Assurea

Assurea serves as the Quality and Computer System Validation Unit for fast growing clients with tight timelines in the biotech and pharmaceutical industry! 💥🚀 See how Assurea's team of dynamic consultants can support your company as you go from clinical to commercial. For an extensive list of our services, contact us at mail@assureallc.com or book a call! 📱 https://assureallc.com/ #biotech #pharma #cdmo #consultingservices #qualityassurance #qualitymanagementsystem #computersystemvalidation #gxp #commercialization #csa #cellandgenetherapy

The Assurea Weekly: Happy Holidays ! ✨🎆 🌟As the year wraps up, we want to take a moment to thank our amazing partners, clients, team, and network. Your support and collaboration have meant so much to us, and we’re grateful to be on this journey together. 🌟 We wish you a holiday season full of joy, peace, and time well spent with loved ones. Here’s to an exciting and innovative year ahead in 2025! 🎇 #beassured #holidayseason #newyear2025 #celebration #thankyou #partnerships #teamwork

We are excited to highlight Ricardo Valdes, who is a CSV Engineering Manager at Bristol Myers Squibb as our #Rootingforyou Ambassador! ⚙️ 🖥️ ✨ Read below what Rooting For You means to him and how he encourages others to celebrate their accomplishments: "To celebrate my successes, I started a personal tradition a few years ago: each December, I take time to reflect on and list all my accomplishments from the year, allowing myself to truly appreciate them. I also encourage my family and close friends to do the same. This “Rootingforyou“ series has inspired me to expand my circle of influence and consider inviting even more people, including colleagues, to join in this reflective and celebratory tradition." We are #Rootingforyou 👏 #leadership #biotech #CSV #engineering #celebration #accomplishments #inspiration #motivation #pharma

Acompáñanos a conocer algunas impresiones sobre nuestro evento ISPE LATAM 2024 en la Ciudad de México, organizado por lo affiliates de ISPE Argentina, ISPE Brasil e ISPE México Affiliate en noviembre pasado. ¡Gracias a nuestra querida amiga Tanya Sharma por tomarse el tiempo para realizar estas entrevistas entre los asistentes! #ISPELATAM #ISPELATAM24 Assurea

The Assurea Weekly: CSV 101 - The Basics 🖥️✨ 📄What is Validation? It's the documented proof that a system operates within specified parameters for its intended use. CSV Lifecycle Phases: 💡Concept Phase: Identify the need for a system and assess initial risks. 📊Project Phase: Finalize resources and documentation; this is where most activity occurs! ⚙️Operation Phase: The system is actively used, with ongoing validation updates as needed. 🚮Retirement: Safely decommission the system and manage GxP data migration. Key Roles in CSV:  🔹Process Owner: Defines system requirements and evaluates risks.  🔹System Owner: Ensures system maintenance and security.  🔹Validation/CSV Representative: Manages validation documentation.  🔹Quality Representative: Ensures compliance with regulations. 📋Critical Deliverables Include: GxP Assessments, User Requirements Specifications, Validation Plans, and more! ➡️Read the full article by Justin Dubinsky: https://lnkd.in/e3TJhGcQ #computersystemvalidation #CSV #digitalcompliance #validation #GxP #pharma #biotech

We are thrilled to highlight Tania Incitti, who is a Associate Principal Scientist at AstraZeneca, as our #Rootingforyou Ambassador! 🥼 ✨ 📖 Read about the question she asks her peers to foster a deeper understanding of their perspective: "In meetings, I like to explain the rationale behind my thoughts, and encourage my colleagues to do the same, to make sure everyone feels comfortable sharing. At the end of the meeting, I usually ask, 'Did you get everything you needed from our chat?" We are #rootingforyou 👏 #leadership #STEM #biotech #pharma #womeninscience

