At Mivigilance, we provide expert and unbiased assessments that are balanced, which help ensure that strengths are recognized, and weaknesses are addressed. Our team provides both strategic recommendations and frontline tactical support through services including programmatic support, validation/qualification operations, and computer system validation.
In addition to providing standard IT system testing as part of our tactical services portfolio, our experts also provide a hands-on approach to validation documentation, validation activities, and evaluation. program price. Our team is also very experienced in managing the ongoing validation process and has worked halfway with the on-site teams to provide expert input.
Mivigilance experts have repeatedly accepted the challenges of participating in validation projects that need to be rescued. Our experts review all work that has been done as planned and establish a baseline, initiate incremental improvements and contribute any additional aspects as needed. This approach is always helpful for clients to achieve their compliance and operational goals smoothly.
The authentication experience includes device authentication in a lab environment, device authentication in a production environment, and software validation in all GxP domains. Mivigilance CSV experts have comprehensive domain experience to help you create internal validation workflows and enhance team collaboration. We have helped organizations put in place the following processes:
- Change control
- Change Management
- Configuration management
- Electronic signature (certification and policy)
- IT security procedures
- IT Risk Assessments processes
- IT Infrastructure Framework documents
- Retrospective validation
- Patch Managements
- Periodic reviews
- Electronic data integrity assessments
- Our experts guide compliance with key regulations such as 21 CFR Part 1
- EU annex 11 and any local regulations that may apply.
Computer Science/ IT Audit Offering:
- Advice on CSV strategies and requirements
- Statistics and programming in GxP related systems
- Process Audits (SDLC or parts of SDLC and IT support processes
- Software suppliers
- CSV documentation reviews
- SDLC Design and Implementation
- Computer System Validation (CSV) Audits (Specific system/software or group of systems)
- CSV Vendor Audits (computer systems supplied by third parties e.g., eCRFs, eTMFs, IRT)
- Gap Analyses vs key CSC requirements e.g., 21 CFR 11
- Electronic records/signatures