[{"data":1,"prerenderedAt":990},["ShallowReactive",2],{"$f-z_na1Vmc7UNoYARhodhP5zbWWkzF5n8_p5nfuQR3Jw":3,"localizations-enixj3ogedv9cvqkr1e9naia-en":350,"global-seo-setting":355,"header-setting":402,"footer":476,"navigations":597,"certificates":843,"localizations-pages-enixj3ogedv9cvqkr1e9naia-en":985},{"data":4,"meta":349},{"id":5,"title":6,"slug":7,"createdAt":8,"updatedAt":9,"publishedAt":10,"documentId":11,"locale":12,"showOnArticlesPage":13,"disablePrerender":13,"category":14,"tagCategory":22,"blogImage":22,"settings":22,"seo":23,"body":27},2968,"Cluster - GMP Annex 11","annex-11","2026-06-01T10:49:51.835Z","2026-06-01T14:00:26.564Z","2026-06-01T14:14:51.537Z","enixj3ogedv9cvqkr1e9naia","en",false,{"id":15,"name":16,"slug":17,"createdAt":18,"updatedAt":19,"publishedAt":20,"documentId":21,"locale":12},4,"Temperature compliance","regulations-temperature-compliance","2024-01-02T10:06:44.858Z","2024-01-22T15:12:40.797Z","2024-01-02T10:06:46.614Z","i1q35riy47k9l6e5el54twtt",null,{"id":24,"pageTitle":25,"shortDescription":26,"noIndex":13,"noAI":13,"noFollow":13,"Schema":22,"canonicalURL":22,"ogTitle":22,"ogDescription":22,"noSitemap":13,"image":22},3905,"EU GMP Annex 11: Computerised Systems Requirements 2026","What EU GMP Annex 11 requires in 2026 for computerised systems: audit trails, validation review, ALCOA+, and a practical readiness walkthrough.",[28,112,146,153,181,187,218,246,271,276,280,285,309,345],{"__component":29,"id":30,"title":31,"content":32,"blockId":22,"ulStyle":22,"video":22,"auto play":13,"imageLeftTextRight":13,"preTitle":22,"preTitleColor":22,"ctaInfoText":22,"titleLevel":33,"imageUrl":22,"subTitle":22,"verticalCenteredText":34,"hideOnMobile":13,"hideTopDecoration":13,"hideLastUpdated":13,"buttons":35,"media":43,"employee":69},"blocks.media-and-text-split-view",14087,"EU GMP Annex 11: What it requires for computerized systems in pharma","Annex 11 sets the rules for computerized systems in GxP environments: audit trails, validation status, access controls, and data integrity. The July 2025 draft expanded the standard from 5 to 19 pages, restructured into 17 sections. If your temperature monitoring system runs on software, Annex 11 applies to it.\n\nHere is what EU GMP Annex 11 requires in 2026, what changed in the July 2025 draft, and how to align a temperature monitoring setup with the updated expectations.\n\n_Not to be confused with ICAO Annex 11 (air traffic services) or EU MDR Annex XI._","h2",true,[36],{"id":37,"title":38,"href":39,"type":40,"size":41,"arrow":42,"blockId":22,"fullWidth":13,"quizId":22,"icon":22,"lucideIcon":22},13649,"Download a full GMP audit checklist","#form","black","default","down",{"id":44,"name":45,"alternativeText":22,"caption":22,"width":46,"height":47,"formats":48,"hash":61,"ext":50,"mime":53,"size":62,"url":63,"previewUrl":22,"provider":64,"provider_metadata":65,"createdAt":66,"updatedAt":66,"documentId":67,"publishedAt":68,"focalPoint":22},2122,"GMP annex 11.png",1488,975,{"thumbnail":49},{"ext":50,"url":51,"hash":52,"mime":53,"name":54,"path":22,"size":55,"width":56,"height":57,"sizeInBytes":58,"provider_metadata":59},".png","https:\u002F\u002Fres.cloudinary.com\u002Feupry\u002Fimage\u002Fupload\u002Fv1780316463\u002Fthumbnail_GMP_annex_11_2234d18e45.png","thumbnail_GMP_annex_11_2234d18e45","image\u002Fpng","thumbnail_GMP annex 11.png",46.07,238,156,46073,{"public_id":52,"resource_type":60},"image","GMP_annex_11_2234d18e45",321.92,"https:\u002F\u002Fres.cloudinary.com\u002Feupry\u002Fimage\u002Fupload\u002Fv1780316463\u002FGMP_annex_11_2234d18e45.png","cloudinary",{"public_id":61,"resource_type":60},"2026-06-01T12:21:04.391Z","vsq5auq7xz2131nrfhh1knp8","2026-06-01T12:21:04.392Z",{"id":70,"name":71,"workTitle":72,"testimonial":73,"email":22,"linkedIn":74,"createdAt":75,"updatedAt":76,"publishedAt":77,"documentId":78,"locale":12,"url":22,"image":79,"thumbnail":22,"localizations":104},191,"Adam Hartmann-Kruckow","CCO  & co-founder","After my internship in Eupry, I started working full-time as a Key Account Manager.