--- title: blog | Dr Eva Kelly description: Eva holds a degree in Analytical Science and a PhD in Chemistry from Dublin City University, bringing over 25 years of experience in site solutions and learning management across various sectors, including pharmaceuticals, medical devices, and FMCG. She has specialized as a Data Integrity SME, with expertise in 21 CFR Part 11 and Annex 11 compliance, and has led Data Integrity and QA IT roles within pharma and biotech companies, focusing on GxP SAAS, hosted, and on-premise solutions. Eva is passionate about fostering a culture of Data Integrity (DI) excellence, working directly with clients to implement DI governance strategies that prioritize people, processes, and technology. Over the past decade, she has honed her skills in stakeholder presentations, quality risk management, and the implementation of systems such as SABA Cloud, EtQ Reliance, VEEVA Vault, and Axway Track and Trace, among others. With a deep understanding of DI's evolving role, Eva is dedicated to helping clients achieve thorough GxP record compliance and successful DI initiatives. --- [![ERA Sciences - evolved data integrity solutions](https://go.erasciences.com/hubfs/Logo%20horizontal%20transparency%20black-1.svg "ERA Sciences - evolved data integrity solutions")](http://erasciences.com) Search toggle - [Home](https://erasciences.com) - [Success stories](https://erasciences.com/success-stories) - [Resources](https://go.erasciences.com/blog) Resources - [Articles](https://go.erasciences.com/blog) - [Events](https://go.erasciences.com/blog/tag/events) - [About us](https://erasciences.com/about-us) - [Contact us](https://erasciences.com/contact-us) [![ERA Sciences - evolved data integrity solutions](https://go.erasciences.com/hubfs/Logo%20horizontal%20transparency%20black-1.svg "ERA Sciences - evolved data integrity solutions")](http://erasciences.com) - [Home](https://erasciences.com) - [Success stories](https://erasciences.com/success-stories) - [Resources](https://go.erasciences.com/blog) Resources - [Articles](https://go.erasciences.com/blog) - [Events](https://go.erasciences.com/blog/tag/events) - [About us](https://erasciences.com/about-us) - [Contact us](https://erasciences.com/contact-us) Search toggle [![ERA Sciences - evolved data integrity solutions](https://go.erasciences.com/hubfs/Logo%20horizontal%20transparency%20black-1.svg "ERA Sciences - evolved data integrity solutions")](http://erasciences.com) - [Home](https://erasciences.com) - [Success stories](https://erasciences.com/success-stories) - [Resources](https://go.erasciences.com/blog) Resources - [Articles](https://go.erasciences.com/blog) - [Events](https://go.erasciences.com/blog/tag/events) - [About us](https://erasciences.com/about-us) - [Contact us](https://erasciences.com/contact-us) Search toggle What are you looking for? Search ![Dr Eva Kelly](https://go.erasciences.com/hs-fs/hubfs/Dr%20Eva%20Kelly.webp?width=120&name=Dr%20Eva%20Kelly.webp) # Dr Eva Kelly Eva holds a degree in Analytical Science and a PhD in Chemistry from Dublin City University, bringing over 25 years of experience in site solutions and learning management across various sectors, including pharmaceuticals, medical devices, and FMCG. She has specialized as a Data Integrity SME, with expertise in 21 CFR Part 11 and Annex 11 compliance, and has led Data Integrity and QA IT roles within pharma and biotech companies, focusing on GxP SAAS, hosted, and on-premise solutions. Eva is passionate about fostering a culture of Data Integrity (DI) excellence, working directly with clients to implement DI governance strategies that prioritize people, processes, and technology. Over the past decade, she has honed her skills in stakeholder presentations, quality risk management, and the implementation of systems such as SABA Cloud, EtQ Reliance, VEEVA Vault, and Axway Track and Trace, among others. With a deep understanding of DI's evolving role, Eva is dedicated to helping clients achieve thorough GxP record compliance and successful DI initiatives. [eva.kelly@erasciences.com](mailto:eva.kelly@erasciences.com) [Follow me on LinkedIn](https://www.linkedin.com/in/dr-eva-kelly) [![](https://go.erasciences.com/hubfs/DALL%C2%B7E%202025-01-15%2019.59.48%20-%20A%20ligne%20claire%20style%20illustration%20depicting%20a%20celebratory%20scene%20for%20the%202024%20annual%20review%20of%20ALCOA+%20data%20integrity%20in%20the%20life%20sciences%20industry.