This is a ready-to-use, one-page style quick-reference card: the acronyms a GxP, CSV, or data integrity professional hears daily, each with a one-line expansion and the reason it matters. Post it at a desk, hand it to a new hire, or keep it open in a second tab during a call. It is a condensed lookup, not a substitute for the full definitions, worked examples, and comparison tables in The GxP, CSV, and Data Integrity Glossary; use that article when you need the reasoning behind an entry. Replace the <<FILL: ...>> placeholders with your own specifics. A filled specimen follows. Verify each acronym and citation against the current source before you rely on it, especially anything tied to a guidance or regulation that has been revised recently.
Header
| Field | Entry |
|---|---|
| Card title | GxP / CSV / Data Integrity Acronym Quick-Reference Card |
| Owner / function | <<FILL: role or team, e.g. Validation Training Lead>> |
| Site(s) applicable | <<FILL>> |
| Version | <<FILL>> |
| Last verified against current guidance | <<FILL: date>> |
| Next verification due | <<FILL: date>> |
| Posting / distribution location | <<FILL: e.g. QC lab wall, new-hire packet, intranet page>> |
1. How to use this card
Scan by category. If a one-liner is not enough to answer the question in front of you, follow the acronym to its full entry in the glossary article, which carries the regulation, a worked example, and, for the terms people mix up, a comparison table. Treat the “why it matters” column as the test of whether you actually know the term: if you cannot restate it in your own words, you are recognizing the acronym, not using it.
2. Core GxP family
| Acronym | Stands for | Why it matters |
|---|---|---|
| GxP | Good “x” Practice | Umbrella term; the GxP determination is what triggers validation, Part 11, and DI requirements at all |
| GMP / cGMP | (current) Good Manufacturing Practice | 21 CFR 210/211 (US), EudraLex Volume 4 (EU) |
| GLP | Good Laboratory Practice | 21 CFR Part 58; nonclinical safety studies, not routine QC testing |
| GCP | Good Clinical Practice | ICH E6(R3); protects subjects and produces credible trial data |
| GDP | Good Distribution Practice | Storage, transport, and cold-chain integrity through the supply chain |
| GVP / GPvP | Good Pharmacovigilance Practice | Post-market safety data collection and assessment |
| GDocP | Good Documentation Practice | Turns ALCOA+ principles into how you actually fill in a record |
3. Data integrity core
| Acronym | Stands for | Why it matters |
|---|---|---|
| DI | Data Integrity | Records trustworthy enough to base a quality decision on |
| ALCOA | Attributable, Legible, Contemporaneous, Original, Accurate | The original five record attributes |
| ALCOA+ | + Complete, Consistent, Enduring, Available | The nine-attribute standard cited by inspectors today |
| True copy | Meaning-plus-metadata preserved copy | US/Part 11 vocabulary for a defensible copy of an original |
| Certified copy | Signed-confirmation preserved copy | UK/EU vocabulary for the same underlying control |
| Metadata | Data about data | Without it, a number is not a complete record |
4. Part 11, Annex 11, and records
| Acronym | Stands for | Why it matters |
|---|---|---|
| Part 11 | 21 CFR Part 11 | US electronic records and signatures rule, in force since 1997 |
| Annex 11 | EU GMP Annex 11 | EU computerised systems annex; covers the whole system lifecycle |
| e-signature | Electronic signature | Must carry name, date, meaning, and be permanently linked to its record |
| Open / closed system | Access-control boundary | Drives which Part 11 controls (like encryption) you owe |
| Hybrid system | Paper plus electronic mix | High risk; the paper-to-electronic link is procedural, not technical |
5. CSV, CSA, and QMSR
| Acronym | Stands for | Why it matters |
|---|---|---|
| CSV | Computer System Validation | Documented evidence a computerized system does what it should |
| CSA | Computer Software Assurance | FDA guidance scoped to 21 CFR 820.70(i); finalized 24 Sep 2025, retitled ”…Quality Management System Software” 3 Feb 2026 |
| QMSR | Quality Management System Regulation | 21 CFR 820 amendment incorporating ISO 13485:2016; effective 2 Feb 2026; records control now at 820.35 |
| GAMP 5 | Good Automated Manufacturing Practice, 2nd ed. | The de facto industry method for CSV; introduces the category model |
| V-model | Validation lifecycle shape | Requirements descend, verification activities ascend, traceable pairwise |
6. Requirements, specs, and qualification
| Acronym | Stands for | Why it matters |
|---|---|---|
| URS | User Requirement Specification | The anchor of the traceability chain; must be testable |
| FS / FRS | Functional (Requirements) Specification | How the system meets each URS item |
| DS / DDS | Design Specification | The technical “how it is built” |
