ALCOA+Attributable, Legible, Contemporaneous, Original, Accurate — plus Complete, Consistent, Enduring, Available
ALCOA stands for attributable, legible, contemporaneous, original (or a true copy) and accurate. MHRA's 2018 GxP data integrity guidance (§3.10) defines the '+' as complete, consistent, enduring and available, and says expectations are the same whichever acronym is used.
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FDA's 2018 drug CGMP Q&A uses ALCOA.
On this page · 7 sections
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01The five ALCOA attributes and where U.S. drug CGMP rules state them
FDA's footnote maps each attribute to drug CGMP sections. The table shows those citations; it is not a full list of obligations.
| Attribute | Meaning | CFR sections FDA cites |
|---|---|---|
| Attributable | Who did it is recorded | 211.101(d), 211.122, 211.186, 211.188(b)(11), 212.50(c)(10) |
| Legible | Readable and permanent | 211.180(e), 212.110(b) |
| Contemporaneous | Recorded at the time of performance | 211.100(b), 211.160(a) |
| Original or true copy | First capture, or a verified copy | 211.180, 211.194(a) |
| Accurate | Correct and checked | 211.22(a), 211.68, 211.188, 212.60(g) |
02All nine attributes in practice
MHRA §3.10 says ALCOA was historically regarded as defining data quality suitable for regulatory purposes and the '+' was added to emphasise the requirements; there is no difference in expectations whichever acronym is used. MHRA §6.1 gives the meanings below. The 'What to look for' column is practical interpretation, not regulatory text.
| Attribute | MHRA §6.1 meaning | What to look for |
|---|---|---|
| Attributable | Attributable to the person generating the data | Individual accounts; automated entries traced to their source device |
| Legible | Legible and permanent | Readable for the whole retention period; corrections leave the original visible |
| Contemporaneous | Recorded at the time of the activity | Time stamps from a controlled clock; no end-of-shift entry |
| Original | Original record (or certified true copy) | First capture kept; dynamic records kept dynamic |
| Accurate | Accurate | Checks, calibrated instruments, reviewed calculations |
| Complete | The data must be whole; a complete set | Repeats, failures and metadata kept, not just the passing result |
| Consistent | The data must be self-consistent | Dates, sequences and units agree across the record |
| Enduring | Durable; lasting throughout the data lifecycle | Backups and archives that can still be read |
| Available | Readily available for review or inspection purposes | Retrievable in human-readable form when asked |
MHRA §§6.5–6.6 places these within data governance across the whole lifecycle — generation, processing, use, retention, archive and destruction — with senior management accountable and staff trained to report errors and omissions.
03Original records, true copies and printouts
A printout is not automatically invalid. FDA's 2018 Q&A Q10 says a paper printout or static record may satisfy retention requirements if it is the original record or a true copy — for example from a pH meter or balance that creates a printout as the original. MHRA §6.2 agrees: for basic equipment that stores no electronic data, the printout is the raw data.
Dynamic records are different. Q10 says some instrument records — FDA's example is an FT-IR spectral file that can be reprocessed — are dynamic, and a static printout does not preserve the complete original. Q9 says electronic true copies are acceptable if they preserve the content and meaning of the original, including metadata and its static or dynamic nature. MHRA §6.2 says information captured in a dynamic state should remain available in that state.
04Worked example
- Attributable: a weight is captured under the operator's own login, not a shared account.
- Contemporaneous: the weight is recorded when weighed, not at shift end.
- Original: the balance reading is captured directly, so no transcription.
- Accurate: an out-of-tolerance weight is flagged for a person to act on, not overwritten.
- Complete: a repeat weighing keeps both readings and the reason, not only the last one.
- Enduring and available: the record and its audit trail can still be retrieved and read at inspection years later.
05Where ALCOA breaks
- Backdated entries or pre-filled forms.
- Corrections that obscure the original value.
- Unverified 'true copies' of electronic data.
- Signatures applied by someone other than the performer.
06Questions to ask a system supplier
- Which entries are captured directly from instruments, and how is the source device recorded?
- When a value is corrected, can a reviewer see the original, the new value, who changed it and why?
- Are failed and repeated results kept alongside the accepted one?
- How are records exported as true copies, with their metadata, for inspection?
- How long can archived records be retrieved and read, and who tests that?
07Where V5 fits
V5 lists an immutable audit trail (ALCOA+), direct device capture from paired scales, and Part 11 e-signatures. Customers decide which records and processes are in scope, write the procedures and approve the outcomes; using V5 does not by itself establish compliance or a validated state. IQ/OQ documentation and validation support are offered on the Enterprise plan; the customer performs PQ and owns validation and approvals.
Frequently asked questions
Q.Is ALCOA+ in the CFR?+
No. The CFR contains the underlying requirements. FDA's 2018 Q&A uses ALCOA; MHRA's 2018 guidance (§3.10) defines the '+' as complete, consistent, enduring and available.
Q.Does ALCOA apply to paper records?+
Yes. The attributes apply to CGMP data whatever the medium.
Q.Is a paper printout ever acceptable as the record?+
Yes, when it is the original record or a true copy — for example from a balance that only prints. It is not enough for dynamic records, such as reprocessable instrument files (FDA 2018 Q&A Q10).
Q.What does contemporaneous mean?+
Recorded at the time the activity is performed, as 21 CFR 211.100(b) requires for production and process control.
Q.Can software make records ALCOA+ on its own?+
No. Controls help, but procedures, training and people's review determine whether records are trustworthy.
Primary sources
Further reading
Explore this topic
ALCOA+ sits inside 2 overlapping topic clusters in our glossary. Every neighbour is one click away.
Electronic records, signatures, audit trail and ALCOA+ data-integrity principles.
HCT/Ps, blood cGMP, donor eligibility, ISBT 128 labeling and forward-tracing lookback.
Want to see how ALCOA+ could fit into your own records and workflows? Explore the related V5 pages or talk to our team about what applies to your operation.