Quality Compliance
REVIVE’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.
REVIVE 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.
Compliance and Audit Services | |
| 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 |