\n\nEupry has not only introduced me to new friends but has developed me as a human and taught me valuable lessons and skills about responsibility, teamwork, and building up a well-working sales department.","https:\u002F\u002Fwww.linkedin.com\u002Fin\u002Fadam-hartmann-kruckow-63672831\u002F","2023-11-13T09:44:15.601Z","2025-05-22T14:28:23.507Z","2025-05-22T14:28:23.547Z","mtcps4rkmkjzs82xstm7oqit",{"id":80,"name":81,"alternativeText":82,"caption":22,"width":83,"height":84,"formats":85,"hash":96,"ext":87,"mime":90,"size":97,"url":98,"previewUrl":22,"provider":64,"provider_metadata":99,"createdAt":100,"updatedAt":101,"documentId":102,"publishedAt":103,"focalPoint":22},638,"2021.12.16_adam1-scaled.jpg","Smiling man in dark suit and burgundy tie against light background, professional headshot",400,582,{"thumbnail":86},{"ext":87,"url":88,"hash":89,"mime":90,"name":91,"path":22,"size":92,"width":93,"height":57,"sizeInBytes":94,"provider_metadata":95},".jpg","https:\u002F\u002Fres.cloudinary.com\u002Feupry\u002Fimage\u002Fupload\u002Fv1759823784\u002Fthumbnail_2021_12_16_adam1_scaled_cc1055fda3.jpg","thumbnail_2021_12_16_adam1_scaled_cc1055fda3","image\u002Fjpeg","thumbnail_2021.12.16_adam1-scaled.jpg",3.42,107,3415,{"public_id":89,"resource_type":60},"2021_12_16_adam1_scaled_cc1055fda3",108.46,"https:\u002F\u002Fres.cloudinary.com\u002Feupry\u002Fimage\u002Fupload\u002Fv1759823784\u002F2021_12_16_adam1_scaled_cc1055fda3.jpg",{"public_id":96,"resource_type":60},"2024-02-04T13:07:51.900Z","2026-03-26T11:15:31.333Z","wbc2bo6hj4hguafjulsat5op","2025-01-29T12:38:47.261Z",[105],{"id":106,"name":71,"workTitle":107,"testimonial":108,"email":22,"linkedIn":74,"createdAt":109,"updatedAt":109,"publishedAt":110,"documentId":78,"locale":111,"url":22},215,"CCO & Mitgründer","Nach meinem Praktikum bei Eupry begann ich als Key Account Manager in Vollzeit zu arbeiten.\n\nEupry hat mir nicht nur neue Freunde gebracht, sondern mich auch als Mensch weiterentwickelt und mir wertvolle Lektionen und Fähigkeiten in den Bereichen Verantwortung, Teamarbeit und dem Aufbau einer gut funktionierenden Vertriebsabteilung vermittelt.","2026-05-28T14:25:01.246Z","2026-05-28T14:25:01.707Z","de",{"__component":113,"id":114,"title":115,"description":22,"blockId":22,"imageUrl":22,"layout":116,"hideOnMobile":13,"items":117,"media":22},"blocks.table-of-contents",219,"Table of contents","fullWidth",[118,122,126,130,134,138,142],{"id":119,"label":120,"link":121},1344,"What is EU GMP Annex 11?","#what",{"id":123,"label":124,"link":125},1345,"What does Annex 11 require?","#require",{"id":127,"label":128,"link":129},1346,"What does ALCOA+ mean for temperature data?","#alcoa",{"id":131,"label":132,"link":133},1347,"What is changing in the Annex 11 2025 draft update?","#2025",{"id":135,"label":136,"link":137},1348,"How to get your monitoring setup Annex 11-ready","#monitoring",{"id":139,"label":140,"link":141},1349,"Where traditional workflows struggle to meet Annex 11","#traditional",{"id":143,"label":144,"link":145},1350,"FAQ about Annex 11","#faq",{"__component":147,"id":148,"text":149,"columns":150,"title":120,"blockId":151,"hideOnMobile":13,"ulStyle":22,"ulColor":22,"buttons":152},"blocks.text",4033,"EU GMP Annex 11 is the European regulation that governs computerized systems used in [GxP](\u002Fregulations-temperature-compliance\u002FgxP) environments. It sits in EudraLex Volume 4, the EU Guidelines on Good Manufacturing Practice, alongside the other annexes that cover sterile manufacturing, qualification and validation, and documentation.