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Delivering Comprehensive GxP System Validation and Compliance Assurance Across BioPharma and MedTech

In today's rapid technology-driven digital transformation, Pharma and Life Sciences companies face numerous challenges with GxP Computer Systems Validation. Determining an appropriate validation strategy, having the right resources, streamlining validation test execution and gaining comprehensive quality, risk and compliance oversight have been some of the key drivers for organizations to seek out promising alternatives to establish and demonstrate audit ready regulatory compliance.

Being a highly regulated industry sponsors find it cumbersome to generate and maintain complex validation documentation and related evidence. As most validation processes are manual and paper-based, the outcomes usually have compliance deficiencies, higher cost, and more significant opportunity for errors.

How We Can Help

Techsol provides a highly specialized and comprehensive validation-as-a-service (VaaS) offering to eliminate compliance risks and reduce the risk-burden with ongoing change management of GxP critical process management systems, data platforms and related applications. With a dedicated focus on Quality, Risk, Patient Safety and Regulatory Compliance, our validation-as-a-service is aimed towards delivering value by providing:

Techsol Regulatory Compliance

Strategic Planning for Validation Lifecycle Management

  • GxP Compliance Needs Assessment
  • Define Validation & Compliance Assurance Goals & KPI Measures
  • System Analysis for identifying Qualitative & Quantitative Validation Needs

Validation Resource & Service Delivery Management

  • SMEs Capacity Planning & Resource Augmentation
  • Resource Enablement on Client’s Processes, Policies & Procedures

Intelligent eValidation Platform

  • Electronic authoring, review, and approval of validation documents
  • Configuration of business rules and workflows to track validation progress
  • Auto-generated traceability and detailed documentation with evidence gathering

Project & Stakeholder Management

  • Stakeholder engagement and coordination
  • End-to-End Activities Management (Agile, Waterfall & Hybrid)
  • Validation Work Breakdown Structure Preparation
  • Resource budget allocation, tracking, and reporting
  • Project Communication, Issue Handling & Escalation
  • Project Status Reporting

Business Meeting
Techsol Background

Ongoing GxP Systems Validation Support

  • Technical / Regulatory Issues Resolution
  • Continuous Validation Continuous Deployment (CVCD) for ongoing IT changes

Quality, Risk & Compliance Oversight

  • Tracking of incidents, defects, policy violations, open CAPAs, etc.
  • Continuous monitoring of ongoing system changes
  • Audit readiness assessment
  • Identifying opportunities for continuous improvement

Our Capabilities

Our GxP Validation Accelerator enables sponsors to digitize manual error prone validation execution and stay audit ready at anytime. It facilitates real-time collaboration and provides instant visibility on critical quality and compliance risks. Listed below are some of the key benefits and value-gains that organizations can realize through our comprehensive validation offering.

  • Includes strategic planning and alignment to meet quality and compliance goals at various levels within the enterprise
  • Enables the visibility of validation tasks and provides management up-to-date information to monitor and control to improve the processes
  • Enable consistency by implementing standardization which improves company’s overall compliance posture
  • Automate review and approval of various workflows turning cycles from weeks and days into minutes and seconds
  • Electronic execution of validation protocols and automatic development traceability matrix eliminates the arduous task of manually handwriting test steps and expedite processes
  • Standardization of templates drives consistency, which improves compliance, and offers reusability
  • The task of scanning and copying documentation is eliminated
  • Turnkey (software + resources + processes) or project scope driven solutions
  • Customizable and flexible project delivery models
  • Experience with most of the paperless validation software platforms such as ValGenesis, ETQ eValidator etc.

Over the last 10+ years, Techsol has enabled several global biopharma and medical device companies to strategize, plan, and execute rapid GxP system implementation with comprehensive quality and compliance assurance. Our team of validation SMEs have extensive domain expertise and in-depth knowledge on global and regional GxP regulations such as FDA’s 21 CFR Part 11, EMA, ICH-GCP, GDPR, HIPAA, etc.

We have enabled our clients to launch their GxP operational systems faster using our proprietary validation accelerator which is engineered based on industry best-practices such as the GAMP-5 risk-based approach, ITIL, and Total Quality Management frameworks.

Our GxP validation accelerator has been used by clients across the following areas:

  • Clinical Systems Validation
  • Drug Safety Platform Validation
  • Equipment and Instrument Validation
  • Lab Validation
  • Process Validation
  • Data Analytics Validation
  • Medical Device Qualification and Assurance
  • Automation Validation

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