What an incredible year 2024 has been! From achieving new milestones to overcoming challenges, significant progress has been made together. Here's a quick summary of all our achievements in 2024— Take a moment to explore them: https://lnkd.in/gDG-PppC Cheers to the unforgettable moments of 2024 and to an exciting new journey in 2025! #2024highlights #teamwork #gratitude #success #complianceg #milestones #lookingahead
Compliance Group Inc
Software Development
Libertyville, IL 18,198 followers
FDA Consortium Member and the Leading Provider of Validation & Quality Compliance Solutions
About us
Compliance Group is a Quality Compliance solutions provider based in Illinois, US with offices in NJ, the UK and India. Compliance Group’s motto is to provide “right-sized” compliance solutions. Compliance Group is the only service provider organization in FDA consortium. This FDA & Industry consortium is coming up with a paradigm shift in validation guidance for the industry. This knowledge & expertise has resulted in significant capital and operational savings for our clients. Compliance Group is also a Siemens Solution Partner in ALM space. With automation at the center of it's services, onsite/near-shore/offshore service delivery models, and presence in US/EU & India, Compliance Group has proven expertise supporting customers with the following: - Quality Data Analytics compatible to FDA Quality Metrics program - Hands-free Process Validation, Training, Design Transfer and DHF Support documentation using "Smart Glasses" - On-Premise or SaaS Quality System offerings - Setting up QMS and SQA policies - Center of Excellence (CoE) - Setting up and running CoE models using Onsite/Offshore delivery models - Support with Computer System Validation, Process Validation, Equipment Validation, Cleaning Validation, Medical Device product validation & Quality Engineering (CAPAs, NCRs, Complaints, Supplier Quality execution) - Audit/Inspection Readiness Assessments – If there is an impending Internal Audit or an External Regulatory Agency Inspection, we can perform Audit Readiness Assessments and deliver prioritized remediation activities - Supplier Quality Audits – Our certified Auditors can perform Supplier Quality audits and provide intelligence on Supplier Quality. - Remediation Packages – Packages to address Consent Decrees, 483s, Warning Letters and Data Integrity Issues - Process Improvement Packages - Serialization/UDI - Setup & end to end line validation/compliance
- Website
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https://www.complianceg.com
External link for Compliance Group Inc
- Industry
- Software Development
- Company size
- 201-500 employees
- Headquarters
- Libertyville, IL
- Type
- Privately Held
- Founded
- 2007
- Specialties
- Quality, Compliance, FDA Consortium, Audit & Inspection Remediation, SaaS and On-Premise Quality System implementations, Clinical Trial Development Support, Biostatistics, Data Analytics & Statistical Programming , Process Validation, Computer System Validation, Medical Device Validation, Cleaning Validation, 483, Consent Decree, Warning Letter Remediation, Audit Readiness Assessments, Data Integrity Assessment & Remediation, Serialization/UDI, Supplier Quality Audits, QMS Policies & Procedure Setup, Managed Services, Polarion, Siemens, FDA, and FDA Quality Metrics
Locations
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Primary
Get directions
1512 Atraius Parkway
Libertyville, IL 60048, US
Employees at Compliance Group Inc
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Rick Dursch
Director Data Integrity & Software Validation
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Laura McDevitt
Senior Quality Assurance Specialist | Lead Trainer for CSA/CSV
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Jonathan Meuzelaar
Healthcare / life sciences leader with over 20 years experience, responsible for product and customer success, leveraging industry expertise to…
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James Higgins
Senior Growth Marketing Manager
Updates
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#FDA Wednesday: How can real-world data transform healthcare? The FDA’s Center for Drug Evaluation and Research (CDER) has announced the Center for Real-World Evidence and Innovation a groundbreaking initiative to leverage real-world data in improving drug development, safety monitoring, and public health outcomes. By integrating advanced #datainsights into #regulatoryscience, the FDA is paving the path for better #decisionmaking, more effective treatments, and a brighter future for #patientcare. Through collaboration with cutting-edge technology, real-world data insights, Compliance Group Inc. plays a vital role in streamlining decision-making, enabling faster and more efficient delivery of safe and effective medical products to the market. Learn more about this transformative initiative: https://lnkd.in/gKcFBEUd Visit us at https://lnkd.in/gXZQ-cHc Please send your questions to info@complianceg.com #fda #realworldevidence #drugsafety #healthcare #innovation #lifesciences #fdawednesday #cder #insights #medicaldevices
CDER establishes center for real-world evidence innovation
fda.gov
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#CSA_Tuesday: Future of CSV/CSA in FDA 21 CFR Part 11 compliance is filled with exciting possibilities. As technology continues to advance, and regulations evolve, keeping pace with the latest trends, innovations, and best practices becomes paramount for maintaining compliance. At Compliance Group Inc, we offer unparalleled expertise in conducting in-depth and comprehensive inspections of systems and procedures. Our vast experience allows us to ensure seamless compliance with the requirements of #21CFRPart11, tailored to unique company needs. Explore our blog here to gain valuable insights and take necessary steps towards optimizing your compliance strategies: https://lnkd.in/gc-83NgT Visit us at https://lnkd.in/gXZQ-cHc Please send your questions to info@complianceg.com #csa #csv #21cfrpart11 #software #application #fdacsa #safety #compliance #latesttrends #innovation #csatuesday #fdacompliance #softwarevalidation #complianceg
