CoursWorx’s Post

Dear CSV/IT/QA/GxP professionals, ISPE India Foundation is pleased to announce plans for a workshop on CSV in 2024. The workshop will focus on addressing the challenges of CSV implementation and helping the GxP industry implement value-added CSV that meets current CSA expectations. To help the panel experts tailor the workshop to address practical challenges, please fill out the following survey: [https://lnkd.in/grJ63KWU] Thank you for your time and consideration. Please reshare and respond for better reach. My sincere thanks to Uday Shetty ji for this initiation. https://lnkd.in/grJ63KWU I am confident that this workshop will effectively address the following bold statements from ISPE GAMP # The insufficient implementation of the risk-based approach (GAMP 5) in conjunction with unskilled validation/quality professionals has led to excessive time spent generating detailed test scripts/ test specifications. and gathering supporting evidence such as screenshots. # Dry running of tests to reduce execution errors to detail more in the test instructions focus on error-tree execution rather than error detection in the software/system. # Unfortunately, in many cases. ISPE GAMP 5 has not been effectively implemented in the field due to the absence of critical thinking and the use of unskilled practitioners. # Overall 'CSV is often seen mostly as an activity to secure evidence for auditors rather than as a value practice to ensure the quality of the system

Something for the Weekend! As we wrap up another busy week, I wanted to share some insights from our recent Research Quality Association (RQA) Coffee Morning session together with John Cheshire, with Hugh O'Neill as chair, where we delved into the intricate world of pharmaceutical computerized systems validation (CSV) and computer system assurance (CSA) from both a client (John) and vendor (yours truly!) perspective. Key Takeaways: - Transition to CSA: We're witnessing a pivotal shift from traditional validation models to a more dynamic CSA approach. The ongoing nature of CSA marks a significant departure from the project-focused validation methods of the past. - Balancing and aligning perspectives: It's crucial to align the viewpoints of both suppliers and clients. Our discussions highlighted the importance of standardized methodologies in supplier assessments, focusing on technical competence, regulatory compliance, and quality assurance. - Software lifecycle focus: In the realm of validation, the spotlight is increasingly on software lifecycle aspects like design, development, and hosting. This focus is essential to ensure compliance and efficacy in our ever-evolving digital landscape. - Bridging gaps with test evidence: A key discussion point was how test evidence serves as a bridge between supplier claims and client expectations, underscoring the importance of transparency and accountability. Here is a video snippet from the session for those who missed it. Stay tuned for more insights, and please don't hesitate to share your thoughts or experiences related to CSV and CSA in the comments below! #Pharmaceuticals #ComputerSystemValidation #CSA #QualityAssurance #RegulatoryCompliance #OpenNovations #RQACoffeeMorning https://lnkd.in/dXq-bV4A

Investing the time to understand which regulations you must comply with, which are advantageous, and which, are the gold standard, is a crucial starting point for your CSV journey. This knowledge lays the groundwork for your CSV roadmap, helping you pinpoint the specific validation activities essential for compliance. https://lnkd.in/gmCkz3-R

This product is 21 CFR Part 11 Compliant 🥲… Thank you, Charlie Wakeham, for this amazing blog. Only 20 years of hard work and knowledge could summarise those points so well. I'm glad you've unleashed those thoughts and clarified the GAMP position in the regulatory, engineering, quality, and patient safety world! #Expertise #GAMP #RegulatoryInsights #EngineeringExcellence #QualityAssurance #PatientSafety #PharmaceuticalIndustry #IndustryLeadership

