Validation of computer systems is essential to confirm their accuracy, reliability,consistent performance as intended, and the capability to identify invalid or modified records.This process is a fundamental requirement for compliance with electronic record standards. Our team of computer system validation specialists conducts validations for various sectors,including pharmaceutical and biologics manufacturers, medical device producers,clinical research organizations, and GLP laboratories. Regulatory bodies mandate the computer system validation (CSV) process to guarantee the accuracy and integrity of data within computerized systems, as well as to ensure product safety and efficacy. CSV should be performed when configuring a new system or when making updates to an existing validated system, such as upgrades, patches, or extensions. CSV processes must adhere to established regulations and guidelines. Best practices relevant to the field and the specific attributes of the system are subject to approval.
Dedicated CSV Service Line
Industry SMEs guide Program Success
Our SMEs continuously oversee proceedings
Effective Governance meets desired objectives
Skill Management across Client Locations
Planning & People Management across Locations
Minimal intervention from Client CSV Team
Reduced TCO in the long run
Business Continuity with flexibility for quick Ramp-up/down
Our CSV services include:
Requirement Analysis: We work with you to define clear and precise user and system requirements.
Risk Management: We conduct thorough risk assessments to identify and mitigate potential risks.
Validation Planning: A detailed validation plan is created to outline the scope and strategy.
System Testing: We perform comprehensive testing procedures to ensure the system meets requirements.
COMPUTER SYSTEM VALIDATION
Upgradtion Of Legacy System
Automation Support
PLC and SCADA Validation as per GAMP Requirements
Application Software Validation as per GAMP and EUANX 11 and CFR Part 11
EMS/BMS Quatlification
Audit Trail Review Assessment
Periodic Review Assessments
ERES Assessments
GAP Assessments for ALL type Computerized System
System Testing
System Testing: We perform comprehensive testing procedures, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), to ensure the system meets all functional and regulatory requirements.
Documentation: All steps of the validation process are meticulously documented, providing a clear audit trail and evidence of compliance.