FDA 21 CFR Part 11 Compliance | Trends | Innovations | Best Practices
https://www.complianceg.com
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Immerse yourself in the dynamic landscape of regulatory excellence and witness firsthand how we redefine compliance standards. From cutting-edge solutions to our passionate team, this video is a visual feast of what sets Compliance Group Inc apart. Witness the power of collaboration as we push boundaries and create solutions that make a real impact. From cutting-edge technologies to our dynamic team culture, this video is a celebration of everything that makes CG exceptional. Visit us at https://lnkd.in/gXZQ-cHc Please send your questions to info@complianceg.com #compliancegroup #complianceg #regulatory #regulatoryexcellence #fda #fdaregulations #compliance #lifescience
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Compliance Monday’s: Emerging Standards and Regulations for Medical Devices Are you prepared for the evolving standards and regulations in the medical device industry? As the #MedTech landscape advances, staying compliant with new global regulations is essential for ensuring safety, performance, and innovation. This article delves into the latest updates shaping the industry and offers insights into how medical device organizations can adapt to meet these changes. From updated global standards to emerging regulatory frameworks, gain valuable knowledge to navigate this dynamic environment effectively. Compliance Group Inc’s tailored solutions simplify the path to compliance and operational success amid changing standards. Explore the article here: https://lnkd.in/g_GDaw2X Visit us at https://lnkd.in/gXZQ-cHc Please send your questions to info@complianceg.com #compliancemondays #medtech #fda #healthcare #innovation #medicaldevices #complianceg #compliance
Emerging Standards and Regulations for Medical Devices - In Compliance Magazine
https://incompliancemag.com
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Compliance Group Inc Group was excited to participate in key sessions at CSV & CSA University AI Implementation & Validation organized by KENX! It was a great opportunity to engage with industry leaders and share insights on AI in CSV & CSA. Check out the event highlights and explore the moments captured in the images below #complianceg #compliancegroup #kenx #csa #csv #validationuniversity #ai #artificialintelligence
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#Polarion_Friday: In the highly regulated world of medical device development, managing design control processes is critical for ensuring compliance with industry standards and regulatory requirements. Polarion’s features help organizations efficiently manage design processes, ensuring audit readiness with clear documentation and compliance tracking. By streamlining documentation, Polarion supports compliance, simplifies audits, and reduces the risk of non-compliance. Visit us at https://lnkd.in/gXZQ-cHc Please send your questions to info@complianceg.com #polarion #alm #polarionalm #complianceg #polarionfriday #compliance #regulatory
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#OCM_Thursday: Aligning technology with business objectives and cultivating a culture of agility and adaptability within the workforce are keys to reducing setbacks. By proactively identifying and addressing potential challenges, and continuously monitoring progress through feedback, organizations can stay up to date and manage changes effectively. This approach fosters smooth transitions, leading to successful digital transformation. Please send your questions at- info@complianceg.com Visit us at - https://lnkd.in/gXZQ-cHc #ocmthursday #changemanagement #ocm #complianceg #lifesciences
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#FDA Wednesday – Are you up to date with the FDA’s guidance on CGMP for production and process controls? The FDA has released a Q&A to clarify critical aspects of #CGMP regulations, offering insights to enhance compliance and product quality. Key highlights include: • Guidance on defining and monitoring process parameters. • Best practices for implementing robust process controls. • Tips to ensure consistent product quality and safety. Stay ahead in pharmaceutical manufacturing by aligning with these updated CGMP standards. At Compliance Group Inc, we specialize in supporting manufacturers with cGMP compliance, ensuring the highest quality standards and robust regulatory adherence in #drugmanufacturing. Explore the guidance here to strengthen your compliance framework: https://lnkd.in/gXZz4KQn Visit us at https://lnkd.in/gXZQ-cHc Please send your questions to info@complianceg.com #fda #regulatory #cgmp #pharma #compliance #manufacturing #complianceg #fdawednesday #draftguidance
Questions and Answers on Current Good Manufacturing Practice
fda.gov
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#CSA_Tuesday: Implementing Agile in #CSA environment comes with distinct challenges such as balancing documentation with Agile minimalism, ensuring validation readiness in iterative development, redefining the "definition of done," enhancing cross-team collaboration, and maintaining quality while ensuring speed delivery. Discover strategies to overcome these hurdles and achieve seamless Agile-CSA integration. Watch this byte video for actionable insights and practical solutions to streamline your Agile practices while meeting CSA requirements and achieve seamless Agile-CSA integration! Visit us at https://lnkd.in/gXZQ-cHc Please send your questions at info@complianceg.com #csa #agilecsa #complianceg #softwareassurance #compliance #validation #softwarevalidation #agile #implementation #digitaltransformation https://lnkd.in/gKQzknS7