\n\nThe scope is broad. Any software that touches a [GMP](\u002Fregulations-temperature-compliance\u002Fgmp), [GDP](\u002Fgdp), or GLP process falls within it: ERP, LIMS, MES, batch release systems, temperature monitoring platforms, mapping software, calibration databases. If the system holds, processes, or transmits data that supports a regulatory decision, Annex 11 applies.\n\nAccountability stays with the Marketing Authorisation Holder. A vendor can claim its software is \"Annex 11 compliant,\" but the regulatory obligation belongs to the company running the GxP process – not the SaaS provider behind it. That distinction matters when an inspector asks for evidence.\n\nGeographically, Annex 11 covers the EU and EEA. It is also referenced by the UK MHRA post-Brexit, by Swissmedic, and by WHO prequalification – meaning a system aligned with Annex 11 typically meets expectations across most major regulated markets outside the US.\n\n**Also read**: [How to meet GMP temperature requirements](\u002Fregulations-temperature-compliance\u002Fgmp)","one","what",[],{"__component":29,"id":154,"title":124,"content":155,"blockId":156,"ulStyle":22,"video":22,"auto play":13,"imageLeftTextRight":13,"preTitle":22,"preTitleColor":22,"ctaInfoText":22,"titleLevel":33,"imageUrl":22,"subTitle":22,"verticalCenteredText":13,"hideOnMobile":13,"hideTopDecoration":13,"hideLastUpdated":13,"buttons":157,"media":158,"employee":22},14081,"EU [GMP](\u002Fregulations-temperature-compliance\u002Fgmp) Annex 11 governs how computerized systems are validated, operated, and controlled in regulated pharmaceutical environments. The requirements cover the full lifecycle: from initial validation through ongoing operation, change control, and eventual retirement.\n\nThe core obligations are well established. Your system must be validated. Audit trails must capture who did what and when. Access must be controlled by role. Data integrity must follow ALCOA+ principles - Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available. These are not new ideas. What changes with each revision is the depth of expectation around each area.\n\nFor [temperature monitoring](\u002Ftemperature-monitoring) specifically, Annex 11 requirements mean your monitoring platform carries the same documentation burden as any other GxP system. The software is in scope. The audit trail is in scope. The validation records are in scope.","require",[],{"id":159,"name":160,"alternativeText":161,"caption":22,"width":162,"height":163,"formats":164,"hash":174,"ext":87,"mime":90,"size":175,"url":176,"previewUrl":22,"provider":64,"provider_metadata":177,"createdAt":178,"updatedAt":179,"documentId":180,"publishedAt":178,"focalPoint":22},1961,"Checklist.jpg","Isometric illustration of a clipboard checklist with four teal checkmarks on a light blue gradient background",1879,1144,{"thumbnail":165},{"ext":87,"url":166,"hash":167,"mime":90,"name":168,"path":22,"size":169,"width":170,"height":171,"sizeInBytes":172,"provider_metadata":173},"https:\u002F\u002Fres.cloudinary.com\u002Feupry\u002Fimage\u002Fupload\u002Fv1774009650\u002Fthumbnail_Checklist_5e67060c61.jpg","thumbnail_Checklist_5e67060c61","thumbnail_Checklist.jpg",2.36,245,149,2363,{"public_id":167,"resource_type":60},"Checklist_5e67060c61",211.47,"https:\u002F\u002Fres.cloudinary.com\u002Feupry\u002Fimage\u002Fupload\u002Fv1774009650\u002FChecklist_5e67060c61.jpg",{"public_id":174,"resource_type":60},"2026-03-20T12:27:31.463Z","2026-03-26T11:34:30.298Z","q5a9kgewyevl9azcnkpmy3oc",{"__component":182,"id":183,"title":184,"content":185,"video":22,"blockId":22,"ulStyle":41,"preTitle":22,"preTitleColor":22,"titleLevel":33,"imageUrl":22,"subTitle":22,"videoAutoplay":22,"hideOnMobile":22,"ctaInfoText":22,"hideLastUpdated":22,"buttons":186,"media":22,"employee":22},"blocks.media-and-text",3776,"What ALCOA+ means for temperature data","ALCOA+ defines what counts as trustworthy data in GxP environments. For temperature monitoring, each principle translates to a specific system capability:\n\n- **Attributable:** Every reading, alarm, user action, and data change is linked to a named user, device, or process with timestamp. You can answer who recorded the data.