences we understand that navigating Life Sciences challenges can be complex . We are always seeking better collaborative dialogue & industry Insights 🌟to drive client progress. Since 2023 we have been part of Life Science Fusion Ireland - a group of vendor companies who have come together to explore and address critical industry challenges, always keeping patient safety and product quality at the heart of our discussions. By bringing together diverse subject matter experts, we're creating a collaborative space to tackle the most pressing challenges in life sciences—with patients always in focus. Check out the companies involved in our article ⬇️ https://lnkd.in/eNRD6EQw #LifeSciences #IndustryDialogue #GMP #Healthcare #Innovation

🙏At ERA Sciences, we are continually humbled by the extraordinary work of life sciences companies. Every day, our clients are at the forefront of transforming scientific discovery into tangible hope—developing treatments that extend lives, alleviate suffering, and push the boundaries of medical innovation. Behind every breakthrough medication is a complex ecosystem of dedicated researchers, clinicians, engineers, quality, IT and support teams who work tirelessly to solve some of humanity's most challenging health challenges. From rare genetic disorders to complex chronic conditions, these companies are not just developing products; they are creating pathways to healing and resilience. ERA Sciences takes pride in being a small but critical part of your journey. This is more than business. This is about supporting those who are actively rewriting the narrative of what's possible in human health. Check our our latest blog article from Andy O' Connor making sure that your GxP computerized systems are managed appropriately. https://lnkd.in/ePDapkeh

📆 Another day of data integrity training at SGS is ready to start. Twenty empty seats await—each one a testament to SGS dedication to professional growth and data quality. 🌍But this isn't just another training session; it's a powerful statement about organizational culture. From the executive team to front-line staff, SGS are investing in learning - 'data integrity' isn't just a checkbox—it's a critical business enabler providing assurance to patients and clients. What sets SGS apart isn't just their willingness to learn, but their proactive approach to embedding data quality and integrity into every aspect of their GMP operations with cross-functional commitment to continuous data integrity improvement. We even get to challenge the + in ALCOA++ across laboratory scenarios. ERA Sciences are proud to be part of the SGS data integrity journey. Over the week we will train 💫 80 people including senior management - data integrity really is a team effort. Thanks to Darren Mc Connon for facilitating the learning sessions and Dr. Eva Kelly for providing the training. #DataIntegrity #ProfessionalDevelopment #OrganizationalExcellence #ALCOA

🔍 Are you a Life Sciences professional committed to quality and data integrity? Do you want to unlock the basics of Data Integrity in just 10 minutes with our ALCOA Fundamentals Quick Fire Module? ✨ Try our FREE Learning Experience 🎯 Master Legibility Principles Watch our video to discover how this lightning fast module can transform your data management skills. First 500 participants get a Special 50% off code for our best-selling Fundamentals Course. 👉 Click the link https://lnkd.in/eUDBMZYf to start your free learning journey now #DataIntegrity #GMP #ContinuousLearning #ALCOA

Well done to Andy O' Connor on his recent presentation at the Appsilon GXP Validation Summit on the topic 'Implementing and Qualifying a GxP-Compliant RStudio Environment on AWS' Andy spoke about applying industry best practices and a risk informed approach 'GAMP 5 Ed 2' to the controlled implementation of a GxP Computerized system for clinical trials. If you want to watch a replay check it out here: https://lnkd.in/erwD8j_M Great response to this talk and how understanding the platform layers vs the software layers really does allow risk conversation to be focused appropriately

🚀 Excited to Announce: GxP Validation Summit: Clinical Software Development 🚀 We’re thrilled to highlight Andy O’Connor will be sharing his insights at the upcoming GxP Validation Summit Virtual Event hosted by Appsilon! 📅 Date: 20 November 1pm - 7pm GMT 📍 Location: Virtual Appsilon and ERA Sciences were recently engaged to implement a GxP-compliant instance of RStudio for a mid-size life sciences company, providing a robust environment within AWS for developing complex, reproducible statistical models in support of pharmacometric studies within Clinical Pharmacology. This case study outlines the risk-based approach to GAMP standards, classifying the statistical software installation as GAMP Category 1 infrastructure to streamline compliance. Whether you're in clinical research, pharma operations, or compliance management, this is your opportunity to learn from one of the industry's thought leaders. 💡 Ready to transform how your organization approaches clinical trials? Don’t miss out! 👉 Register here: https://lnkd.in/erwD8j_M Let us know in the comments what you’re most excited to learn! #PharmaInnovation #ClinicalTrials #RingCentral #DataTransformation #Leadership

Ready to transform the way you handle clinical trial data, regulatory submissions, and GxP compliance? The GxP Validation Summit will give insights on these topics, the use of R language and more. 🌟 Hint: The conference is FREE and digital materials will be available afterward. Check out the full line-up of inspiring speakers including Andy O' Connor's talk "Implementing and Qualifying a GxP-Compliant RStudio Environment on AWS: A Case Study" https://lnkd.in/erwD8j_M

Excited to welcome 🎉 John O. to the ERA Sciences team! John brings a wealth of experience in quality control, LIMS administration, and master data creation and maintenance - a powerful combination of data integrity, quality, validation and software assurance expertise to support our life sciences clients. John's background includes ensuring product quality and compliance within the industry, with a strong foundation in analytical skills and attention to detail. John has contributed significantly to both laboratory and site operations, helping deliver life-saving medicines to patients with a relentless focus on 🏥 quality and 🔒 data integrity. Previously providing day-to-day LIMS support for QC labs and supporting manufacturing across multiple production suites, ensuring robust 🔍 software validation and 📜 regulatory compliance makes him at huge asset to our team. John O. will be invaluable as we continue to grow and deliver exceptional results. 🎉 #NewHire #QualityControl #LIMS #DataIntegrity #ValidationAssurance #LifeSciencesInnovation #QualityAssurance #RegulatoryCompliance

Excited to welcome 🎉 John O. to the ERA Sciences team! John brings a wealth of experience in quality control, LIMS administration, and master data creation and maintenance - a powerful combination of data integrity, quality, validation and software assurance expertise to support our life sciences clients. John's background includes ensuring product quality and compliance within the industry, with a strong foundation in analytical skills and attention to detail. John has contributed significantly to both laboratory and site operations, helping deliver life-saving medicines to patients with a relentless focus on 🏥 quality and 🔒 data integrity. Previously providing day-to-day LIMS support for QC labs and supporting manufacturing across multiple production suites, ensuring robust 🔍 software validation and 📜 regulatory compliance makes him at huge asset to our team. John O. will be invaluable as we continue to grow and deliver exceptional results. 🎉 #NewHire #QualityControl #LIMS #DataIntegrity #ValidationAssurance #LifeSciencesInnovation #QualityAssurance #RegulatoryCompliance