%20T-1.webp)](https://go.erasciences.com/blog/topdataintegrityauditissues2024) [![](https://go.erasciences.com/hubfs/DALL%C2%B7E%202025-01-15%2019.59.48%20-%20A%20ligne%20claire%20style%20illustration%20depicting%20a%20celebratory%20scene%20for%20the%202024%20annual%20review%20of%20ALCOA+%20data%20integrity%20in%20the%20life%20sciences%20industry.%20T-1.webp)](https://go.erasciences.com/blog/topdataintegrityauditissues2024) ## [2024 Top Data Integrity Audit Issues](https://go.erasciences.com/blog/topdataintegrityauditissues2024) 16 Jan 2025 [Dr Eva Kelly](https://go.erasciences.com/blog/author/dr-eva-kelly) In the fast-evolving world of life sciences, ensuring the integrity of GMP records has never been... [Read More](https://go.erasciences.com/blog/topdataintegrityauditissues2024) [Data Integrity](https://go.erasciences.com/blog/tag/data-integrity), [Data backup and restore](https://go.erasciences.com/blog/tag/data-backup-and-restore), [21 CFR Part 11](https://go.erasciences.com/blog/tag/21-cfr-part-11), [Digital transformation](https://go.erasciences.com/blog/tag/digital-transformation), [Data Integrity Audits](https://go.erasciences.com/blog/tag/data-integrity-audits), [gmp](https://go.erasciences.com/blog/tag/gmp), [Life Sciences](https://go.erasciences.com/blog/tag/life-sciences) [![](https://go.erasciences.com/hubfs/Life_Science_Fusion_Logo_Hi%20Res%20(1).png)](https://go.erasciences.com/blog/collaboration-lifescience) [![](https://go.erasciences.com/hubfs/Life_Science_Fusion_Logo_Hi%20Res%20(1).png)](https://go.erasciences.com/blog/collaboration-lifescience) ## [Collaboration: The New Frontier of Life Sciences Innovation](https://go.erasciences.com/blog/collaboration-lifescience) 17 Dec 2024 [Dr Eva Kelly](https://go.erasciences.com/blog/author/dr-eva-kelly) In an era of rapid technological advancement, life sciences companies face unprecedented challenges... [Read More](https://go.erasciences.com/blog/collaboration-lifescience) [High reliability](https://go.erasciences.com/blog/tag/high-reliability), [ICH Q10](https://go.erasciences.com/blog/tag/ich-q10), [Risk assessment](https://go.erasciences.com/blog/tag/risk-assessment), [Collaboration](https://go.erasciences.com/blog/tag/collaboration), [21 CFR Part 11](https://go.erasciences.com/blog/tag/21-cfr-part-11), [Digital transformation](https://go.erasciences.com/blog/tag/digital-transformation), [gmp](https://go.erasciences.com/blog/tag/gmp), [Life Sciences](https://go.erasciences.com/blog/tag/life-sciences) [![](https://go.erasciences.com/hubfs/Top%2010%20Data%20Integrity%20Requests%20During%20a%20Life%20Sciences%20Audit.png)](https://go.erasciences.com/blog/top-10-data-integrity-requests-during-a-life-sciences-audit) [![](https://go.erasciences.com/hubfs/Top%2010%20Data%20Integrity%20Requests%20During%20a%20Life%20Sciences%20Audit.png)](https://go.erasciences.com/blog/top-10-data-integrity-requests-during-a-life-sciences-audit) ## [Top 10 Data Integrity Requests During a Life Sciences Audit](https://go.erasciences.com/blog/top-10-data-integrity-requests-during-a-life-sciences-audit) 23 Nov 2024 [Dr Eva Kelly](https://go.erasciences.com/blog/author/dr-eva-kelly) In today’s life sciences industry, ensuring data integrity is crucial to maintaining regulatory... [Read More](https://go.erasciences.com/blog/top-10-data-integrity-requests-during-a-life-sciences-audit) [High reliability](https://go.erasciences.com/blog/tag/high-reliability), [Data