\n- **Legible:** Records remain readable throughout the retention period, in electronic format and any required printouts.\n- **Contemporaneous:** Data is captured at the time of measurement, with timestamps from a validated time source – not transcribed later.\n- **Original:** Readings are recorded directly by calibrated sensors. Manual entry is permitted only when specifically designed and validated.\n- **Accurate:** Loggers are calibrated to ISO 17025-traceable standards. Any correction is documented through formal change control.\n- **Complete:** All measurements are retained – including out-of-spec readings, alarms, and system errors. Deletions remain visible in the audit trail.\n- **Consistent:** Date and time formats, units, intervals, and structures stay uniform across the system.\n- **Enduring:** Records are stored on validated media with regular backups, accessible for the full retention period – typically 5-10 years in GMP environments.\n- **Available:** Authorized users can retrieve records quickly for investigations, audits, and inspections.\n\nALCOA+ compliance is not a separate workstream from Annex 11 – it is how Annex 11 defines data integrity in practice.",[],{"__component":188,"id":189,"title":190,"lead":191,"hubspotFormId":192,"blockId":193,"hubspotMeetingUrl":22,"titleLevel":33,"preTitle":194,"preTitleColor":195,"imageUrl":22,"hideOnMobile":22,"media":196},"blocks.download-form",3330,"Download an audit checklist for GMP","What do auditors look for in your temperature monitoring, mapping, and calibration processes?\n\nGet an easy overview of the key areas regulators typically examine during GMP inspections.","191cb750-6f0c-4042-89f5-fcf7b782a862","form","Checklist","Brain Freeze Dark",{"id":197,"name":198,"alternativeText":199,"caption":22,"width":200,"height":201,"formats":202,"hash":211,"ext":50,"mime":53,"size":212,"url":213,"previewUrl":22,"provider":64,"provider_metadata":214,"createdAt":215,"updatedAt":216,"documentId":217,"publishedAt":215,"focalPoint":22},1159,"Checklist for GMP Mockup.png","Three-page mockup of Eupry's Thermal Compliance Audit Checklist for GMP Companies booklet with gradient cover",2243,2156,{"thumbnail":203},{"ext":50,"url":204,"hash":205,"mime":53,"name":206,"path":22,"size":207,"width":208,"height":57,"sizeInBytes":209,"provider_metadata":210},"https:\u002F\u002Fres.cloudinary.com\u002Feupry\u002Fimage\u002Fupload\u002Fv1750233829\u002Fthumbnail_Checklist_for_GMP_Mockup_122b6fbed4.png","thumbnail_Checklist_for_GMP_Mockup_122b6fbed4","thumbnail_Checklist for GMP Mockup.png",38.61,162,38609,{"public_id":205,"resource_type":60},"Checklist_for_GMP_Mockup_122b6fbed4",4113.11,"https:\u002F\u002Fres.cloudinary.com\u002Feupry\u002Fimage\u002Fupload\u002Fv1750233831\u002FChecklist_for_GMP_Mockup_122b6fbed4.png",{"public_id":211,"resource_type":60},"2025-06-18T08:03:52.102Z","2026-03-26T11:06:03.402Z","s7tmteynir76nbs5d0ubvi9o",{"__component":29,"id":219,"title":132,"content":220,"blockId":221,"ulStyle":22,"video":22,"auto play":13,"imageLeftTextRight":13,"preTitle":22,"preTitleColor":22,"ctaInfoText":22,"titleLevel":33,"imageUrl":22,"subTitle":22,"verticalCenteredText":34,"hideOnMobile":13,"hideTopDecoration":13,"hideLastUpdated":13,"buttons":222,"media":223,"employee":22},14082,"The [July 2025 Annex 11 draft](https:\u002F\u002Fhealth.ec.europa.eu\u002Fconsultations\u002Fstakeholders-consultation-eudralex-volume-4-good-manufacturing-practice-guidelines-chapter-4-annex_en) is the most significant Annex 11 update in over a decade. The document grew from 5 to 19 pages, restructured into 17 sections – a signal of how regulator expectations have shifted since the 2011 version. The comment period closed on October 7, 2025, and the final version is expected in mid-2026.