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.
| 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?”
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.
| 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.
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