Pharmaceuticals & biotech

GMP and GLP equipment held to its qualification state, with the site licences, controlled-substance registrations and instrument qualifications that expire whether or not anything changed.

Ships today as the pharma pack, version 1GMP · GLP · Annex 1

Document type: Industry pack
Document: ACT-WEB

What the pack gives you on day one.

GMP and GLP equipment under qualification, with the site licences, controlled-substance registrations and instrument qualifications that lapse on a calendar date. Everything below is seeded into your organisation when you adopt the pack, and every row of it is yours from that moment: rename it, reorder it, delete it, add to it. Upgrading the pack later never overwrites something you have edited.

Instruments you put in the register

Analytical instrument: HPLC, GC, MS and spectrometers producing data that supports a release decision.
Bioreactor: Fermenters and single-use systems in the process train.
Cold storage: Freezers, fridges and cryogenic stores with mapped temperature ranges.
Cleanroom system: HVAC, LAF cabinets and isolators holding a classified grade.
Water system: Purified water and WFI loops under continuous monitoring.
Autoclave & depyrogenation: Sterilisers and dry-heat tunnels with cycle validation.
Fill & finish: Filling lines, lyophilisers, capping and inspection.
Balance & metrology: Balances, pipettes and reference standards on a calibration interval.

Fields your sector needs

Not hardcoded into the product for everyone — defined by the pack, validated on every write, and filterable and exportable like any built-in field.

GxP impactOne of a listrequired: Direct-impact equipment is qualified; indirect and no-impact are maintained under good engineering practice.; Direct impact · Indirect impact · No impact
Qualification stateOne of a list: DQ complete · IQ complete · OQ complete · PQ complete · Requalification due · Decommissioned
Cleanroom gradeOne of a list: The graded area this sits in, under Annex 1.; Grade A · Grade B · Grade C · Grade D · Unclassified
Part 11 relevantYes / no: Creates or holds electronic records subject to Part 11 or Annex 11.
Controlled substance storeYes / no: Holds scheduled substances, so the registration behind it must stay current.

Your words, not ours

No screen in the product hardcodes a noun. The pack renames these, and the rest keep the neutral word.

assetInstruments
entitlementQualifications
maintenance_planRequalification schedules
service_eventQualification records
locationRooms

What expires, and how early you hear about it.

These are the real warning ladders, not an illustration. Each one is set from how long that renewal actually takes — a certificate an authority re-inspects opens months ahead, because a thirty-day reminder would already be too late. The first rung is when the work has to start; a final 1 means it stops work the day it lapses.

Qualifications the Pharmaceuticals & biotech pack seeds, with their default warning thresholds
Qualification	Why it is on the ladder	Warns at
Manufacturing licence	Site authorisation from the medicines regulator. A variation takes longer than a renewal.	3651809030days before
GMP certificate	Issued after inspection and valid for a fixed term.	2701809030days before
Controlled substance registration	Licence to hold scheduled substances. Lapsing means the safe is illegal, not merely non-compliant.	180903071days before
Equipment qualification	IQ/OQ/PQ, and the periodic review that keeps it current.	12060307days before
Cleaning validation	—	1206030days before
Calibration certificate	—	603071days before
Cleanroom certification	Classification and recertification of a graded area.	90307days before
Computer system validation	Periodic review of a GxP-relevant system, including the ones a vendor hosts.	1809030days before
Supplier qualification	—	1206030days before
GxP training	Held by a person, and the first thing an inspector samples.	90307days before

Held against

Tag an obligation with the standard it satisfies, and the coverage report counts them — including the ones mapped to no framework at all, which is the number an auditor asks about.

EU GMP Annex 1 · European Commission
EU GMP Annex 11 · European Commission
FDA 21 CFR 211 · US Food and Drug Administration
FDA 21 CFR Part 11 · US Food and Drug Administration
ICH Q7 · ICH
ICH Q9 quality risk management · ICH
GLP · OECD

Views already drawn

Filters your sector asks for weekly, waiting above the register on the first day. They are ordinary saved views: change the columns, delete the ones you do not want, save your own.

Direct-impact instruments
Requalification due
Graded areas
Controlled substance stores

The question the inspection opens on.

“Which instruments were outside their qualification period during this campaign?”
— what an auditor in this sector asks first

The auditor export answers it in one action: the instrument, every obligation on it, every plan, every service event, every filed document and the full change history — assembled in a single consistent read, so no two sections of the file can disagree. Two exports of an unchanged record are byte-for-byte identical.

Append-only history. Every change lands in an event log in the same transaction as the change. No role holds an update or delete grant on that table.
Certificates listed, with their evidence. Documents filed against the obligations and the service events are in the export too — the calibration certificate lives on the service event, and that is the one you will be asked for.
Readable by everyone on the team. Quality, finance and an external auditor given a seat can all run it. The people who most need the export are exactly the ones a viewer role would have blocked.

The dashboard on any Monday morning: what has already lapsed, what lapses this week, and what needs starting now to land on time.

Northfield LabsRegisterSample data11 Apr · Europe/London

Overdue

Due this week

Next 30 days

Renewals to start

Failed sends

Sample obligations from a fictional organisation, resolved against an observation date the visitor controls. Every row is one record in the register — an obligation, the asset it sits on, and the person accountable for it.
Obligation	Asset	Location	Date	Status	Owner
Sterilisation validation8 Apr	Autoclave AC-114	Plant 1 · Clean room	8 Apr	3d overdue	R. Mensah
Storage permit15 Apr	Solvent store SS-02	Plant 2 · Yard	15 Apr	in 4d	A. Silva
Calibration certificate17 Apr	CMM-07	Plant 1 · Metrology	17 Apr	in 6d	J. Park
ISO 13485 certificate4 Jul	Organisation-wide	All sites	4 Jul	open · 84d	Quality
Service contract25 Apr	Cold room CR-1	Plant 2 · Store	25 Apr	cancel in 14d	Finance
Pressure vessel inspection3 Apr	Autoclave AC-114	Plant 1 · Clean room	3 Apr	8d overdue	R. Mensah
Radiation source licence12 May	X-ray cabinet XC-3	Plant 1 · Inspection	12 May	open · 31d	H. Okonjo
Torque wrench calibration20 Apr	TW-221	Plant 1 · Assembly	20 Apr	open · 9d	J. Park
Notified-body surveillance6 Jun	Organisation-wide	All sites	6 Jun	open · 56d	Quality
Cleanroom classification2 May	Clean room CR-A	Plant 1 · Clean room	2 May	open · 21d	R. Mensah
Forklift operator ticket10 Apr	Forklift FL-06	Plant 2 · Yard	10 Apr	1d overdue	A. Silva
Balance verification8 May	Analytical balance AB-2	Plant 1 · Metrology	8 May	in 27d	J. Park

Bring us your pharmaceuticals spreadsheet.

The first session is the import: a column mapper, a dry run that shows exactly what will be created, a per-row error report numbered to match your file, and an undo for the whole batch in one action. Getting five hundred rows in on day one is the point, not a later project.

Programme: Pilot
Places: Limited
Reply: Every enquiry

Request a pilot

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