1What the letters mean.
ALCOA and its extensions name the attributes that regulated data and records should have throughout their life cycle, on paper or electronically.¹ PIC/S sets out what each one requires, and FDA’s data integrity guidance points to the parts of the drug CGMP regulations, 21 CFR 211, that address the first five.¹²
| Attribute | What it requires | Where FDA finds it in 21 CFR 211 |
|---|---|---|
| Attributable | It should be possible to identify the person or computerised system that performed a task and when, including who changed a record, when and why.¹ | 211.101(d), 211.122, 211.186, 211.188(b)(11)² |
| Legible | Records are readable and unambiguous. Where the ability to search, query or trend electronic data matters to their content and meaning, the ability to interact with them through a suitable application matters to the record’s availability.¹ | 211.180(e)² |
| Contemporaneous | Actions, events and decisions are recorded as they take place.¹ | 211.100(b), 211.160(a)² |
| Original | The first capture of information, on paper or electronically; information first captured in a dynamic state should remain available in that state.¹ FDA says “original or a true copy”.² | 211.180, 211.194(a)² |
| Accurate | Records are a truthful representation of facts, supported by qualification, calibration, computer validation, data review, deviation management and trained staff.¹ | 211.22(a), 211.68, 211.188² |
| Complete | All information critical to recreating an event is kept, including the metadata of electronic data.¹ | |
| Consistent | Data are created, processed and stored in a logical, defined way, with controls such as chronological sequencing, date formats, units and rounding.¹ | |
| Enduring | Records remain intact and accessible as a durable record for the whole retention period.¹ | |
| Available | Records can be reviewed at any time during the retention period, in a readable format, by the people responsible.¹ | |
| Traceable (ALCOA++) | Changes to data and their context are traceable, do not obscure the original information and are explained where necessary.³ |
2Who uses which acronym.
| Source | Status | Acronym |
|---|---|---|
| FDA, Data Integrity and Compliance With Drug CGMP, December 2018 | Final guidance, US drugs | ALCOA: data integrity is “the completeness, consistency, and accuracy of data”, and such data “should be attributable, legible, contemporaneously recorded, original or a true copy, and accurate (ALCOA)”.² |
| MHRA, GxP Data Integrity Guidance and Definitions, March 2018 | UK guidance, all GxP | Uses ALCOA, defines ALCOA+, and says “There is no difference in expectations regardless of which acronym is used”.⁴ |
| WHO, TRS 1033 Annex 4, Guideline on data integrity, 2021 | WHO guideline | ALCOA+.⁵ |
| PIC/S PI 041-1, 1 July 2021 | Inspectorate guidance, GMP and GDP | ALCOA+.¹ |
| EMA, Guideline on computerised systems and electronic data in clinical trials, March 2023 | Final guideline, EU clinical trials | ALCOA++, with “available when needed” and “traceable”.³ |
| Draft revised EU GMP Chapter 4, Documentation, 2025 | Draft for consultation | ALCOA++, with traceable.⁶ |
MHRA explains that ALCOA was historically regarded as defining the attributes of data quality suitable for regulatory purposes, and that the “+” was added later “to emphasise the requirements”.⁴ The draft Chapter 4 describes complete, consistent, enduring, available and traceable as “implicit basic ALCOA principles”, and defines traceability as “the ability to trace the history, modification or location of data by means of recorded identifications”.⁶ The draft was consulted on from July to October 2025.⁷ The European Commission still lists the January 2011 Chapter 4 as the version in EudraLex Volume 4.⁸
3What the attributes look like in practice.
WHO gives a weighing example of contemporaneous recording: the weight, date, time, person and balance identification are recorded when the sample is weighed, “not before or at a later stage”, and electronic data are date- and time-stamped automatically. A scribe may record for someone else only exceptionally, such as for aseptic line interventions, with both people identified.⁵ EMA adds that accurate date and time information should be captured automatically and set by an external standard.³
For electronic records, metadata carry much of the meaning. FDA’s example is that the number “23” is meaningless without the unit “mg”, and that the audit trail for an HPLC run should include the user, the date and time of the run, the integration parameters and details of any reprocessing, with a justification.² PIC/S accepts electronic raw data kept as paper or PDF only where the static record keeps the integrity of the original, including metadata, audit trails and processing runs, and calls this approach “likely to be onerous”.¹
Corrections should leave the original visible. MHRA asks for corrections that give “visibility of the original record, and traceability of the correction, using ALCOA principles”.⁴ WHO asks for a regular review of paper and electronic data for consistency with ALCOA+, in day-to-day work as well as in audits and self-inspections, with effort “commensurate with the risk and impact of a data integrity failure”. Where a legacy system cannot support ALCOA+ by design, for example because it has no audit trail, WHO allows mitigation for defined temporary periods, such as add-on software or paper-based controls.⁵
4How it runs in Seal.