The Assurea Weekly: Streamlining Validation with a Risk-Based Family Approach 🖥️ Validating multiple identical systems? Instead of duplicating efforts on each asset, consider a risk-based family approach to save time and resources without compromising compliance. What is a System Family? Systems with: ✅ Identical hardware & software versions ✅ Same intended business use Efficient Testing: 🔹 Leverage tests from the "First-in-Family" (FIF) unit when risk is low. Documentation Simplified: Plans & assessments? ✅ Family level. Testing & reports? ✅ Individual asset level. 💡 The result? A streamlined validation lifecycle that is efficient with each additional system. ➡️ Read the full article by Justin Dubinsky: https://lnkd.in/eqT_gKux #validation #riskmanagement #efficiency #compliance #CSV #computersystemvalidation #familyapproach #strategy

Join Us for a Rooting for You Workshop! 🌟 Assurea is thrilled to collaborate with ASQ - World Headquarters Women in Quality for our #Rootingforyou Workshop, facilitated by our co-founder, Tanya Sharma. Together, we’ll explore goal-setting strategies and engage in interactive roundtable discussions designed to help you set practical goals and take confident steps toward turning them into reality. 📅 Date: Tuesday, December 10, 2024 📍 Location: NC Biotech Center, 15 TW Alexander Dr, Durham, NC 27703, USA ⏰ Time: 5:30 PM - 8:00 PM EST Join us for an evening of inspiration, self-reflection and goal setting for 2025 and beyond! ➡️Register: https://lnkd.in/dpeqm-dc Wendy Haines, PhD, DABT, ERT, ASQ CQA, ASQ FELLOW Maria Mahrukh  #goalsetting #workshop #womeninquality #pharma #biotech #journalprompts #confidence

The Assurea Weekly: Happy Thanksgiving from all of us at Assurea! 🍁 To our amazing clients, our incredible Assurea team, and everyone who supports us: Thank you for trusting us and believing in our vision. We are gratitude to everyone who makes our journey so meaningful. ✨ Wishing you and your loved ones a joyful Thanksgiving filled with love, gratitude, and plenty of pie!🥧 #thanksgiving #gratitude #teamwork #thankyou

𝐌𝐲 𝐫𝐞𝐟𝐥𝐞𝐜𝐭𝐢𝐨𝐧𝐬 𝐨𝐧 𝐛𝐮𝐢𝐥𝐝𝐢𝐧𝐠 𝐀𝐬𝐬𝐮𝐫𝐞𝐚, 𝐘𝐞𝐚𝐫 𝟯! As the year comes to a close, I'm incredibly grateful. I’m energized every day by the amazing people I work with and connect with—it wouldn’t be possible without ya'll. Gary Mott once said, “Year 2 is like putting out a second album.” Year 3? Our show is on the road. Year 4? We aim to expand our world even further! I’m especially excited about 𝗥𝗼𝗼𝘁𝗶𝗻𝗴𝗙𝗼𝗿𝗬𝗼𝘂—next year, we’ll be providing STEM kits to children in India and partnering with companies that share our mission. One thing I’ve focused on this year is challenging the rules and diversifying my thinking. Here are a few of the “rules” I’ve broken: 🔹 “Don’t work with family.” My sister is a co-founder at Assurea. 🔹“Don’t hire your friends.” Assurea’s first employee is one of my best friends. I'm going to hire many more friends :) 🔹“Don’t give away your secret sauce.” I’m an open book—ask me anything. 🔹“You need at least 5–7 core values for your company.” We have one: Transparency. 🔹“Power dressing = suits.” I’m redefining it with colors, florals, and individuality. 🔹You need to " Wow" everyone with your story. I keep it simple and brief. Being a better listener is way more important ( and the world needs a lot more of) This year has also taught me that good and bad will always coexist. Grief doesn’t have a timeline, and I’m so thankful for those who stood by me through life’s hardest moments and celebrated the happy ones too. The key is to embrace life’s contradictions and keep showing up. Here’s to another year of growth, connection, and breaking the rules. 💜 Ready for 2025. Krisha Patel Assurea #beassured #IT #CSV #computersystemvalidation #hello2025 #reflections