Overview

Freyr’s entrepreneurial work culture is utmost flexible and attentive to the client-specific needs. It’s proven compliance experience and specialization in Regulatory, and cutting-edge technology can establish centralized cost-effective high-quality end-to-end compliance proposition for an organization’s quality assurance.

Freyr aims to set up a framework for implementing the quality system (GxP) that can be tailored to fit the specific environment, considering factors such as scope of operations, complexity of processes, and appropriate use of finite resources, as per 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 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