Computer System Validation

Digital Services

Ensure Compliance with Syntel’s Risk-Based CSV Approach

Increasing scrutiny by regulatory bodies and emphasis on product safety and effectiveness is putting pressure on life sciences companies to cost effectively reduce compliance and product recall risk. Syntel’s CSV solutions help our clients ensure that their GxP systems operate with peak quality and efficiency to meet quality and regulatory requirements, while minimizing risk and legal costs.

Our experienced consultants have real-world experience in laboratory, pre-clinical, clinical, drug safety and regulatory areas, plus a powerful set of CSV templates, processes and procedures, tools, and reusable assets to reduce your CSV timelines.

Offerings

We offer an end-to-end suite of Computer System Validation services, from planning to execution and documentation of IQ, OQ, PQ and all other validation deliverables that meet GAMP 5 standards.  Our services include:

  • Analysis and System Remediation
    • Meets US FDA 21 CFR Part 11, EU Annex 11, PMDA ERES guidelines for 100% regulatory compliance
  • Process Consulting
    • CSV Process Harmonization and Optimization
    • Regulatory Compliance
    • Standard Operating Procedures (SOPs)
    • Templates, Checklists and Training
  • GxP Risk Assessment and Control Mitigation
    • ICH GLP / GCP / GMP Risk Assessments
    • Implementation of control requirements
  • Validation Testing Services
    • Unit Testing
    • Integration Testing
    • System Testing
    • User Acceptance Testing
    • Continuous Testing
  • CSV Audits
  • CSV Hands-on Services
  • IT Infrastructure Management

Offerings

The Syntel Advantage

  • Integrated solution for continuous process improvement, quality assurance and compliance
  • G-Agile Framework: Automation-driven Agile project management tools and methodologies for improved speed and first-time-right
  • Quality, Risk & Compliance: Defined SOPs, stringent QC procedures, robust risk management and effective governance models to ensure high quality, minimal risk and better compliance
  • Test Automation: Multi-level test automation powered by the SyntBots automation platform
  • Robust suite of tools and accelerators: Includes validation templates, SOPs, estimation and project management dashboards, document template generator, document routing tool and others

Success Stories

Helping a Client Meet 21CFR11 Regulations and Guidelines

The client is a global medical device, pharmaceutical and biotech company. They were facing increased litigation due to regulatory submissions that did not adhere with FDA 21CFR11 regulations and guidelines. They clearly needed help ensuring that their applications were compliant in GxP regulated areas, so they turned to Syntel based on our life sciences expertise as well as our robust, risk-based computer system validation (CSV) methodology.

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