00Glossary

Words we use, and why.

Every established tool in this market coined its own noun for the batch-context object. We did not. Where the regulation has a word, we use the regulation’s word; where it has none, we use the plain word a reviewer already says. Each entry names its source.

01The record

Assembly, sources, layers, one axis.

  1. assembled record, assembleThe production record of one batch, assembled from every system that touched it and registered to one time axis, read in place. The assembly is the three weeks; the software makes it the software’s job. Purpose word from FDA: records must let you “reconstruct the CGMP activity” (Data Integrity Q&A, 2018).
  2. sourceOne system of record that holds part of the batch: historian, SCADA, MES, LIMS, ERP, BMS. A source is never copied and never written to by the review layer.
  3. layerOne source’s contribution to the assembled record: trend, alarms and events, phases, limits and bands, genealogy, room conditions.
  4. axisThe single time axis every layer is registered to. One batch, one axis.
  5. registration, read in placePlacing a layer on the axis without changing it. The imaging word for aligning without transforming, which is the read-only claim stated precisely.

02Time

Windows, phases, percent of run.

  1. windowAny bounded stretch of the axis with a start, an end and the layers it touched: a batch window, a phase window, an excursion window, an alarm window, a room event window. Windows are searched by name and attribute, not by scrolling time. Drag on the demo’s trend to make one and read it across every CPP. Plain English; other tools coin a term for the same object.
  2. time zero per phaseComparing windows of the same type with the clock restarted at each ISA-88 phase boundary, so phases of different length line up. The phase boundaries come from the recipe system.
  3. percent of runThe alignment the public demo uses, because its dataset has no phase column. Always stated as a concession, never hidden.

03Exceptions

The regulator’s words for review by exception.

  1. exception reportThe list Batch at a Glance opens with: every predetermined abnormal value, event or action for this batch, raised by rules before the reviewer reads anything else. MHRA’s term and definition: “a validated search tool that identifies and documents predetermined ‘abnormal’ data or actions, that require further attention or investigation by the data reviewer” (GxP Data Integrity Guidance, 2018, 6.13).
  2. exceptionOne line on the exception report. Types: excursion (a trend leaves the band or a limit), yield exception (theoretical yield outside its established range, §211.192’s own example), result exception (OOS or OOT from the LIMS), event exception (an alarm or operator action), room exception (BMS outside its range).
  3. ruleThe predetermined test that raises an exception: a band, a limit, a yield range, an alarm class, a room range. Rules are versioned and the version that fired is stored on the exception.
  4. discrepancyAn exception the reviewer has taken up. Its states are §211.192’s own: flagged, in review, explained, unexplained, investigation opened. Explained requires a note. Unexplained is the regulatory trigger and hands off to the QMS with a reference. Never closed, resolved or approved: those are dispositions, and the quality control unit owns them.
  5. extend“The investigation shall extend to other batches of the same drug product” (§211.192). The control runs the same rule across every other batch of the product and lists where the departure recurs.
  6. investigation recordWhat “investigation opened” creates in the demo: the written record §211.192 requires, with the trigger, the related batches, the notes, conclusions and follow-up (the regulation’s two named fields), and an external reference once exported. Its states are open, conclusions recorded, exported. It is never closed in encompass360; the QMS closes it.
  7. export adapterIn the demo, the API that posts an investigation record to the system that owns tickets, with the ticket id and URL written back. Shown as a design; production targets are agreed per site.
  8. excursion, deviation, OOS, OOTAn excursion is a trend departure. A deviation is a documented departure from a written procedure (§211.100). OOS is a result against a specification; OOT is a result against its own history. They are four different things.

04Golden master

A population, not a favourite run.

  1. golden masterThe reference trajectory for a product code, computed from the reference population of released batches over a stated training window, shown as a median with a band (5th to 95th percentile by default). Never a single hand-picked batch.
  2. departure, area outHow far and for how long a trace left the band. Area out weighs a long shallow drift above a one-sample spike, which is the order a reviewer wants.

05What the reviewer writes

Note, pin, seal.

  1. noteAn attributable, time-stamped entry on a window, an exception or a discrepancy, with a reason and an optional attachment. MHRA: the audit trail should hold “the who, what, when and why of the action.”
  2. pinCapture the review exactly as displayed: windows, values, band and its training window, rule versions, source versions and notes, hashed, so it reads the same in five years. A pin is unsigned and can be superseded. FDA distinguishes a static from a dynamic record; a pin is the static record of a dynamic review.
  3. sealSign a pinned review. A seal applies the reviewer’s electronic signature to the pin, links signature to record (21 CFR §11.70) and locks it; a sealed review is never edited, only superseded by a new sealed review that references it (EU GMP Annex 11, §14). States of a review: draft, pinned, sealed, superseded.
  4. second person reviewA second reviewer’s seal on the same pin. FDA uses the phrase; Annex 11 §6 allows the check “by a second operator or by validated electronic means.”

06Audit trails

Two of them.

  1. source audit trailThe audit trail each source keeps, read in place and shown on the axis beside the value it changed. FDA: reviewers “should review the audit trails that capture changes to data associated with the record as they review the rest of the record.”
  2. review audit trailencompass360’s own: what was done in the review layer, by whom and when. The objects it covers and the ones it deliberately excludes are stated on Data matters.
  3. changed since original entryThe report Annex 11 §8.2 asks for by name: printouts “indicating if any of the data has been changed since the original entry.” Report family 10.

07Words we do not use

And what we say instead.

  1. statusA batch is dispositioned; a discrepancy has a state.
  2. golden batchGolden master: a population, not a run.
  3. event frame, capsule, fingerprint, context itemOther vendors’ coined terms. Ours is window.
  4. closed, resolved, approvedExplained, unexplained, investigation opened. Disposition belongs to the quality control unit.
  5. validated equipmentEquipment is qualified (IQ, OQ, PQ); processes and computerised systems are validated.
  6. GAMP 5 compliantGAMP governs how the customer validates. It is not a property of a product.
  7. single pane of glass, digital twin, AI-poweredThe assembled record, and descriptive statistics where they are descriptive statistics.
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