Overview Expertise Advantages Overview Freyr’s work culture is of utmost flexibility and is attentive to client-specific needs. Its proven quality compliance services experience and specialization in Regulatory and cutting-edge technology can establish a centralized, cost-effective, high-quality end-to-end audit and compliance services proposition for an organization’s quality assurance. Freyr aims to set up an audit and compliance framework for implementing the quality system (GxP compliance services) that can be tailored to fit the specific environment, considering the factors such as the scope of operations, the complexity of processes, and the appropriate use of finite resources, as per the client's SOPs, recommended standards, and guidelines. Freyr Expertise Compliance and Audit Services Place of Activities – Cost-effective Hybrid Managing Quality, Regulatory and Information Security at the organization level (process as well as QMS documents) Remote Ensuring compliance on applicable guidelines and legislations of USFDA, EU, MHLW, ICH-GCP, 21 CFR Part 11, PIC/S, GAMP 5, HIPAA; CSV standards; Data transfer content standards; ISO 27001; 9001 Standards Remote Standard Operating Procedure (SOP) preparation, review and change management Remote Training coordination and documentation Remote Hosting Audits: On-site customer audits, web audits, supporting Regulatory audits, certification audits, accreditation audits Remote: If < 6 Audits per year Near shore: 6-8 Audits per year On-premise: = /> 12 Audits per year Conducting Internal Audits for SDLC Compliance: Process audits, information security audits, documentation audits, SDLC audit, SDLC control audits, inspections, mock audits Remote/ On-premise Conducting Management Review Committee (MRC) meetings, minutes and follow-up Remote Supplier Audits: Audits on outsourcing (resource as well as process outsourcing) On-premise CAPA Management: CAPA plans, triage CARs and perform RCA. Alert senior management on non-compliance concerns that poses significant risk. Remote Software Validation (Computer System Validation) for Waterfall and Sprint SDLC Remote Maintaining awareness of updates in changing Regulatory landscape that impact GxP by establishing and maintaining relations with external agencies and bodies as relevant to business Remote Assist business development/sales by responding to RFIs and RFPs Remote Review customer feedback forms Remote Quantification of departmental deliverables and presentation of metrics to the management on a regular basis - Management System Metrics Dashboard Remote Drive/coordinate continual improvement programs Remote Freyr Advantages Science-based approaches Decisions based on the understanding of the intended use of a product Proper identification and control of areas of potential process weakness Responsive deviation and investigation systems that lead to timely remediation Sound methods for assessing and reducing risk Well-defined processes and products, starting from development and extending throughout the product lifecycle