| RTM | Requirements Traceability Matrix | Proves every requirement is tested and every test traces back |
| DQ | Design Qualification | Design meets user requirements, before build or purchase |
| IQ | Installation Qualification | Installed correctly per specification |
| OQ | Operational Qualification | Functions correctly across the operating range |
| PQ | Performance Qualification | Reliable in real use; traces back to the URS |
| FAT / SAT | Factory / Site Acceptance Test | Vendor-side and customer-side acceptance testing |
| VSR | Validation Summary Report | Releases the system for GxP use |
7. Operating the validated system
| Acronym | Stands for | Why it matters |
|---|---|---|
| Change control | Formal pre-change assessment process | Approval happens before the change, not after |
| Config mgmt | Configuration management | The record of the exact current baseline; needed for change impact |
| RBAC | Role-Based Access Control | Enforces segregation of duties |
| DR | Disaster Recovery | Inspectors want a tested restore, not just a backup schedule |
| Periodic review | Scheduled system re-evaluation | Confirms still validated, still controlled, still fit for use |
8. Systems by acronym
| Acronym | Stands for | Why it matters |
|---|---|---|
| LIMS | Laboratory Information Management System | QC samples, specs, and results; audit trail on result changes |
| CDS | Chromatography Data System | The single most cited system type in DI warning letters |
| MES / EBR | Manufacturing Execution System / Electronic Batch Record | Enforces the recipe and captures the batch record electronically |
| SCADA / DCS / PLC / HMI | Process automation layers | Who can change setpoints and how alarms are handled |
| ERP | Enterprise Resource Planning | GxP-relevant where it holds genealogy or disposition data |
| EDMS | Electronic Document Management System | Controls SOPs and quality documents |
| CTMS / EDC / eTMF | Clinical Trial Management System / Electronic Data Capture / electronic Trial Master File | Clinical-side systems for trial data and essential documents |
9. Quality system and investigations
| Acronym | Stands for | Why it matters |
|---|---|---|
| CAPA | Corrective and Preventive Action | Effectiveness must be verified, not assumed |
| RCA | Root Cause Analysis | ”Human error” alone is not a completed RCA |
| OOS / OOT | Out of Specification / Out of Trend | OOS fails an acceptance criterion; OOT is in spec but off-pattern |
| QRM | Quality Risk Management | ICH Q9(R1); tools include FMEA |
| FMEA | Failure Mode and Effects Analysis | Severity times Occurrence times Detectability equals the RPN |
| COA | Certificate of Analysis | Summarizes a batch’s results against specification |
10. Process validation and lab terms
| Acronym | Stands for | Why it matters |
|---|---|---|
| PPQ | Process Performance Qualification | Stage 2 of process validation, the formal validation batches |
| CPV | Continued Process Verification | Stage 3, ongoing monitoring after PPQ |
| QbD | Quality by Design | DoE maps CPPs to CQAs inside a defined design space |
| AIQ | Analytical Instrument Qualification | USP <1058>; Groups A, B, and C scale the qualification effort |
| Cpk | Process capability index | Around 1.33 is a common target relative to specification limits |
11. AI and machine learning
| Acronym | Stands for | Why it matters |
|---|---|---|
| AI / ML | Artificial Intelligence / Machine Learning | ML learns behavior from data rather than fixed, coded rules |
| GMLP | Good Machine Learning Practice | Training data, human oversight, and monitored deployment conditions |
| PCCP | Predetermined Change Control Plan | Pre-agreed path for specific, anticipated model changes such as retraining |
| Model card | Trained-model factsheet | Intended use, performance by subgroup, and known limitations |
| Model drift | Deployed-model performance degradation | Needs scheduled monitoring, not a wait-for-a-complaint posture |
| LLM-as-judge | One LLM scoring another’s output | The judge model itself needs qualification against a human-rated set |
12. Inspection and escalation ladder
| Acronym | Stands for | Why it matters |
|---|---|---|
| 483 | FDA Form 483 | Inspectional observations, handed over at the end of an inspection; not a final finding |
| Untitled Letter | (no formal acronym) | Below a Warning Letter in severity; still requires a written response |
| Warning Letter | (no formal acronym) | Formal notice of significant violations requiring prompt correction |
| Import Alert | (no formal acronym) | Detention without physical examination at the US border |
| Consent Decree | (no formal acronym) | Court-entered, binding injunction; the most severe tool short of prosecution |
13. Currency self-check
Regulatory titles, dates, and section numbers move. Work this section every time you re-verify the card, mark each item, and correct the card body before reposting it.