\n\nThe same release also introduced Annex 22 on AI-based systems and a revised Chapter 4 on documentation. Together, the three documents redraw the rules for digital compliance under EU GMP.\n\nThe Annex 11 changes that matter most for quality teams fall into four areas. Each one tightens an expectation that was previously handled by interpretation.\n\n- **Audit trail scope:** Audit trails must now capture data creation events, not only changes and deletions. If a temperature reading is logged, that log event itself must be traceable.\n- **Periodic validation review:** Validation status must be reviewed on a documented schedule. A one-time [IQ\u002FOQ\u002FPQ](https:\u002F\u002Feupry.com\u002Fiq-oq-pq\u002F) is no longer sufficient without evidence of ongoing review.\n- **Cybersecurity and access management:** Dedicated sections now address access controls, user authentication, and system security – previously covered only by implication.\n- **Penetration testing:** Critical systems may require regular penetration testing. This is a materially new expectation for most pharma IT and quality teams.\n\n### Expanded audit trail requirements\n\n- Audit trails must be enabled at all times and cannot be disabled by normal system users\n- Must capture data creation as well as changes and deletions, aligning closer to 21 CFR Part 11\n- Automated alerts should flag suspicious patterns: bulk deletions, after-hours modifications, repeated failed login attempts\n- Regular audit trail reviews must be documented, with defined frequency, scope, and responsibilities\n- Reviews should be risk-based, focusing on critical data points and high-risk activities\n- Calibration certificate uploads, sensor replacements, and system configuration changes affecting how temperature data is collected must all be captured\n\n### Enhanced identity and access management\n\n- New dedicated section on access controls with multiple subsections\n- Stronger requirements for unique user accounts and role-based permissions\n- Better guidance on account lifecycle management – onboarding, role changes, offboarding\n\n### Mandatory periodic review\n\n- New requirement aligning computerised systems with equipment and facility periodic review expectations\n- Systems must be verified as remaining validated and fit for purpose at defined intervals\n- Review frequency under the draft: monthly for high-risk systems, quarterly for routine systems, and always before batch release when temperature data supports the release decision\n\n### Cybersecurity requirements\n\n- Dedicated section on IT security covering firewalls, patch management, and virus protection\n- Disaster recovery expectations including documented RTO and RPO metrics\n- Regular penetration testing required for critical systems\n\nOrganizations should begin aligning monitoring systems with the draft expectations now. Retroactive changes to legacy systems are complex and costly, and the final version is expected in mid-2026.","2025",[],{"id":224,"name":225,"alternativeText":226,"caption":22,"width":227,"height":228,"formats":229,"hash":238,"ext":87,"mime":90,"size":239,"url":240,"previewUrl":22,"provider":64,"provider_metadata":241,"createdAt":242,"updatedAt":243,"documentId":244,"publishedAt":245,"focalPoint":22},1528,"Harmonizing02.jpg","Isometric illustration of a secured document with a padlock and a verified certification badge with