FDA transitioning from CSV to CSA for computer systems in medical device production/quality systems. 🔹 CSV validates system compliance with regulations, while CSA uses a risk-based approach for high confidence in system performance. 🔹 CSA aims for efficient use of resources by applying the right level of rigor based on risk. 🔹 Categories of computerized systems include infrastructure, standard components, and custom applications. 🔹 Risk management in CSV focuses on patient safety, product quality, and data integrity. 🔹 CSV documentation includes validating software, acceptance criteria, method of validation, and stakeholders. 🔹 CSA process involves identifying intended use, risk-based analysis, determining assurance activities, and establishing records. 🔹 CSA testing methods include unscripted for low/medium risk components and scripted for high-risk features. 🔹 Benefits of CSA include reduced cycle times, focused testing on SW quality, and better use of supplier qualification. 🔹 Transition to CSA signifies a critical thinking-driven and efficient approach in computer system validation. #FDA #CSV #CSA #QMS #QualityAssurance #Compliance 💻🔒👩💻

***New Web Seminar Course Alert*** EU Guideline on Computerised Systems and Electronic Data in Clinical Trials February 28, 2024 | 2:00 PM - 3:30 PM Eastern ✔️ Explore the distinctions between the EU Guideline and other computer systems validation guidance and methods. ✔️ Recognize the role of metadata in ensuring the integrity and traceability of electronic data. ✔️ Grasp the significance of ALCOA++ in maintaining data reliability. ✔️ Describe risk management methods outlined in ICH E6. ✔️ Differentiate between investigator and sponsor systems, understanding their respective roles and responsibilities within the guideline’s framework. More information and registration: https://lnkd.in/em-qnZ6V #clincialtrial #clinicalresearchtraining #clinicalstudies #clinicalresearchassociate #clinicaldatamanagement #alcoa #ich

Navitas Life Sciences offers #validation services #CSV for the #pharmaindustry #drugdevelopment #drugsafety #regulatorycompliance #costeffective #systemvalidation #pharmaceuticals #biologics

Effective Computer System Validation (CSV) plays a crucial role in ensuring the quality of drugs. Navitas Life Sciences, we pride ourselves on supporting organizations as we work to transform validation services using the 3 Ps...People, Process, and Platform. We can provide global resourcing, support specific projects, or serve as a strategic validation partner. If you would like to learn more about our Validation framework and engagement models, then please click here: https://lnkd.in/dSvsRe69 #CSV #AuditReadiness #CSA #RiskBasedApproach #ValidationasaService #DrugEfficacy #QualityAssurance #ValidationExcellence

Computer System Validation (CSV) plays a pivotal role in ensuring the accuracy and reliability of clinical trial data: 1- What is CSV? * CSV is a documented process that ensures computer systems perform consistently and produce results meeting predetermined specifications. * It bridges the gap between technology and regulatory compliance in FDA-regulated industries. * By validating systems, it helps maintain data integrity, patient safety, and product quality, thereby minimizing the risk of recalls and regulatory actions. 2- Key Components of CSV in Clinical Trials: Data Integrity: * CSV processes ensure accurate and reliable data. * This involves generating precise data, preventing unauthorized access or changes, and maintaining audit trails. Change Control: * Robust change control processes are essential. * Any system changes (including software updates) must be well-documented and controlled to maintain system integrity. Validation Strategy: * Define the system, identify key users, outline intended use, and detail the validation approach. Testing and Documentation: * Rigorous testing and comprehensive documentation are critical for system validation. Continuous Improvement: * Regularly assess and enhance CSV practices to adapt to evolving requirements. Remember, accurate clinical trial data is the bedrock of scientific progress and patient well-being. Let’s champion robust CSV practices! 🚀🔬 #CSV #ClinicalTrials #DataIntegrity Disclaimer: The views expressed here are solely my own, based on personal knowledge and work experience. My organization is not associated with these opinions. This content is for informational purposes only; readers should seek professional advice as needed.

This article must be read by every one in CSV (Irrespective of your exp) and all those who have anything thing to do in regulated space. Let me ask you a question, how many of you can speak for 1 min on difference between Quality and compliance, often using them interchangeably. Charlie Wakeham explains you why they are not same instead one is by product of another. Read it, twice.