Seal keeps with each record the user, API key or trigger behind each entry, the capture time, the original file and its source reference, and each change as a new version linked to the earlier ones, as the data integrity blueprint sets out. Where a source system such as a chromatography data system keeps its own audit trail, that trail stays authoritative there; its export is attached to the Seal record and reviewed beside it, and a required review can hold the decision until it is done.
Each record keeps its audit history and electronic signatures, with controls to support 21 CFR Part 11 and EU GMP Annex 11, as the regulatory overview describes, and lab, manufacturing and quality work run on one platform of linked records.
References
- 1PI 041-1, Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments, PIC/S, 1 July 2021. https:/
/ picscheme. org/ docview/ 4234 (read 6 November 2026) - 2Data Integrity and Compliance With Drug CGMP: Questions and Answers, Guidance for Industry, FDA, December 2018. https:/
/ www. fda. gov/ media/ 119267/ download (read 6 November 2026) - 3Guideline on computerised systems and electronic data in clinical trials, EMA/
INS/ GCP/ 112288/ 2023, EMA GCP Inspectors Working Group, 9 March 2023. https:/ / www. ema. europa. eu/ en/ documents/ regulatory- procedural- guideline/ guideline- computerised- systems- and- electronic- data- clinical- trials_ en. pdf (read 6 November 2026) - 4GXP Data Integrity Guidance and Definitions, Revision 1, MHRA, March 2018. https:/
/ assets. publishing. service. gov. uk/ media/ 5aa2b9ede5274a3e391e37f3/ MHRA_ GxP_ data_ integrity_ guide_ March_ edited_ Final. pdf (read 6 November 2026) - 5WHO Technical Report Series No. 1033, Annex 4, Guideline on data integrity, World Health Organization, 2021. https:/
/ cdn. who. int/ media/ docs/ default- source/ medicines/ norms- and- standards/ guidelines/ inspections/ trs1033- annex4- guideline- on- data- integrity. pdf (read 6 November 2026) - 6EudraLex Volume 4, Chapter 4, Documentation, draft revision for consultation, European Commission, July 2025. https:/
/ health. ec. europa. eu/ document/ download/ fa336a6e- 753b- 46fc- b53b- 9178bacd8878_ en?filename=mp_ vol4_ chap4_ consultation_ guideline_ en. pdf (read 6 November 2026) - 7Stakeholders’ Consultation on EudraLex Volume 4, Chapter 4, Annex 11 and New Annex 22, European Commission, July 2025. https:/
/ health. ec. europa. eu/ consultations/ stakeholders- consultation- eudralex- volume- 4- good- manufacturing- practice- guidelines- chapter- 4- annex_ en (read 6 November 2026) - 8EudraLex Volume 4, Good Manufacturing Practice guidelines, European Commission. https:/
/ health. ec. europa. eu/ medicinal- products/ eudralex/ eudralex- volume- 4_ en (read 6 November 2026)
AQuestions and answers
Is ALCOA+ a legal requirement?
The acronym comes from guidance, but FDA says the characteristics behind it are addressed throughout the drug CGMP regulations, and maps each one to sections of 21 CFR 211, such as recording at the time of performance under 211.100(b). In the EU, the draft revision of the GMP documentation chapter would write ALCOA++ into the GMP guidelines.
Does ALCOA+ apply to paper records as well as electronic data?
Yes. PIC/S and WHO apply the same principles to paper, electronic and hybrid records. On paper that means indelible ink, controlled and reconciled blank forms, and corrections made with a single line that leaves the original readable; electronically it means audit trails, automatic time stamps and preserved metadata.
What counts as the original record for electronic data?
The first capture of the information. Data first captured in a dynamic form, such as a chromatogram that can be reprocessed, should stay available in that form. A printout or PDF can only stand in for it if it preserves everything needed to reconstruct the activity, including metadata and audit trails, which PIC/S expects to be onerous.
How does data integrity relate to ALCOA+?
Data integrity is the goal: FDA defines it as the completeness, consistency and accuracy of data. ALCOA+ lists the attributes data need to reach it, and data governance is the sum of arrangements that assure data have those attributes, whatever the format.
Can someone record data on another person’s behalf?
Only exceptionally, where the act of recording would put the product or activity at risk, such as line interventions in an aseptic area. The second person records at the time of the task, the record names both the person doing it and the person writing it, the operator countersigns where possible, and an approved procedure says which activities this applies to.