Quality and Compliance
Members of Karya's platform specialize in providing Quality & Compliance Services to assist burgeoning life science companies.
Our comprehensive array of services is designed to maintain and enhance quality, compliance, efficiency, and safety throughout a product's entire lifecycle. Leveraging the deep expertise of our Quality & Compliance members, we deliver unparalleled support by sharing best practices and insightful strategies for effective program and process management.
Computer System Validation
Karya's validation specialists, all independent consultant members within our platform, employ cutting-edge techniques to validate computer systems for regulatory compliance.
They bring extensive expertise from pharmaceuticals, biotech, and other industries to ensure clients' systems are inspection-ready.
Karya provides validation services for cloud-based applications and infrastructure, tailored to meet regulatory requirements.
Consultants within the platform possess expertise in various areas, including cloud-based applications (SaaS and PaaS), Configured Off-the-Shelf (COTS) applications, and both on-premises and cloud-based infrastructure (IaaS). They are skilled in performing validation processes for software updates, including initial, retrospective, and ongoing validation.
Additionally, our consultant members ensure compliance with FDA and EU regulations, offering guidance on Part 11 and Annex 11 compliance and data integrity.
Compliance
Karya's independent compliance consultants offer proactive solutions to mitigate risks and enhance compliance efforts.
They collaborate closely with clients to prepare for inspections, conduct audits, and implement corrective actions.
Quality Assurance & Investigations
Karya's experts specialize in quality investigations and CAPA support, helping clients address discrepancies and implement effective corrective actions.
They bring decades of experience in delivering investigation reports and facilitating continuous improvement.
Expert Guidance
Karya's network of independent QP consultants ensures compliant manufacturing and importation processes in EU and UK markets.
They assist clients in obtaining necessary authorizations and maintaining quality oversight throughout the supply chain.
Remediation and Optimization
Karya offers risk-based remediation services to help organizations achieve compliance and operational efficiency.
Experts support developing and optimizing quality management systems to meet regulatory expectations.
Project Management Solutions
Karya's Project Management services offer tailored support for various project needs, from clinical development to post-merger integration.
Independent consultants deliver expertise in program management, R&D process optimization, and technology transfer.
Innovative Solutions for Medical Devices
Karya supports medical device clients with regulatory navigation, quality system development, and program management.
Independent experts ensure compliance and facilitate efficient product development and commercialization processes.