Computerized System Validation
We specialize in Computerized System Validation (CSV) and Quality Assurance (QA) support services to our global customers in the life-sciences industry.
Quality Assurance (QA) support throughout the entire CSV lifecycle (concept, validation/project, operation, retirement)
Change management, CAPA management, periodic reviews
Creation and optimization of our customer's Quality Management System (QMS)
Creation of Standard Operation Procedures (SOPs)
Our strengths and differentiators
Understand our customer's needs. Meet our customer's user and technical requirements. Achieve and maintain compliance with industry regulations.
IT, quality and business perspectives, to achieve the project's goals.
Extensive experience in global and local CSV projects in Switzerland and in the United States.
Pragmatic, coupled with an efficient mix of waterfall and agile project management concepts.
Why choose Vimachem as your CSV and QA support partner
in the United States and in Europe in the field of Quality Management and Computerized System Validation.
to creating value for our customers.
where our customers choose one or more of our services according to their priorities and needs.
to our customers.
Why choose Vimachem for MES implementation & integration?
Our MES implementation process follows a structured approach to ensure seamless integration with your existing systems while maintaining GAMP®5 compliance. With a modular, pharma-focused MES platform, we deliver a fast, scalable and future-ready solution.
System risk assessments (ISRA, FMEA, FRA)
Computerized System classifications
Collection of requirements and identification of specifications (URS, FS, DS CS)
Validation project planning and execution (VP, Test Cases, Test Report)
Traceability matrix and validation reports (TM, VR)
Examples of computerized systems we validate
Quality Management Systems
Laboratory Information Management Systems
Enterprise Resource Planning systems
Manufacturing Execution Systems
Electronic Laboratory Notebooks
Laboratory data acquisition software
Programmable Logic Controllers
Laboratory and manufacturing electronic systems
Our services are focused on three areas
'As-is' assessment of the validation status of the regulated company's computerized systems
Assessment of 'as-is' validation status of computerized systems and GAMP processes
Review of information security governance and supplier assessments
Identification of validation gaps and areas of improvement
Preparation for audits (prepare for success during inspections)
Preparation for CSV audits (internal and customer inspections, audits from authorities)
Optimization of CSV framework
SOP review and creation
Gap remediation (validation projects)
Proposal and execution of Validation Plan for computerized systems based on assessments and findings
Estimation of effort and register of deliverables
Creation of necessary validation documentation and execution of validation project per V-model methodology and GAMP5 guidelines
