???How is GDocP essential to Data Integrity and Risk Mitigation? ???What are the regulatory requirements associated with GDocP? ???What does an application of good documentation practices look like? ???How can you customize GDocP solutions to meet your business goals? ???Discover the essentials to implementing GDocP for the Life Sciences #GDocP #dataintegrity #riskmitigation #lifesciences #fdacompliance
Arbour Group LLC
IT 系统测试与评估
Warrenville ，IL 1,778 位关注者
Cencora Regulatory Compliance Firm providing 21 CFR Part 11 & Annex 11 Validation and Verification for the Life Sciences
关于我们
Arbour Group LLC is a regulatory compliance firm that provides full-scope regulatory products and services for computer systems within pharmaceutical, medical device, and biotechnology companies worldwide. We address 21 CFR Part 11 and Annex 11 validation and verification testing requirements. Arbour Group offers pre-packaged validation solutions for major ERP systems. Our regulatory services reflect a results-oriented software testing process that assures compliance and functionality and responds competitively to customer needs to ensure product quality and patient safety.
- 网站
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https://www.arbourgroup.com
Arbour Group LLC的外部链接
- 所属行业
- IT 系统测试与评估
- 规模
- 超过 10,001 人
- 总部
- Warrenville ，IL
- 类型
- 上市公司
- 创立
- 1990
- 领域
- SAP Validation、Oracle Validation、Software Testing、Software Validation、Staff Augmentation、NetSuite Validation、Digital Compliance、Quality Assurance、Cloud Compliance、Infrastructure Qualification、MS Dynamics 365 Validation、21 CFR Part 11 Assessment & Compliance、GDPR、Annex 11 Assessment & Compliance、GxP Compliance、Life Sciences Validation、FDA Compliance、IT Policies and Procedures、IT Vendor Audit、Data Privacy & GDPR和Part 11 Validation & Verification
地点
Arbour Group LLC员工
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Ali Asgar Saherwala
Director C&V at Arbour Group LLC
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Danison Abraham
Senior Validation Consultant at Arbour Group LLC
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Mike Funk
Project / Validation Manager at Arbour Group LLC
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Alexander Patterson
CEO & Founder — Ravine Point Capital > Strategic & Scalable Growth Strategies > C-Level Executive with 25+ Years’ Business Development Experience
动态
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Hello, Microsoft Community Summit in San Antonio! Navigating Life Sciences regulatory requirements and complex cloud infrastructures? Meet with Alexander Noble to discuss how Arbour Group’s Software Validation and Cloud Services can ensure compliance: tinyurl.com/2bbofhcq #SummitNA #Microsoft #CommunitySummitNA #lifesciences #MySummitNA
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Attending Microsoft’s Community Summit in San Antonio? Connect with Alexander Noble to discuss how Life Science companies navigate complex regulatory requirements with Arbour Group’s Software Validation, Azure Cloud Infrastructure Qualification, and Managed Services. Schedule a time to review how Arbour Group can align with your business goals: tinyurl.com/2bbofhcq #SummitNA #Microsoft #CommunitySummitNA #lifesciences #MySummitNA
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??How does #AI powered #automation impact the traditional regulatory landscape? ??How are data integrity expectations of regulatory agencies affected? ??Arbour Group's Bioinformatics Quality and Compliance EVP Chris McNally will provide the keynote address for #UiPathFORWARD in Las Vegas on Oct 23rd.
Excited to announce that my good friend and esteemed colleague Chris McNally, Bioinformatics Quality and Compliance EVP for Arbour Group LLC, will provide the key note address to the #UiPathFORWARD #lifesciences industry session in Las Vegas on October 23rd. With over 30 years of professional experience, Chris leads a team specializing in the regulatory implications of digital processing and transfer of biologic modalities such as immunotherapies, antibody drug conjugates, Cas9 and peptide agonist therapies into commercialization at scale. Chris will provide his point of view on how #AI powered #automation is impacting the traditional regulatory landscape and data integrity expectations of regulatory agencies across a variety of #quality system strategies and processes.? Should be an insightful and inspiring session. James Prospero Jason Warrelmann Beth Politsch Jared Welch Jason B. Sam Reynolds Gregory Dikopf Neil Scott Derrick Miu Catherine Ferland Kelly Sears Brian Burnett Melissa Tumelty Bill Coey Jared Toye Robert Lord Kartik Sennerikuppam Chris Barry Paul Long
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??Why is Data Integrity essential to Bioinformatics compliance? ??How does Risk Management play a vital role? ??How is Data Acquisition and Analysis involved in Bioinformatics compliance? ??Arbour Group provides comprehensive services to ensure Bioinformatics Digital Compliance: https://lnkd.in/gjuzKAA2 #bioinformatics #bioinformaticsdigitalcompliance #digitalcompliance
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??What compliance challenges do open systems face? ??What are the compliance requirements of closed systems? ??What are examples of open and closed systems? ??Navigate 21 CFR Part 11 Compliance and know the difference between Open and Closed Systems with Arbour Group LLC. #opensystems #closedsystems #21cfrpart11 #21cfrpart11compliance #fdacompliance #lifesciences
Navigating 21 CFR Part 11: Open vs. Closed Systems
arbourgroup.com
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?How do you ensure regulatory compliance with analysis software packages like SoftMax Pro? ?What validation and data integrity activities are necessary for a compliant digital SMP environment? ?How do you transition analytical benchtop methods to SMP digital protocols? ?What is assay validity determination relative to acceptance criteria? ?How can Arbour Group further assist with: ??Curve fitting calculations ??SMP configuration ??Graphical data presentation ??Trending reporting tables ??AI model data set creation ??SDLC documentation ??Code reviews ??SOPs ??Formula enhancements ?Determine the right analysis software package with Arbour Group LLC. #softmaxpro #softwarecompliance #bioassays #smp
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?What are the 21 CFR Part 11 compliance standards? ?How do you prepare for CFR Part 11 compliance? ?Do you know what compliance pitfalls to avoid? ??Partner with Arbour Group to meet demanding compliance requirements and transform your regulatory landscape. #21cfrpart11 #21cfrpart11compliance #fda #fdacompliance #electronicrecords
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We're #hiring a new Pharmacovigilance Manager in Philippines. Apply today or share this post with your network.