--- title: 博客 | 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. 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. --- [![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/cn/) - [主页](https://www2.pqegroup.com/cn/) - [行业](https://www2.pqegroup.com/cn/industry/) - [药品 & 活性成分](https://www2.pqegroup.com/cn/pharma-api/) - [医疗器械](https://www2.pqegroup.com/cn/medical-device/) - [生物技术](https://www2.pqegroup.com/cn/biotech/) - [初创企业](https://www2.pqegroup.com/cn/startup/) - [兽药](https://www2.pqegroup.com/cn/veterinary/) - [我们的服务](https://www2.pqegroup.com/cn/services/) - [数据完整性](https://www2.pqegroup.com/cn/data-integrity/) - [数字化管理](https://www2.pqegroup.com/cn/digital-governance/) - [工程](https://www2.pqegroup.com/cn/engineering/) - [调试、确认和验证 (CQV)](https://www2.pqegroup.com/cn/commissioning-qualification-validation/) - [质量合规](https://www2.pqegroup.com/cn/quality-compliance/) - [卓越实验室](https://www2.pqegroup.com/cn/laboratory-excellence/) - [药政事务](https://www2.pqegroup.com/cn/regulatory-affairs/) - [审计](https://www2.pqegroup.com/cn/audits/) - [临床研究](https://www2.pqegroup.com/cn/clinical-research/) - [培训](https://www2.pqegroup.com/cn/training/) - 关于 - [关于我们](https://www2.pqegroup.com/cn/about/) - [企业社会责任](https://www2.pqegroup.com/cn/about/csr/) - 资源中心 - [新闻 & 新闻稿件](https://www2.pqegroup.com/cn/news/) - [网络研讨会](https://www2.pqegroup.com/cn/webinars/) - [博客](https://blog.pqegroup.com/zh-cn) - [加入我们](https://www2.pqegroup.com/cn/careers/) - [联系我们](https://www2.pqegroup.com/cn/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. [主页](https://www2.pqegroup.com/cn/) [博客](https://blog.pqegroup.com/) # **最新文章** [计算机化系统验证和数据完整性 ![](https://blog.pqegroup.com/hubfs/banner%20insghits-Regulatory%20Trends%20in%20Computer%20Systems%20Validation%20and%20Data%20Integrity_1.jpg)](https://blog.pqegroup.com/zh-cn/csv-data-integrity/csv-regulatory-trends-during-covid19) 14 2月 2023 ## [计算机化系统验证和数据完整性的监管趋势：全球大流行期间差距分析、远程审计、检查准备和补救措施的演变 Covid-19 大流行给制药行业带来的最明显的变化体现在监管部门的审计方法以及生产商对其供应商的审计中。“远程审计“的思路开始萌生，并且现在已经被成功实践。](https://blog.pqegroup.com/zh-cn/csv-data-integrity/csv-regulatory-trends-during-covid19) [![twitter](https://blog.pqegroup.com/hubfs/twitter-1.png)](https://twitter.com/intent/tweet?text=计算机化系统验证和数据完整性的监管趋势：全球大流行期间差距分析、远程审计、检查准备和补救措施的演变&url=https://blog.pqegroup.com/zh-cn/csv-data-integrity/csv-regulatory-trends-during-covid19) ### 分类 - [GxP合规 (4)](https://blog.pqegroup.com/zh-cn/tag/gxp合规) - [医疗器械 (1)](https://blog.pqegroup.com/zh-cn/tag/医疗器械) - [女性科技(FemTech) (6)](https://blog.pqegroup.com/zh-cn/tag/女性科技femtech) - [工程 (1)](https://blog.pqegroup.com/zh-cn/tag/工程) - [药政事务 (1)](https://blog.pqegroup.com/zh-cn/tag/药政事务) - [计算机化系统验证和数据完整性 (5)](https://blog.pqegroup.com/zh-cn/tag/计算机化系统验证和数据完整性) - [调试、确认和验证 (CQV) (1)](https://blog.pqegroup.com/zh-cn/tag/调试-确认和验证-cqv) - [附录一 (4)](https://blog.pqegroup.com/zh-cn/tag/附录一) 查看所有话题 ### 注目記事Top 5 ### [领英](https://www.linkedin.com/company/pqe-group/) ![PQE Group](https://blog.pqegroup.com/hubfs/logo%20PQE%20Group%20+%20payoff-BLUE.svg) 自1998年起，PQE就通过了ISO 9001质量体系认证。 扫描关注PQE微信公众号。 ![PQE Group wechat weixin](https://blog.pqegroup.com/hs-fs/hubfs/PQE%20Group%20wechat%20weixin.jpg?width=127&height=127&name=PQE%20Group%20wechat%20weixin.jpg)   - 探索 - [加入PQE](https://www2.pqegroup.com/cn/careers/) - [全球分支](https://www2.pqegroup.com/cn/contact-us/#locations) - [关于](https://www2.pqegroup.com/cn/about/) - [博客](https://blog.pqegroup.com/zh-cn) - 相关链接 - [隐私政策](https://www2.pqegroup.com/privacy-notice/) - [Cookie政策](https://www2.pqegroup.com/cookie-policy/) - [组织模式](https://www2.pqegroup.com/cn/model-of-organization/) - [道德守则](https://www2.pqegroup.com/ethical-code/) English - [简体中文](https://blog.pqegroup.com/zh-cn/author/gaurav-walia) - [English](https://blog.pqegroup.com/author/gaurav-walia) - [Español - España](https://blog.pqegroup.com/es-es/author/gaurav-walia) - [Español - México](https://blog.pqegroup.com/es-mx/author/gaurav-walia) - [Français](https://blog.pqegroup.com/fr/author/gaurav-walia) - [Polski](https://blog.pqegroup.com/pl/author/gaurav-walia) - [Português - Brasil](https://blog.pqegroup.com/pt-br/author/gaurav-walia) - [日本語](https://blog.pqegroup.com/ja/author/gaurav-walia) 切换语言 Copyright 2023 | 上海彼科意企业管理咨询有限公司 [LinkedIn](https://www.linkedin.com/company/pqe-group) [![twitter](https://blog.pqegroup.com/hubfs/twitter-w.png) Twitter](https://twitter.com/PQEGroup) [Facebook](https://www.facebook.com/PQEGroup/) [Instagram](https://www.instagram.com/lifeatpqe) [YouTube](https://www.youtube.com/c/PQEGroup) [Xing](https://www.xing.com/pages/pqegroup)