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Regulatory Compliances Services
Overview |
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Kevin has emerged as a pioneer in providing the regulatory compliance services for last 6 years.
We offer Validation services for the following:
• Lab Equipments
• BMS Systems.
• PLC / SCADA /DCS Systems.
• ERP / SAP / LIMS / DMS / Clinical Database Systems.
Through Regulatory compliance services we help our clients assess and define their compliance and validation requirements.
Kevin Technologies offers specialized assistance involving consultation or validation services for a single system, a unit operation or an entire facility.
Our range of services encompasses the entire product life cycle and includes GAMP compliance services, validation services and projects requiring the integration of both these services.
Kevin boasts wealth of experience and exhaustive knowledge in the pharmaceutical industry, involving functioning of plants, details about regulatory requirements and more.
The company provides its client-specific assistance in the development and / or review of functional requirements, system design review, requests for proposals, system specifications, development of standard operating procedures and vendor evaluations: including process utilities, process equipment/systems, related process control/monitoring systems and development of re-qualification programs.
Kevin is dedicated towards devising and implementing a strategy that will lower the cost of development and support validated applications. This includes the development of 21 CFR part 11 compliant applications.
The ability to report application changes easily and to make comparisons in order to reduce validation and maintenance costs are and will be available in most of our systems enabling existing applications to be continued going forward and permitting enhancements to be made to applications with reduced effort for achieving forward and permitting enhancements to be made to applications with reduced effort for achieving 21 CFR part 11 compliance.
Kevin also has in-depth understanding and experience in providing CSV solutions meeting global regulatory requirements and can be customized to individual customer needs.
Kevin specializes in Master Validation Plan Development for Computer Systems, Control System Validation, Process Validation, Protocol Generation, Protocol Execution, SAT / FAT, IQ, OQ, PQ, Equipment Qualification, SOP Development. Kevin offers GAP and Risk Analysis for all Computerized Systems.
Kevin has provided Validation services to all major pharmaceutical companies in India for different applications.
What we can do for you
• GAP & Risk Analysis for all Computerized Systems.
• Validation of Systems as per GAMP requirements.
• Computer System Validation (CSV)
• Consult you on purchasing of system that are validated & develop systems that are easier to
re-validated & maintain.
• Help you in general for compliance to 21 CFR Part 11 requirements. |
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