--- title: Blog | Gaurav Walia description: "Sr. Global Director of Business Development and Principal Computer System Validation & DI Consultant @PQE Group - Over 24 years of experience in Pharma/MD and Consumer Healthcare environment with extensive experience in end to end processes such as CSV, Data Integrity, QMS, SDLC, Validation and Qualification, IT Policies and SOP generation, review, revision and approval, IT Infrastructure Review and Qualification/Validation and Audit/Documentation, overall Audit/Assessment Execution with GAP Generation and Remediation, Customer and Vendor Audit and Compliance Quality Assurance Compliance and Laboratory Analyses. \n\nMr. Walia has over 100 FDA Audits/Inspections under his belt as well as 3 Major Consent Decree Projects focusing on Computer Systems Validation and Data Integrity and is also former Director of R&D, Quality and IT CSV." --- [![Logo PQE Group - azzurro - 2024](https://blog.pqegroup.com/hs-fs/hubfs/Logo%20PQE%20Group%20-%20azzurro%20-%202024.png?width=2000&height=721&name=Logo%20PQE%20Group%20-%20azzurro%20-%202024.png "Logo PQE Group - azzurro - 2024")](https://www2.pqegroup.com) - [Home](https://www2.pqegroup.com/) - [Industry](https://www2.pqegroup.com/industry/) - [Pharma & API](https://www2.pqegroup.com/pharma-api/) - [Medical Device](https://www2.pqegroup.com/medical-device/) - [Biotech](https://www2.pqegroup.com/biotech/) - [Startup](https://www2.pqegroup.com/startup/) - [Veterinary](https://www2.pqegroup.com/veterinary/) - [Services](https://www2.pqegroup.com/services/) - [Data Integrity](https://www2.pqegroup.com/data-integrity/) - [Digital Governance](https://www2.pqegroup.com/digital-governance/) - [Engineering](https://www2.pqegroup.com/engineering/) - [Commissioning, Qualification and Validation (CQV)](https://www2.pqegroup.com/commissioning-qualification-validation/) - [Quality Compliance](https://www2.pqegroup.com/quality-compliance/) - [Laboratory Excellence](https://www2.pqegroup.com/laboratory-excellence/) - [Regulatory Affairs](https://www2.pqegroup.com/regulatory-affairs/) - [Audits](https://www2.pqegroup.com/audits/) - [Training](https://www2.pqegroup.com/training/) - [Clinical Research](https://www2.pqegroup.com/clinical-research-services/) - [Pharmacovigilance](https://www2.pqegroup.com/pharmacovigilance/) - About - [About Us](https://www2.pqegroup.com/about/) - [ESG](https://www2.pqegroup.com/about/csr/) - [Women in STEM](https://www2.pqegroup.com/about/women-in-stem/) - Resources - [News & Press](https://www2.pqegroup.com/news/) - [Webinars](https://www2.pqegroup.com/webinars/) - [Blog](https://blog.pqegroup.com/) - [Careers](https://www2.pqegroup.com/careers/) - [Contact Us](https://www2.pqegroup.com/contact-us/) # Gaurav Walia #### Sr. Global Director of Business Development and Principal Computer System Validation & DI Consultant @PQE Group - Over 24 years of experience in Pharma/MD and Consumer Healthcare environment with extensive experience in end to end processes such as CSV, Data Integrity, QMS, SDLC, Validation and Qualification, IT Policies and SOP generation, review, revision and approval, IT Infrastructure Review and Qualification/Validation and Audit/Documentation, overall Audit/Assessment Execution with GAP Generation and Remediation, Customer and Vendor Audit and Compliance Quality Assurance Compliance and Laboratory Analyses. Mr. Walia has over 100 FDA Audits/Inspections under his belt as well as 3 Major Consent Decree Projects focusing on Computer Systems Validation and Data Integrity and is also former Director of R&D, Quality and IT CSV. [Home](https://www2.pqegroup.com/) [Blog](https://blog.pqegroup.com/) # **Latest Insights** [GxP Compliance ![](https://blog.pqegroup.com/hubfs/Quality%20by%20Design%20Gaurav_Blog-1.webp)](https://blog.pqegroup.com/gxp-compliance/quality-by-design-in-an-era-of-advanced-technologies-in-life-sciences) 25 Nov 2025 ## [Quality by Design in an Era of Advanced Technologies in Life Sciences Quality by Design (QbD): building quality from the