Join our talk ??Case study: Successful Implementation of AI in GMP environment" - at the Computer Systems Validations & Software Assurance University Conference on December 10-12, 2024 in Arlington, VA #computersystemvalidation #csv #computersoftwareassurance #csa #regulatorycompliance #regulatoryaffairs #qualitycontrol #artificialintelligence #machinelearning #AI #ML #GxP #Kenx #zifo #gmp
Zifo Compliance Solutions
IT 服务与咨询
US, UK, Germany, Japan, France，India, China, Swiss, Canada 1,834 位关注者
关于我们
Translating global regulatory dynamics into pragmatic solutions. Computer System Validation (CSV) | Computer Software Assurance (CSA) | Agile Methodology Validation | Data Integrity | Instrument Qualification | Automated Testing | Medical Device Validation | Regulatory Affairs | Scientific Application Quality Testing
- 网站
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https://www.zifornd.com/compliance-solutions.html
Zifo Compliance Solutions的外部链接
- 所属行业
- IT 服务与咨询
- 规模
- 501-1,000 人
- 总部
- US, UK, Germany, Japan, France，India, China, Swiss, Canada
- 创立
- 2008
动态
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Join us for an exciting webinar ?Unleashing the Power of AI: Practical Applications in Computer System Compliance. ???????? ???? ????????????????: https://lnkd.in/g6Zrh4C5 #computersystemvalidation #csv #computersoftwareassurance #regulatorycompliance #regulatoryaffairs #validation #qualitycontrol #artificialintelligence #machinelearning #AI #ML #GxP
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The European Medicines Agency (EMA) has updated its reflection paper on AI in drug development, incorporating feedback from 66 stakeholders and aligning with the recent EU AI Act. Key updates include harmonized technical terms, expanded glossary, and clarified scope to include shallow machine learning. The paper emphasizes the need for trustworthiness in AI technology throughout the medicinal product lifecycle. Click the link below to know more. https://lnkd.in/e4jUpUrT #EMA #ai #ml #dataintegrity #globalcompliance #regulationupdates #aiinmedicine #aiinhealthcare #benefitriskassessment #pharmaceuticals #riskassessment #riskandcompliance #dataintegrity #qualitymanagement #qualitycontrol #validation #qualityassurance #csv #regulatoryaffairs #regulatoryintelligence
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Great turnout at our presentations by Loganathan Kumarasamy, and Vivekram Apparsundaram at GMP University this week! Our sincere gratitude to KENX for providing us the opportunity to discuss these engaging topics. #csv #csa #zifo #kenx #computersystemvalidation #computersoftwareassurance #validation #regulatorycompliance #regulatoryaffairs #artificialintelligence #machinelearning #aiinhealthcare #changecontrol #gmp #cgmp
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The FDA has finalized guidance to help sponsors and clinical investigators comply with electronic records regulations under 21 CFR Part 11. This guidance clarifies the applicability of Part 11 to real-world data and updates recommendations for data integrity and security controls. It includes 29 Q&As on electronic records, systems, and digital health technologies. Click the link below to know more. https://lnkd.in/dXJvx8NC #FDA #ClinicalTrials #ElectronicRecords #DataIntegrity #DataSecurity #RealWorldData #DigitalHealth #ClinicalResearch #RegulatoryCompliance #MedicalDevices #CSV #validation #CSA
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Attending GMP University? Join our talk on ?? "???????????????? ?? ?????????????? ?????????????? ?????? ?????? ???? ????/???? ???? ?????? ??????????????????????" presented by Loganathan Kumarasamy, we hope to see you there! ???????? ???? ????????????????: https://lnkd.in/dYXhw7a7 #computersystemvalidation #csv #computersoftwareassurance #regulatorycompliance #regulatoryaffairs #qualitycontrol #artificialintelligence #machinelearning #AI #ML #GxP #Kenx #zifo #gmp
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Great turnout at our presentation by Loganathan Kumarasamy, at the ISPE Annual Expo in Orlando on the topic ‘???? ???? ???????? ?????????????????????????? ??????????????????.' Our sincere gratitude to ISPE for providing us the opportunity to present this engaging topic. #computersystemvalidation #csv #computersoftwareassurance #regulatorycompliance #regulatoryaffairs #validation #qualitycontrol #artificialintelligence #machinelearning #AI #ML #GxP #GmP #cGmP #IPSE #gmp #zifo
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We are thrilled to announce that Loganathan Kumarasamy, Head of Validation & Compliance Services at Zifo, will be a speaker at the ISPE Annual Meeting & Expo in Kissimmee, Florida. He will deliver an informative session on "???????????????????? ???????????????????????? ???? ???????? ?????????????????????????? ??????????????????" on October 14th. We hope to see you there! ???????? ???? ????????????????: https://lnkd.in/gvud6AHH #computersystemvalidation #csv #computersoftwareassurance #regulatorycompliance #regulatoryaffairs #validation #qualitycontrol #artificialintelligence #machinelearning #AI #ML #GxP #IPSE #gmp
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GMP University is just around the corner!? Join our talk on ?? “Effective Use of Change Control Methodologies for Lean Documentation,” presented by Vivekram Apparsundaram. Don’t forget to stop by our table to meet the Zifo Team. Link to register: https://lnkd.in/gPFAd5CP #changecontrol #leandocumentation #computersystemvalidation #csv #computersoftwareassurance #regulatorycompliance #regulatoryaffairs #validation #qualitycontrol #artificialintelligence #GxP #Kenx #zifo
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By adopting lean and cohort validation approaches, organizations can enhance the efficiency and effectiveness of analytical instrument validation. Focusing on equivalence assessment, leveraging existing documents, and reducing redundancy ensures compliance while optimizing resources. This can lead to significant cost savings, with an estimated 30-35% reduction in validation-related expenses. Zifo's expertise helps highly regulated organizations implement these strategies for streamlined processes and improved operational efficiency. Click the link below to know more. https://lnkd.in/gt4A74P7 #analyticalinstrumentvalidation #dataintegrity #globalcompliance #benefitriskassessment #pharmaceuticals #riskassessment #riskandcompliance #qualitymanagement #qualitycontrol #validation #qualityassurance #csv #regulatoryaffairs #regulatoryintelligence #instrumentvalidation #validationapproaches
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