ribbon",1198,886,{"thumbnail":230},{"ext":87,"url":231,"hash":232,"mime":90,"name":233,"path":22,"size":234,"width":235,"height":57,"sizeInBytes":236,"provider_metadata":237},"https:\u002F\u002Fres.cloudinary.com\u002Feupry\u002Fimage\u002Fupload\u002Fv1763037368\u002Fthumbnail_Harmonizing02_4fe69efbbb.jpg","thumbnail_Harmonizing02_4fe69efbbb","thumbnail_Harmonizing02.jpg",5.21,211,5209,{"public_id":232,"resource_type":60},"Harmonizing02_4fe69efbbb",227.49,"https:\u002F\u002Fres.cloudinary.com\u002Feupry\u002Fimage\u002Fupload\u002Fv1763037368\u002FHarmonizing02_4fe69efbbb.jpg",{"public_id":238,"resource_type":60},"2025-11-13T12:36:08.765Z","2026-03-26T11:21:14.553Z","v3s4vkrlqzpr5830qlfuu7x6","2025-11-13T12:36:08.766Z",{"__component":29,"id":247,"title":136,"content":248,"blockId":249,"ulStyle":22,"video":22,"auto play":13,"imageLeftTextRight":13,"preTitle":22,"preTitleColor":22,"ctaInfoText":22,"titleLevel":33,"imageUrl":22,"subTitle":22,"verticalCenteredText":34,"hideOnMobile":13,"hideTopDecoration":13,"hideLastUpdated":13,"buttons":250,"media":256,"employee":22},14088,"Getting your monitoring setup aligned with Annex 11 requirements does not require a full-scale project. It requires working through the right steps in the right order. Here is a practical sequence for quality teams assessing or updating their monitoring setup.\n\n1. **Assess your current system against the draft scope.** Map your [monitoring software](https:\u002F\u002Feupry.com\u002Fsolutions\u002Ftemperature-monitoring-software\u002F) against the updated audit trail, access control, and validation review requirements. Identify where your documentation has gaps relative to the 2025 draft language.\n2. **Confirm audit trail coverage for data creation events.** Check whether your system logs the creation of temperature records, not only modifications or deletions. This is the most common gap under the updated standard.\n3. **Document a periodic validation review schedule.** Set a defined frequency – monthly for high-risk applications, quarterly for routine – and assign ownership. The review itself matters less than the documented evidence it occurred.\n4. **Link calibration certificates to sensor records.** Your audit trail is only as credible as the calibration evidence behind it. Certificates must be traceable to the individual sensor and the data it produced.\n\nThese steps apply regardless of which [monitoring system](\u002Ftemperature-monitoring) you use. The logic is consistent with the ISPE Good Practice Guide and with how [EU GDP guidelines](\u002Fgdp\u002F) approach risk-based qualification.","monitoring",[251],{"id":252,"title":253,"href":254,"type":40,"size":41,"arrow":255,"blockId":22,"fullWidth":13,"quizId":22,"icon":22,"lucideIcon":22},13650,"See how Eupry's automated monitoring solution works","\u002Fsolutions\u002Fmonitoring","right",{"id":257,"name":258,"alternativeText":259,"caption":22,"width":260,"height":261,"formats":22,"hash":262,"ext":263,"mime":264,"size":265,"url":266,"previewUrl":22,"provider":64,"provider_metadata":267,"createdAt":268,"updatedAt":269,"documentId":270,"publishedAt":268,"focalPoint":22},1699,"System Setup & On-site Installation.svg","Isometric diagram of three Eupry server clusters connected via cloud to a mobile device and desktop monitor",1200,958,"System_Setup_and_On_site_Installation_dd7caad352",".svg","image\u002Fsvg+xml",106.19,"https:\u002F\u002Fres.cloudinary.com\u002Feupry\u002Fimage\u002Fupload\u002Fv1766090298\u002FSystem_Setup_and_On_site_Installation_dd7caad352.svg",{"public_id":262,"resource_type":60},"2025-12-18T20:38:21.370Z","2026-04-24T08:03:57.115Z","gtr7r66ok2texqtq52d3vt6v",{"__component":272,"id":273,"title":274,"content":275,"blockId":22,"imageUrl":22,"hideOnMobile":13,"media":22},"blocks.media-and-text-overflow-media",718,"Annex 11 compliance checklist","Before using any computerised temperature monitoring system for GMP purposes, confirm:\n\n- System validation documentation (IQ\u002FOQ\u002FPQ protocols) completed and approved\n- Risk assessment documenting validation scope and critical functions\n- Audit