--- title: "ALCOA+, Definition | MedTech Terms" description: "Data integrity principles: Attributable, Legible, Contemporaneous, Original, Accurate (plus Complete, Consistent, Enduring, Available)." lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/alcoa-plus#term", "name": "ALCOA+", "description": "ALCOA+ is the data integrity framework regulators apply to clinical, manufacturing, and quality records. 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These principles ensure data integrity throughout its lifecycle." } }, { "@type": "Question", "name": "Why is ALCOA+ important in MedTech?", "acceptedAnswer": { "@type": "Answer", "text": "ALCOA+ is crucial in MedTech because it ensures the reliability, trustworthiness, and traceability of data used in clinical trials, manufacturing, and quality processes, which is essential for patient safety, product efficacy, and regulatory compliance (e.g., 21 CFR 820, ISO 13485)." } }, { "@type": "Question", "name": "How do electronic systems impact ALCOA+?", "acceptedAnswer": { "@type": "Answer", "text": "Electronic systems, such as Electronic Health Records (EHRs) and electronic Case Report Forms (eCRFs), must be designed and validated to support all ALCOA+ principles, including secure access, audit trails, and data persistence, in compliance with regulations like 21 CFR Part 11 and EU Annex 11." } } ] } ] } --- [ MedTech Terms The authoritative reference ](/) Browse Learn [Latest](/latest) About 1. [Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Clinical & Trials](/terms?cat=Clinical%20%26%20Trials) 6. / 7. ALCOA+ [All terms](/terms) Clinical & Trials [Clinical Evidence](/ecosystems/clinical-evidence) # ALCOA+ Data integrity principles: Attributable, Legible, Contemporaneous, Original, Accurate (plus Complete, Consistent, Enduring, Available). Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed May 5, 2026 ## Definition ALCOA+ is the data integrity framework regulators apply to clinical, manufacturing, and quality records. The '+' adds Complete, Consistent, Enduring, and Available to the original ALCOA principles. What the regulation says Regulators and standards bodies, such as the FDA (e.g., in their guidance on Data Integrity and Compliance with cGMP) and the EMA (through EU GMP Annex 11), emphasize ALCOA+ principles to ensure the trustworthiness and reliability of data. These principles are foundational for demonstrating compliance with quality system regulations, including those outlined in 21 CFR Part 11 for electronic records and electronic signatures, and for clinical trial data integrity as described in [ISO 14155](/terms/iso-14155). ## What this means in practice Common in 21 CFR Part 11, EU Annex 11, and [ISO 14155](/terms/iso-14155) audits. EHR exports, [eCRF](/terms/case-report-form) audit trails, and manual transcription practices are common ALCOA+ findings. ## Examples - A clinical trial site implements an electronic data capture system with audit trails that record every modification, demonstrating the "Attributable," "Contemporaneous," and "Enduring" aspects of ALCOA+. - A medical device manufacturer meticulously documents all calibration records for manufacturing equipment, ensuring the data is "Legible," "Original," and "Accurate" for regulatory audits. - During a software update for a diagnostic device, all historical patient data remains accessible and verifiable, fulfilling the "Available" and "Consistent" principles of ALCOA+. Common pitfalls - • Failing to implement robust access controls can compromise the "Attributable" principle of ALCOA+. - • Inadequate validation of electronic systems can lead to data integrity issues, particularly concerning the "Accurate" and "Consistent" principles. - • Not maintaining comprehensive audit trails makes it difficult to prove data integrity over time, violating the "Complete" and "Enduring" principles. - • Assuming that commercial off-the-shelf software inherently meets ALCOA+ without proper configuration and validation is a common mistake. ## Frequently asked questions What does ALCOA+ stand for? ALCOA+ stands for Attributable, Legible, Contemporaneous, Original, Accurate, plus Complete, Consistent, Enduring, and Available. These principles ensure data integrity throughout its lifecycle. Why is ALCOA+ important in MedTech? How do electronic systems impact ALCOA+? ## Cross-references ### Used by Things that build on this term. - [ ICH E6 Good Clinical Practice(GCP) ](/terms/ich-gcp) - [ Source Data Verification(SDV) ](/terms/sdv) ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Clinical & Trials ICH E6 Good Clinical Practice(GCP) International standard for the design, conduct, and reporting of clinical trials. ](/terms/ich-gcp)[ Standards ISO 14155 Good clinical practice for clinical investigations of medical devices. ](/terms/iso-14155) ### More in Clinical & Trials · Same category [ Clinical & Trials Adaptive Trial Design Trial design that pre-specifies opportunities to modify aspects (sample size, arms, endpoints) based on interim data. ](/terms/adaptive-trial)[ Clinical & Trials Adverse Event(AE) Any untoward medical occurrence in a subject, whether or not related to the device. ](/terms/adverse-event)[ Clinical & Trials Analytical Sensitivity An IVD's ability to detect small quantities of an analyte. ](/terms/analytical-sensitivity)[ Clinical & Trials Bayesian Trial Design Trial design that uses Bayesian statistics, often incorporating prior data from related studies or registries. ](/terms/bayesian-trial) Cited by Where this term appears across MedTech Terms. Ecosystems (1) - [Clinical Evidence](/ecosystems/clinical-evidence) ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 FDA· 1 ICH· 1 ISO· 1 1. [1 FDA Data Integrity Guidance Verified FDA · fda.gov ](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/data-integrity-and-compliance-drug-cgmp-questions-and-answers) 2. [2 ICH Guidelines Verified ICH · ich.org ](https://www.ich.org/page/ich-guidelines) 3. [3 ISO 14155 Standard Page Verified ISO · iso.org ](https://www.iso.org/standard/71690.html) Inline markers like \[1\] jump to the matching reference above. Sponsor note ### Clinical evidence intersecting with device security? We support clinical-stage MedTech teams whose investigational devices touch patient data or hospital networks. [Book a 30-minute discovery session](https://go.bluegoatcyber.com/meetings/blue-goat-cyber/discovery-session) - No obligation - Expert-led from minute one - NDA available on request MedTech Terms is a community resource sponsored by [Blue Goat Cyber](https://bluegoatcyber.com). Definitions are independent of any vendor. On this term Category Clinical & Trials Sources 3 Updated 5/5/2026 [Compare with another term](/compare?a=alcoa-plus) Learn in 60 seconds Card Lesson Quiz Data integrity principles: Attributable, Legible, Contemporaneous, Original, Accurate (plus Complete, Consistent, Enduring, Available). - · Common in 21 CFR Part 11, EU Annex 11, and ISO 14155 audits. - · EHR exports, eCRF audit trails, and manual transcription practices are common ALCOA+ findings. - · The '+' adds Complete, Consistent, Enduring, and Available to the original ALCOA principles. Remember this Watch out: Failing to implement robust access controls can compromise the "Attributable" principle of ALCOA+. Related terms - [ICH E6 Good Clinical Practice(GCP) ](/terms/ich-gcp) - [ISO 14155 ](/terms/iso-14155) You may also need Auto-suggested from Clinical & Trials and shared keywords. - [Investigator Brochure(IB) ](/terms/investigator-brochure) - [Risk-Based Monitoring(RBM) ](/terms/risk-based-monitoring) - [Source Data Verification(SDV) ](/terms/sdv) - [ICH E6(R3) Good Clinical Practice(E6(R3)) ](/terms/ich-e6-r3) - [Real-World Data(RWD) ](/terms/rwd) - [Due Diligence ](/terms/due-diligence) [All Clinical & Trials terms](/terms?cat=Clinical%20%26%20Trials) From the Blue Goat network Related resources and services on this topic. - [ MedTech Launchpad MedTech funding rounds, accelerators, and launch resources. ](https://medtechlaunchguide.com) MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. 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