Integrity](https://go.erasciences.com/blog/tag/data-integrity), [21 CFR Part 11](https://go.erasciences.com/blog/tag/21-cfr-part-11), [Annex 11](https://go.erasciences.com/blog/tag/annex-11), [GAMP5](https://go.erasciences.com/blog/tag/gamp5), [ALCOA Plus](https://go.erasciences.com/blog/tag/alcoa-plus), [Computerized Systems Inventory List](https://go.erasciences.com/blog/tag/computerized-systems-inventory-list), [Phanero](https://go.erasciences.com/blog/tag/phanero), [Data Integrity Audits](https://go.erasciences.com/blog/tag/data-integrity-audits) [![](https://go.erasciences.com/hubfs/EnhancingDigitalCompliance_FoReSight_CSA_v0_2.pptx.svg)](https://go.erasciences.com/blog/post/data-integrity-everyone-s-responsibility-0) [![](https://go.erasciences.com/hubfs/EnhancingDigitalCompliance_FoReSight_CSA_v0_2.pptx.svg)](https://go.erasciences.com/blog/post/data-integrity-everyone-s-responsibility-0) ## [Data Integrity: Ensuring Consistency Amidst Technological Advancement](https://go.erasciences.com/blog/post/data-integrity-everyone-s-responsibility-0) 13 Nov 2024 [Dr Eva Kelly](https://go.erasciences.com/blog/author/dr-eva-kelly) Back in June 2021, we emphasized that data integrity is a shared responsibility. The article... [Read More](https://go.erasciences.com/blog/post/data-integrity-everyone-s-responsibility-0) [ICH Q10](https://go.erasciences.com/blog/tag/ich-q10), [Resilience](https://go.erasciences.com/blog/tag/resilience), [Stakeholder engagement](https://go.erasciences.com/blog/tag/stakeholder-engagement), [Data Integrity](https://go.erasciences.com/blog/tag/data-integrity), [Data integrity culture](https://go.erasciences.com/blog/tag/data-integrity-culture) [![ALCOA+ an image that describes the attributes of data with integrity](https://go.erasciences.com/hubfs/Imported_Blog_Media/aa5f63_b68596df8fa34b54a9a0bd4e5403c9d6~mv2.png)](https://go.erasciences.com/blog/post/data-integrity-to-infinity-and-beyond-starting-2023) [![ALCOA+ an image that describes the attributes of data with integrity](https://go.erasciences.com/hubfs/Imported_Blog_Media/aa5f63_b68596df8fa34b54a9a0bd4e5403c9d6~mv2.png)](https://go.erasciences.com/blog/post/data-integrity-to-infinity-and-beyond-starting-2023) ## [Data Integrity - To Infinity and Beyond, starting 2023!](https://go.erasciences.com/blog/post/data-integrity-to-infinity-and-beyond-starting-2023) 4 Jan 2023 [Dr Eva Kelly](https://go.erasciences.com/blog/author/dr-eva-kelly) Having just welcomed 2023 and watched way too many animated movies (including a household... [Read More](https://go.erasciences.com/blog/post/data-integrity-to-infinity-and-beyond-starting-2023) [Data Integrity](https://go.erasciences.com/blog/tag/data-integrity) [![Pandemic tracing as an example of data integrity](https://go.erasciences.com/hubfs/Imported_Blog_Media/aa5f63_71cbaead328c4edc98122cdf1dbf5d4a~mv2.png)](https://go.erasciences.com/blog/post/original-gxp-record-the-o-in-alcoa) [![Pandemic tracing as an example of data integrity](https://go.erasciences.com/hubfs/Imported_Blog_Media/aa5f63_71cbaead328c4edc98122cdf1dbf5d4a~mv2.png)](https://go.erasciences.com/blog/post/original-gxp-record-the-o-in-alcoa) ## [Original GxP Record, The O in ALCOA+](https://go.erasciences.com/blog/post/original-gxp-record-the-o-in-alcoa) 4 Nov 2021 [Dr Eva Kelly](https://go.erasciences.com/blog/author/dr-eva-kelly)  Understanding what constitutes an original record and applying data management... [Read More](https://go.erasciences.com/blog/post/original-gxp-record-the-o-in-alcoa) [Data Integrity](https://go.erasciences.com/blog/tag/data-integrity), [True copies](https://go.erasciences.com/blog/tag/true-copies) [![](https://go.erasciences.com/hubfs/Imported_Blog_Media/aa5f63_aa7f01b52ed74cb99b0bf1a0c2247629~mv2.png)](https://go.erasciences.com/blog/post/the-art-of-exception) [![](https://go.erasciences.com/hubfs/Imported_Blog_Media/aa5f63_aa7f01b52ed74cb99b0bf1a0c2247629~mv2.png)](https://go.erasciences.com/blog/post/the-art-of-exception) ## [The