Regulatory, GxP, FDA | Quality Compliance Service
WEBCG helps life sciences companies make quality frictionless, while reimagining regulatory compliance. As industry thought leaders, we deliver the exact expertise, process and technology required for our customers to achieve sustained quality excellence across the value chain. Our customers are able to deliver higher quality products to market ...
Why Compliance Group | FDA Consultant Partners
WEBLed by noted industry thought leaders, we work with the FDA, ISPE GAMP and other industry partners to continuously champion quality best practices and drive regulatory change. CG has highly-skilled resources covering the gamut of required expertise that life sciences companies can access on demand. Built on leading best practices, CG’s ...
Our Team | Compliance Group Inc
WEBSarat specializes in building worldclass teams and enabling great customer experiences through agile services and creative solutions. His 20+ year career extends across tech entrepreneurship, building rockstar teams, program management, FDA regulated processes, business leadership and M & A. As the CEO of Compliance Group, Sarat …
Technology Assessment Services for Regulatory Compliance
WEBAt CG, we help organizations navigate the complex technology landscape with comprehensive assessments and tailored solutions. Our expert assessments are designed to optimize systems, and ensure compliance, laying a strong foundation for growth and innovation. From selecting the right technologies, such as low-code platforms and AI …
Supply Chain Quality Management | Compliance Group
WEBCG helps medical device and pharmaceutical manufacturers reduce supply chain and compliance risks and ensure consistent product quality through our comprehensive supplier auditing, monitoring and improvement programs. We leverage advanced data analytics and risk assessment tools to identify quality issues early, prevent costly recalls and ...
Unlocking Quality Excellence | Compliance Group Inc
WEBIn meeting with our customers on their journey to Quality Excellence, Compliance Group provides significant depth and breadth of experience. In an ideal scenario, we assess a customer’s “as-is” vs “to-be” skillsets, business process workflows, digital technology roadmaps, and organizational culture. From there, we can co-create and ...
FDA Computer Software Assurance |Computer System Validation …
WEBHaving a robust Computer System Validation (CSV) program compliant with 21 CFR Part 11 and Annex 11 is central to ensuring systems are working and are maintained in a state of compliance. CG is the thought leader in CSV/CSA, having co-created the FDA-Industry CSA team in 2016 which has evangelized CSA and helped shaped the recent FDA Draft ...
QMS For Life Sciences | Compliance Group Inc
WEBQUALITY MANAGEMENT SYSTEM OPTIMIZATION. CG focuses on 3 pillars of QMS: EFFECTIVENESS – We evaluate current systems and identify potential gaps, suggesting the tools and automation needed to enhance productivity and manage risk.. EFFICIENCY – We integrate systems to seamlessly automate current manual processes.. …
Business Process Consulting | Compliance Group Inc
WEBBUSINESS PROCESS CONSULTING. CG’s consulting engagements deliver solutions to bridge gapped business processes, ensuring a connected digital thread. We help customers “rethink” their current approaches, maximizing the adoption and value of digital tools. Let CG clarify regulatory complexity and misperceptions, and help you streamline your ...
Navigating Compliance Technology Challenges|Compliance Group
WEBCompliance Group recognizes that a holistic approach is mandatory. Given our deep regulatory compliance knowledge, industry thought leadership, collaboration with Regulators, and our technology and OCM expertise through the lens of validation, we bring a unique and significantly-differentiated perspective to assessing and minimizing friction ...
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