| # | Item | Ready / Gap / N/A | Note |
|---|---|---|---|
| 13.1 | Confirmed CSA’s current guidance title and issue date against FDA’s guidance search page | <<FILL>> | <<FILL>> |
| 13.2 | Confirmed QMSR’s effective date and that no retired Part 820 subpart number is cited anywhere on this card or in active procedures it feeds | <<FILL>> | <<FILL>> |
| 13.3 | Confirmed the ICH E6 (GCP) revision level cited is the one currently in force | <<FILL>> | <<FILL>> |
| 13.4 | Confirmed Part 11 and Annex 11 references cite correct current clause numbers | <<FILL>> | <<FILL>> |
| 13.5 | Confirmed every acronym on this card is still in active use at <<FILL: site/company>>, not a retired internal term | <<FILL>> | <<FILL>> |
| 13.6 | Confirmed no acronym on this card carries a site-specific meaning that conflicts with the general industry meaning shown here | <<FILL>> | <<FILL>> |
| 13.7 | Card content spot-checked against the source glossary article within the last <<FILL: interval, e.g. 6 months>> | <<FILL>> | <<FILL>> |
Sign-off
| Field | Entry |
|---|---|
| Card owner | <<FILL>> |
| Verified by | <<FILL>> |
| Verification date | <<FILL>> |
| Next verification due | <<FILL>> |
| Posting location confirmed current | <<FILL>> |
References
For full definitions, the regulatory basis, worked examples, and confusion-resolving comparison tables behind every entry on this card, use The GxP, CSV, and Data Integrity Glossary. For a decision tool on commonly confused term pairs, use the Which Term Applies matrix.
Acronym expansions and the dates shown were current when this card was last verified (see header). FDA guidance, EU annexes, and ICH guidelines are revised periodically; confirm any specific date, title, or clause number against the current published source before you rely on it or teach it to someone else.
Filled specimen
One QC laboratory’s card, verified and posted at onboarding.
| Field | Entry |
|---|---|
| Card title | GxP / CSV / Data Integrity Acronym Quick-Reference Card |
| Owner / function | QC Training Lead |
| Site(s) applicable | Cell Culture QC Lab, Building 4 |
| Version | 3.0 |
| Last verified against current guidance | 10 August 2026 |
| Next verification due | 10 February 2027 |
| Posting / distribution location | Laminated card at each analyst bench; PDF in the new-hire onboarding packet |
Currency self-check extract:
| # | Item | Ready / Gap | Note |
|---|---|---|---|
| 13.1 | CSA title and date confirmed | Gap, now Ready | Card still showed the September 2025 title; corrected to the February 2026 “Quality Management System Software” title and date |
| 13.2 | QMSR effective date and 820 numbering confirmed | Ready | Card already showed 2 Feb 2026 and 820.35 for records; no retired subpart numbers found in the card or the two SOPs it feeds |
| 13.5 | Acronyms still in active use at this site | Ready | One retired internal acronym (a legacy LIMS nickname) removed from the card |
The gap the reviewer found (a stale CSA title) is exactly why the currency self-check exists: an acronym card that is not re-verified quietly becomes a source of wrong answers in an interview or, worse, in front of an inspector.
How to adapt this card
- Set the owner, site, version, and posting location in the header.
- Trim or add categories to match what your role actually touches; a clinical-only team may drop section 8’s manufacturing systems and add more of section 6’s clinical systems detail.
- Run the currency self-check on a fixed schedule, not only when someone notices a problem.
- Point any acronym that needs more than one line back to its full entry in The GxP, CSV, and Data Integrity Glossary.
- Re-post the corrected card and record the verification in the sign-off section every time.