Our GxP Systems Validation Expertise for Establishing Global Regulatory Compliance
The successful implementation of a GxP system requires a comprehensive understanding of the system requirements, global regulations, validation knowledge and the expertise to facilitate stakeholder collaboration in alignment to the organization’s business goals. 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 Help Our Clients
In today's rapid technology-driven digital transformation, we help Pharma and Life Sciences companies to:
We have a dedicated team of specialized resources with validation and functional domain expertise to plan, execute and deliver audit-ready validation documentation.
Services We Offer
For over 12+ 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.
Strategic Validation Consulting
- Pharma Regulations Applicability Determination across Systems & Processes
- Prepare a comprehensive Compliance Roadmap that aligns to your Digital Transformation initiatives
- Supporting system selection and conducting Independent Supplier Audits on behalf of sponsors
Standalone CSV Project Services
- Planning and Execution of Computer Systems Validation (New Implementation & Upgrades)
- Cross-Functional System Integrations Validation (API-based, File based, Folder based)
- Systems and Data Migration Qualification (On-premise to Cloud or Cloud to Cloud)
- GxP Compliance Assessment and Remediation (Gap Analysis & Resolution Path)
- GxP Systems Decommissioning, Data Transfers & Process Transitioning
If your organization is seeking an experienced validation service partner who can take care of all your computer systems validation needs, we can extend our VaaS offering which includes the following:
- GxP Validation Lifecycle Management for all systems used across the Organization
- Validation Resource Augmentation for your ongoing change management needs
- Validation Program & Project Management Services to oversee and report project outcomes
- Continous support for all application upgrades and system migration as per your QMS policies & procedures
Compliance Assurance Services
If you are evaluating a software provider or if your planning to streamline your validation activities and elevate your compliance excellence, our team can help with the following activities:
- Help you to digitalize your end-to-end validation activities on an E-Validation Platform
- Support your team to complete the right e-validation platform selection, implementation & rollout
- Conduct Compliance Health Checks and Gap Assessment to get you ready for both internal and agency audits
- Provide Knowledge Support for establishing IT & Data Governance to realize maximum ROI with 100% compliance
- Establish Compliance Oversight Processes within your Organization to stay proactive and informed on compliance risks
With over 12+ years of pharma industry experience, we have strong capabilities to support ongoing change management of GxP critical process management systems, data platforms and related applications. Based on your validation needs, we have different service models to deliver high quality deliverables using industry best practices and ready-to-use validation accelerators.
Our Validation Framework
- Provide Inputs to Cross-Functional Teams for Business Process Design
- Offer Ready-to-Use Validation Kits prepared using GAMP-5 Principles
- Provide Accountability for 21 CFR Part 11, EU Annex 11, GDPR, HIPAA compliance
- Deliver audit-ready validation deliverables for the target GxP system
- Provide hands-on application training to End-users and System Administrators
- Orchestrate phased Global Solution Rollout with a centralized Deployment Plan
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
Our Pharma domain experts have worked extensively on a wide-range of enterprise applications used for managing GxP business processes and associated data. This includes software systems used for collecting and managing clinical trial data from pre-clinical to post-marketing of medicinal products.
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
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.
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.
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.
We can establish a 100% paperless e-validation process in your organization with the following services:
- E-Validation Platform Selection
- Validation Platform Implementation & Rollout
- Hosting & Support Services
- 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