In the highly regulated pharmaceutical industry, ensuring quality and accuracy of data is of utmost importance. The FDA therefore mandates Computer System Validation (CSV) as the “establishing of documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality attributes.” Good CSV practices help increase usability and reliability of the software, reduce possible errors and risks by finding issues before the software is used, and greatly minimize recalls caused by adverse effects on patients.

APSS- Futuristics offers end-to-end Computer Systems Validation and Regulatory Compliance Services to our clients to ensure system accuracy, reliability and consistent performance, while reducing compliance risk. Our CSV service offerings may be grouped under the following heads:

Strategic IT Compliance Consulting

• Implementation of risk based GAMP 5 CSV process model
• FDA 21 CFR Part 11 Inspection Readiness Consulting
• GxP System Inventory and Portfolio Analysis

IT Compliance

• Quality Coaching
• Compliance Reviews of CSV Deliverables/Quality gate reviews

CSV Hands on Services

• End to end CSV Validation Planning to Validation Summary
• Risk and Compliance Assessments
• Validation Project Management and Training