Art of 'Exception'](https://go.erasciences.com/blog/post/the-art-of-exception) 26 Aug 2021 [Dr Eva Kelly](https://go.erasciences.com/blog/author/dr-eva-kelly) When ERA Sciences advise on test exception management for protocol execution issues,... [Read More](https://go.erasciences.com/blog/post/the-art-of-exception) [Test exceptions](https://go.erasciences.com/blog/tag/test-exceptions) [![A cartoon of pandora's box](https://go.erasciences.com/hubfs/Imported_Blog_Media/aa5f63_540eaeb0732a4119b842f71ecc17c123~mv2.jpg)](https://go.erasciences.com/blog/post/is-data-backup-restore-still-a-pandora-s-box-for-your-organisation-part-1) [![A cartoon of pandora's box](https://go.erasciences.com/hubfs/Imported_Blog_Media/aa5f63_540eaeb0732a4119b842f71ecc17c123~mv2.jpg)](https://go.erasciences.com/blog/post/is-data-backup-restore-still-a-pandora-s-box-for-your-organisation-part-1) ## [Is Data Backup/Restore still a Pandora's Box for your organisation? Part 1](https://go.erasciences.com/blog/post/is-data-backup-restore-still-a-pandora-s-box-for-your-organisation-part-1) 26 Aug 2021 [Dr Eva Kelly](https://go.erasciences.com/blog/author/dr-eva-kelly) [Read More](https://go.erasciences.com/blog/post/is-data-backup-restore-still-a-pandora-s-box-for-your-organisation-part-1) [Data Integrity](https://go.erasciences.com/blog/tag/data-integrity), [Data backup and restore](https://go.erasciences.com/blog/tag/data-backup-and-restore) [![Picture of post it note images](https://go.erasciences.com/hubfs/Imported_Blog_Media/aa5f63_1fd48b41cdef4556882dc1c79af7e73f~mv2.png)](https://go.erasciences.com/blog/post/data-flow-maps-no-pain-no-gain) [![Picture of post it note images](https://go.erasciences.com/hubfs/Imported_Blog_Media/aa5f63_1fd48b41cdef4556882dc1c79af7e73f~mv2.png)](https://go.erasciences.com/blog/post/data-flow-maps-no-pain-no-gain) ## [Data Flow Maps - No pain No gain?](https://go.erasciences.com/blog/post/data-flow-maps-no-pain-no-gain) 5 Aug 2021 [Dr Eva Kelly](https://go.erasciences.com/blog/author/dr-eva-kelly) Depending on your industry sector, the applicable regulations and the type of data and... [Read More](https://go.erasciences.com/blog/post/data-flow-maps-no-pain-no-gain) [Data Integrity](https://go.erasciences.com/blog/tag/data-integrity), [Data flow maps](https://go.erasciences.com/blog/tag/data-flow-maps) [![An image of people collaborating with laptops](https://go.erasciences.com/hubfs/Imported_Blog_Media/aa5f63_76f29b2604a14508b4db9805aedd3446~mv2.png)](https://go.erasciences.com/blog/post/avoid-ping-pong-meetings-and-inefficient-decision-making) [![An image of people collaborating with laptops](https://go.erasciences.com/hubfs/Imported_Blog_Media/aa5f63_76f29b2604a14508b4db9805aedd3446~mv2.png)](https://go.erasciences.com/blog/post/avoid-ping-pong-meetings-and-inefficient-decision-making) ## [Avoid Ping pong meetings and inefficient decision making?](https://go.erasciences.com/blog/post/avoid-ping-pong-meetings-and-inefficient-decision-making) 26 Jul 2021 [Dr Eva Kelly](https://go.erasciences.com/blog/author/dr-eva-kelly) ## What holds up or derails our decision making process? How many times have we gone... [Read More](https://go.erasciences.com/blog/post/avoid-ping-pong-meetings-and-inefficient-decision-making) [Stakeholder engagement](https://go.erasciences.com/blog/tag/stakeholder-engagement), [Collaboration](https://go.erasciences.com/blog/tag/collaboration) [1](https://go.erasciences.com/blog) [2](https://go.erasciences.com/blog/author/dr-eva-kelly/page/2) ## Unlock your potential: Join our courses today! Ready to take the next step in your professional journey? Our expertly designed courses are here to empower you with the skills and knowledge needed to excel in your field. Don't just dream about success - make it a reality with us. Enroll today and start your path to greatness! 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