New GxP systems & automation
Establish intended use, GxP impact, validation strategy, requirements, supplier evidence and risk-based test scope before release.
SERVICE 06
Computerized System Validation & Digital Quality Consulting
Pune-based computerized system validation and digital-quality consulting with remote support worldwide, covering GxP systems, risk, traceability, data integrity and lifecycle governance.
Quality by design · Evidence by practice
WHEN CLIENTS ENGAGE US
Digital-quality support when system risk must become controlled evidence.
Engagements may begin with a new GxP system, automation project, legacy-system remediation, data-integrity concern or lifecycle review where validation evidence and control need strengthening.
Legacy CSV remediation
Reconstruct lifecycle evidence, assess gaps and prioritise remediation where validation packages are incomplete, inconsistent or outdated.
Data integrity & audit-trail concerns
Review access, roles, electronic records, audit trails, review practices and procedural controls supporting reliable GxP data.
Migration, upgrades & periodic review
Assess lifecycle changes, migration risk, backup/restore evidence and continued validated state before or after significant system change.
WHAT WE CAN SUPPORT
Digital quality built around intended use, risk and data integrity.
Support is tailored to your site, system, product context, risk profile and internal quality procedures.
Computerized-system assurance should be proportionate to intended use and GxP risk. Validation effort needs to focus on functions that can affect patient safety, product quality, data integrity and the reliability of regulated records.
We support lifecycle governance from system inventory and requirements through supplier evidence, testing, access and audit-trail controls, migration, release and periodic review.
Computerized System Inventory & GxP Impact Assessment
Risk-based system inventory and GxP impact assessment to determine validation, data-integrity and lifecycle controls.
Validation Planning
Validation strategy and planning based on intended use, system risk, supplier evidence and applicable requirements.
User Requirements & Traceability
Risk-focused user requirements and end-to-end traceability from intended use through testing and release evidence.
Supplier Assessment
Supplier and service-provider assessment covering quality systems, SDLC, support, security and relevant compliance evidence.
Risk Assessment
Documented assessment focused on patient safety, product quality, data integrity and intended use.
Test-Script & Evidence Review
Review of test design, expected results, deviations and objective evidence for adequacy and traceability.
Access & Audit-Trail Control Review
Review of user roles, privileged access, segregation, audit-trail configuration and review expectations.
Data Migration & Backup/Restore Test Planning
Risk-based planning for migration verification, backup/restore testing, reconciliation and supporting evidence.
Periodic Review
Periodic review of validated state, changes, incidents, access, audit trails, performance and supplier status.
GAMP 5 / Part 11 / Annex 11 Alignment
Assessment and validation approach aligned, as applicable, with GAMP 5, FDA 21 CFR Part 11 and EU GMP Annex 11.
DIGITAL VALIDATION LIFECYCLE
From intended use to continued validated state.
Digital validation is strongest when requirements, risk, supplier evidence, testing and operational controls remain connected throughout the system lifecycle.
Define intended use
Establish business purpose, users, records, interfaces, process context and functions that support regulated activity.
Assess GxP impact
Determine whether the system can affect patient safety, product quality, data integrity or regulated records and decisions.
Risk & criticality
Focus assurance effort on critical functions, failure scenarios, controls and data with the greatest GxP significance.
Requirements & traceability
Define risk-focused user requirements and connect critical requirements to specifications, controls and verification evidence.
Supplier & design evidence
Assess supplier capability and determine which existing development, configuration and test evidence can be leveraged appropriately.
Test & challenge
Verify critical functions and controls using proportionate testing, objective evidence, deviation management and traceable results.
Release & operate
Confirm validation evidence, access controls, procedures, training, backup, support and residual actions before operational release.
Maintain & review
Preserve the validated state through change control, incident review, access governance, periodic review and supplier oversight.
DIGITAL QUALITY EVIDENCE
Assurance that is proportionate, traceable and lifecycle-controlled.
Deliverables are tailored to intended use, GxP impact, system complexity, supplier capability, client procedures and applicable regulatory requirements.
CSV & digital-quality documentation
- Computerized-system inventory and GxP impact assessment
- Validation strategy and validation plans
- User Requirements Specifications and traceability matrices
- Supplier assessment and evidence review
- Risk assessments and test strategies
- Test-script and objective-evidence review
- Access and audit-trail control assessments
- Data migration and backup/restore test planning
- Periodic-review documentation
Risk-based computerized-system assurance
- GAMP 5 risk-based lifecycle principles
- FDA 21 CFR Part 11, where applicable
- EU GMP Annex 11 — Computerised Systems
- ICH Q9(R1) — Quality Risk Management
- Applicable data-integrity / ALCOA+ principles
- Client SDLC, validation and information-governance procedures
A defendable validated digital state
A computerized system whose intended use is defined, critical risks are understood, requirements and testing are traceable, regulated data is appropriately controlled and lifecycle decisions remain documented.
Use
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Risk
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Assure
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Maintain
PROJECT QUESTIONS
Planning a CSV or digital-quality review.
Which systems can be considered for a scoped CSV review?
Start with the system’s intended use, GxP impact, configuration, interfaces, supplier support and lifecycle stage. Suitability for an engagement is assessed against the system and the evidence available, rather than assumed from a software name alone.
Can validation support be delivered remotely?
Planning, requirements, risk assessments, traceability, supplier evidence and test-document review can be supported remotely. System access, execution responsibilities, data protection and any site-dependent activities must be agreed with the client’s authorised teams.
What should we send before sharing system records?
Provide a high-level description of the system, business process, project stage, users and main concerns. Avoid sending credentials, production data or confidential records through the general enquiry form. Detailed evidence can follow after access and confidentiality arrangements are agreed.
Explore worldwide service coverageLET'S DISCUSS YOUR NEEDS
Discuss a project ↗Need support with Digital Quality & CSV?
Tell us your context and what outcome you need to achieve.