start with QTPP, CQAs, and CPPs—now powered by AI, ML, and Digital Twins to transform Life.](https://blog.pqegroup.com/gxp-compliance/quality-by-design-in-an-era-of-advanced-technologies-in-life-sciences) [![twitter](https://blog.pqegroup.com/hubfs/twitter-1.png)](https://twitter.com/intent/tweet?text=Quality%20by%20Design%20in%20an%20Era%20of%20Advanced%20Technologies%20in%20Life%20Sciences&url=https://blog.pqegroup.com/gxp-compliance/quality-by-design-in-an-era-of-advanced-technologies-in-life-sciences) [CSV & Data Integrity ![](https://blog.pqegroup.com/hubfs/CSA%20Gaurav_Blog%20banner%20interno.jpg)](https://blog.pqegroup.com/why-computer-software-assurance-csa-is-the-future-of-validation-in-life-sciences) 17 Jun 2025 ## [Why Computer Software Assurance (CSA) Is the Future of Validation in Life Sciences CSA: the future of validation in life sciences—smart, risk-based, and patient-focused](https://blog.pqegroup.com/why-computer-software-assurance-csa-is-the-future-of-validation-in-life-sciences) [![twitter](https://blog.pqegroup.com/hubfs/twitter-1.png)](https://twitter.com/intent/tweet?text=Why%20Computer%20Software%20Assurance%20(CSA)%20Is%20the%20Future%20of%20Validation%20in%20Life%20Sciences&url=https://blog.pqegroup.com/why-computer-software-assurance-csa-is-the-future-of-validation-in-life-sciences) [Quality by Design ![](https://blog.pqegroup.com/hubfs/Critical%20Thinking%20%26%20QbD_Site%20Banner_1-2.jpg)](https://blog.pqegroup.com/quality-by-design/connecting-two-novel-concepts-critical-thinking-quality-by-design) 09 Sep 2024 ## [Connecting Two Novel Concepts: Critical Thinking & Quality by Design Explore the synergy between Critical Thinking & Quality by Design in improving processes, reducing risks, and enhancing product quality.](https://blog.pqegroup.com/quality-by-design/connecting-two-novel-concepts-critical-thinking-quality-by-design) [![twitter](https://blog.pqegroup.com/hubfs/twitter-1.png)](https://twitter.com/intent/tweet?text=Connecting%20Two%20Novel%20Concepts:%20Critical%20Thinking%20&%20Quality%20by%20Design&url=https://blog.pqegroup.com/quality-by-design/connecting-two-novel-concepts-critical-thinking-quality-by-design) [Cybersecurity ![](https://blog.pqegroup.com/hubfs/AI-Powered%20Defenses%20for%20Cybersecurity_Site%20Banner.jpg)](https://blog.pqegroup.com/cybersecurity/ai-powered-defenses-for-cybersecurity-vulnerabilities-in-the-life-sciences-industries) 27 Oct 2023 ## [Guarding the Future: AI-Powered Defenses for Cybersecurity Vulnerabilities in the Life Sciences Industries As industries continually integrate with the virtual realm, the life sciences sector is becoming increasingly susceptible to cyber threats.](https://blog.pqegroup.com/cybersecurity/ai-powered-defenses-for-cybersecurity-vulnerabilities-in-the-life-sciences-industries) [![twitter](https://blog.pqegroup.com/hubfs/twitter-1.png)](https://twitter.com/intent/tweet?text=Guarding%20the%20Future:%20AI-Powered%20Defenses%20for%20Cybersecurity%20Vulnerabilities%20in%20the%20Life%20Sciences%20Industries&url=https://blog.pqegroup.com/cybersecurity/ai-powered-defenses-for-cybersecurity-vulnerabilities-in-the-life-sciences-industries) [CSV & Data Integrity ![](https://blog.pqegroup.com/hubfs/banner%20insghits-Regulatory%20Trends%20in%20Computer%20Systems%20Validation%20and%20Data%20Integrity_1.jpg)](https://blog.pqegroup.com/csv-data-integrity/csv-regulatory-trends-during-covid19) 29 Aug 2022 ## [Regulatory Trends in Computer Systems Validation and Data Integrity After Covid-19 Pandemic, with FDA almost set to start remote auditing, is your company inspection ready?](https://blog.pqegroup.com/csv-data-integrity/csv-regulatory-trends-during-covid19) [![twitter](https://blog.pqegroup.com/hubfs/twitter-1.png)](https://twitter.com/intent/tweet?text=Regulatory%20Trends%20in%20Computer%20Systems%20Validation%20and%20Data%20Integrity&url=https://blog.pqegroup.com/csv-data-integrity/csv-regulatory-trends-during-covid19) ### Categories - 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