IKCON PHARMA provides Computer System Validation (CSV) services to ensure that each Information Technology application fulfils its intended purpose. We provide guidance to the quality requirements in FDA/EMEA regulated industries that need specific controls and procedures throughout the Software Development Life Cycle (SDLC). Our Computer Systems Validation (CSV) team can establish the procedures and controls which have to be followed to validate a computer system for compliant with global regulatory requirements.
Computer systems are used to create, modify, maintain electronic records and to manage electronic signatures are also subject to the validation requirements. Computer systems must be validated to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records. FDA considers software validation to be “confirmation by examination and provision of objective evidence that software specifications conform to user needs and intended uses, and that the particular requirements implemented through software can be consistently fulfilled”.We provide the following services in implementing the software applications:
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GxP Assessment
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Vendor Assessment
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Risk Assessment
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21 CFR Part 11 Assessment
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Validation Master Plan
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Validation Plan
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System Requirement Specifications (SRS)
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System Design Specifications (SDS)
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System Configuration Specifications (SCS)
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Installation Qualification (IQ)
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Operational Qualification (OQ)
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Performance Qualification (PQ)
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Requirements Traceability Matrix (RTMX)
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Validation Summary Report (VSR)