trails enabled and cannot be disabled by normal users\n- All user accounts have unique credentials, with no shared logins\n- Role-based permissions configured to limit access appropriately\n- Electronic signatures configured, where used, with two-factor identification\n- Backup procedures documented and tested successfully\n- Data retention procedures meeting regulatory requirements – typically 5-10 years\n- Disaster recovery procedures documented and tested\n- Calibration certificates for all sensors stored and linked in the system\n- Change control procedures for system updates and configuration changes\n- Training records for all users documented\n- Periodic review schedule established, per draft Annex 11 requirements",{"__component":147,"id":277,"text":278,"columns":150,"title":140,"blockId":22,"hideOnMobile":13,"ulStyle":22,"ulColor":22,"buttons":279},4034,"The gap between what Annex 11 requires and what traditional manual processes deliver is where audit findings come from. The table below shows what the daily workflow looks like with a fragmented, manual setup – and what it looks like when it is automated.\n\n| Manual \u002F fragmented approach | Automated, Annex 11-ready approach |\n| --- | --- |\n| Audit trails exported manually from separate systems, collated in spreadsheets | Automated audit trail exports, complete and timestamped, available on demand |\n| Validation records stored in shared drives, version control unreliable | Validation status tied to the system, periodic review scheduled and documented |\n| Access managed through generic logins or shared credentials | Role-based access controls with individual user accountability |\n| Temperature excursion responses documented after the fact, inconsistently | Standardized excursion workflow with timestamped response trail |\n| Calibration certificates filed separately, not linked to sensor data | Calibration certificates linked directly to sensors and audit records |\n\nThe manual approach does not fail because people are careless. It fails because the structure makes consistency nearly impossible at scale. Each manual step is a gap waiting to surface under inspection.\n\n> Eupry's system offers a highly user-friendly day-to-day interface. Eupry delivers a turnkey service enabling us to be more efficient in our work with compliance so we can deliver quality products to our customers.\n>\n> *Eric Clausen, Distribution Manager at Freja*\n",[],{"__component":182,"id":281,"title":282,"content":283,"video":22,"blockId":22,"ulStyle":22,"preTitle":22,"preTitleColor":22,"titleLevel":33,"imageUrl":22,"subTitle":22,"videoAutoplay":34,"hideOnMobile":13,"ctaInfoText":22,"hideLastUpdated":13,"buttons":284,"media":22,"employee":22},3777,"How Eupry supports Annex 11 compliance","Eupry is built as a closed system, which matters for Annex 11 because closed system architecture simplifies accountability and limits the surface area for access control failures. Every user action is logged. Every record is immutable. Every calibration certificate is linked to the sensor that produced the data.\n\nThe platform provides ALCOA+-compliant records, automated audit trail exports, role-based access controls, and real-time excursion alerts with documented response workflows. For organizations subject to FDA oversight as well, a dedicated [FDA 21 CFR Part 11 compliance](https:\u002F\u002Feupry.com\u002Fguides\u002F21-cfr-part-11-compliance\u002F) module is available – covering digital signatures, complete traceability, and immutable audit logs for cross-jurisdictional requirements.\n\nThe 2025 Annex 11 update raises expectations around periodic validation review and cybersecurity. Eupry's validation documentation supports structured periodic review, and the platform is built to GAMP5 standards. 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