Computer Systems Validation / Assurance

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Techsol’s GxP Systems Validation Expertise for achieving Quality, Efficiency and Regulatory Compliance

For over 10 years, Techsol has specialized in offering GxP Systems Validation services for many global Biopharmaceutical organizations and Contract Research Organizations (CROs). Using the GAMP 5 risk-based validation framework, our domain vertical experts have extensive experience in validating COTS (Commercially Off The Shelf) applications and custom developed application/ platforms to  account for GxP, FDA 21 CFR Part 11 and EU Annex 11 regulatory compliance requirements.

IPSE Gamp Techsol

Our Capability and Experience

  • Readily available validation accelerators based on best practices
  • Strong pharmaceutical domain and systems knowledge
  • Vast talent pool of technical and functional SMEs
  • Comprehensive Validation Policies and Procedures
  • 200+ Total GxP System Validation Projects
  • 100+ Systems Integration Validation Projects
  • 150+ Cloud System Validation Projects
  • 100+ Drug Safety System Validation Projects
  • 50+ Clinical System Validation Projects
  • 50+ Agency e-Submission Gateway Validation Projects

How We Can Help

One of the key success factors to execute a successful system validation is to qualify suppliers and leverage their competence to meet and exceed quality and compliance requirements.

  • We have conducted several supplier qualification assessments on behalf of our clients to determine business fit, potential risks, and identify compliance pitfalls.
  • Our supplier qualification protocols are defined based on best-practices to deliver accurate information about the target supplier.

With our domain expertise across the drug development lifecycle, we have a strong technical and functional team to execute independent GxP system validation activities for different types of GxP systems.

We have helped clients successfully implement and validate a wide-range of GxP applications which were hosted on-premise, partner data centers and third-party cloud vendor locations.

With our technical domain expertise, our validation SMEs have prepared and executed comprehensive validation activities to verify data exchange security, performance reliability, and volume scalability for API-based and file-based cross-functional GxP related system integrations.

Our approach to deliver successful results is based on our rigorous risk-assessment and mitigation procedures to identify and resolve single point of failures, unexpected service interruption scenarios and unaccounted data loss.

With over 70+ systems and data migration project experience, we have practical knowledge and domain experts to help clients transition successfully from one system to another in a regulatory compliant manner. Our migration qualification methodology is comprehensive to account for data integrity and data security.

Both Pharma companies and Contract Research Organizations have leveraged our expertise to evaluate and prepare GxP compliance assessment reports as part of Quality and IT System Audits.  Our reports are valued for its comprehensive coverage to check against regulatory requirements that are mandatory to comply for assuring patient safety, data quality and data integrity.

Clients migrating from one system to another have leveraged our expertise to complete the formal system decommissioning process. Activities such as secure data transfer, integrations turn-off, system retirement, etc. are performed as part of this process to ensure smooth systems transition.

Techsol Regulatory Compliance

Our Expertise

Techsol has validated the following types of GxP systems: ​

  • Clinical Development Data Management Systems
    • Clinical Trial Management Systems
    • Electronic Data Capture
    • Clinical Data Management Systems
    • Dictionary Management systems
    • Phase 1 Clinic Automation Systems
    • Electronic Patient Reported Outcomes
    • IVRS/ IWRS and more
  • Pharmacovigilance and Safety Signal Systems
    • Drug safety database
    • Signal detection and management systems
  • E-Submission Gateway Systems such as e-submission gateway set-up and pilot test with agencies
    • FDA, EMEA, MHRA, Health Canada, Brazil etc.
  • Enterprise Quality Management Systems
  • Laboratory Systems such as LIMS, Electronic Lab Notebook etc.
  • Manufacturing Systems such as Trace and Track/ Serialization, ERP, Product Life Cycle Management etc.
  • Document Vault and Content Management Systems

How We Deliver

Our systems validation methodology is based on Risk based methods defined by GAMP (Good Automated Manufacturing Practice) version 5 best practices. Our typical validation deliverables include:

  • System Requirements Specification (URS, FRS, Non-Functional, Regulatory, Reporting, System Integrations, etc.)
  • GxP Criticality Assessment and Compliance Assurance Needs Assessment (FDA 21 CFR Part 11, EU Annex 11, HIPAA, GDPR, etc.)
  • Validation Risk Management
  • System Architecture Design
  • Validation Master Plan
  • IQ, OQ, PQ/UAT Test Script Authoring, dry run and finalization. Test Execution and Report development
  • Support business users on execution of PQ/ UAT test scripts
  • Traceability Matrix development
  • Validation Summary Report

Optionally, we also help customers on authoring and assisting on developing business process SOPs. Based on GAMP 5 hardware and software categories, we generate the relevant validation documents for both COTS and custom-built, cloud and on-premise solutions.

Computer Software Assurance

As per FDA’s forthcoming guidance announcement, the new Computer Software Assurance (CSA) process is primarily focused on identifying intended use of the medical device or software system, checking its impact on patient / product safety and quality, identifying related risks, applying critical thinking and assurance needs, then finally execute testing and generate assurance documentation.


Computer Systems Software Assurance

Click here to read about our thought leadership on the adoption of computer software assurance.

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