Veeva R&D Summit R&D SummitSeptember 16-18 | Philadelphia ​NNIT look forward to meeting you at Veeva R&D Summit in Philadelphia. Visit our booth for an informal talk about how we can help you enabling the full potential of Veeva’s platform. We believe that the future for Regulatory Affairs is bringing processes and data together in unified platforms, to benefit both compliance and operational effectiveness. A platform that makes this possible is Veeva. NNIT is a global end-to-end Veeva implementation partner facilitating the process from advisory to implementation. Furthermore, we support optimizing usage of existing Veeva applications. And we have participated in several Veeva projects for large and medium sized pharmaceutical companies. Moreover we are a global life sciences system integrator that supports and operates critical life sciences IT. About the conference Veeva R&D Summit is an annual gathering of pharma, biotech, and medical device and diagnostics leaders in clinical, regulatory, quality, and IT. Join more than 1,300 life sciences leaders and experts to share best practices and see what’s coming next in the industry. Read more about the conference here...
SAP Innovation Forum Nordics 2018 Innovation Forum Nordics 2018September 19-20 | Copenhagen ​NNIT are goldsponsor of the upcoming SAP Innovation Forum Nordics, taking place in Copenhagen on 19-20 September this year. This two day event will bring together the entire Nordics ecosystem of SAP users, partners and solution experts and offers the opportunity to explore how digital transformation via SAP solutions can mean that process excellence and highly strategic business models become achievable for your firm. The event will cover key topics such as SAP Leonardo, Internet of Things, Next Generation ERP, HR transformation, SAP S/4HANA and much more. Read more about the conference here
Conference: Computer Systems Validation & Data Integrity Compliance Congress Computer Systems Validation & Data Integrity Compliance CongressDec 3 -5 | Washington D.C. The FDA has issued many Warning Letters emphasizing CSV non-compliance. These serious findings include; having interrupted, missing, deleted and lost data; inadequate records for risk analysis; failure to exercise appropriate controls; failure to validate computer software; failure to establish validation procedures; manipulation and deletion of audit trails; and many more. The time has never been more critical to evaluate and ensure your organization has top-notch compliant procedures. NNIT has many years of experience with CSV as well as DI and will be exhibiting at this congress taking place in Washington D.C. The congress will focus on the below subjects. Computer Systems Validation Conduct a CSV Audit Enterprise-Wide and Develop a Master Plan Perform Risk Assessments on Complex Systems Understand Documentation Requirements for Validation Confirm Accurate Processing, Control and Reporting of Electronic Records Develop an Effective CSV Corrective Action and Preventive Action (CAPA) Program Audit and Validate Paper, Electronic and Hybrid Systems Streamline Processes with Innovative E-Validation Solutions Write IQ/OQ/PQ Procedures, User Requirements and Test Scripts for New Systems Learn Best Practices for Change and Configuration Management Qualify Cloud Infrastructures & Mobile Devices Understand How to Validate Excel™ Spreadsheets Data Integrity Compliance Develop, Implement and Maintain Data Integrity Protocols Enterprise-Wide Learn the Methodology and Techniques Used to Identify Inaccuracies Conduct an Audit Enterprise-Wide Ensure the Reliability and Completeness of Analytical Data Identify and Investigate Root Causes of Integrity Lapses Cybersecurity Risk Management Implementation and Continued Verification Perform a Risk Assessment for Deficiencies Understand Requirements and How to Handle Audit Trails Personnel in the Following Environments Should Attend Validation QA/QC Engineering IT Quality Control Manufacturing Management Laboratory Management Regulatory Affairs