All evidence in one system. Every module knows the others

DQ, IQ, OQ, PQ for equipment and lines

Every plan starts from a template for the equipment type: tests, parameters, acceptance criteria, measuring points. You adapt it; the system records which template version it is based on.

• Templates for sterilisers, washer-disinfectors, injection moulding, laser, CNC, cleanroom monitoring, test machines, laboratory instruments, pharmaceutical equipment
• Lines with members, requalification by plan copy, worst-case selection via rating matrix
• Sampling decision per test condition, documented with justification

Product, process, equipment: one validation plan

Validation plans link product and process with the equipment it runs on. OQ and PQ validation with Cpk and Ppk as acceptance criteria, process windows with limits; requalification is triggered when a window is violated.

• Templates for cleaning validation, packaging, seal, shelf life, sterilisation load
• Risk assessment per ISO 14971 as input; test items are derived from process risks
• Validation portfolio as an overview of all products and processes

CSV per GAMP 5, no blank page

Inventory systems, set the GAMP category, adopt the standard test catalogue, import requirements, execute test cases. The traceability matrix builds itself and exports as PDF and CSV.

• Cumulative test catalogue per category 1, 3, 4 and 5
• A failed test case automatically raises a deviation
• Revalidation as a successor plan referencing its predecessor

MSA studies per AIAG, evaluated in the system

Type 1 (Cg, Cgk), type 2 and 3 (gage R&R by ANOVA, %GRR, ndc) and type 7 (attribute, kappa). Randomised measurement order, part references, measurement import, verdict with justification.

• Evaluation per AIAG MSA 4th edition and Bosch booklet 10
• Studies stored with the instrument as proof of measurement capability

ISO 14644-1 does the maths

Enter cleanroom, occupancy state, area and flow rate. Minimum number of sampling locations, single sample volume and sampling time come from the standard, not from a table in an appendix. Compressed air is assessed per ISO 8573-1.

A calibration status that has consequences

Instruments with parameters, measuring range, units and certificates. Status valid, due soon, overdue with reminders to the responsible person. And the consequence: in every execution, only a suitable, validly calibrated instrument may deliver the measurement.

Deviations are recorded automatically

A value outside the limits, a failed test case, an instrument with special approval: the deviation is created at the moment of entry, linked to measurement, inspector and time. CAPA with its own numbering, change control with impact assessment and four-eyes approval.

12 report types, one click

Qualification plan and report, validation plan and report, traceability matrix, deviation report, risk file, DQ report, FAT/SAT protocol and more. As PDF/A with signature pages, with your logo and your document numbers. Reproducible identically from the same data.

• Two separate audit trails: business and system
• Review notes per EU GMP Annex 11 §9 with proof of independence

Proposals with source reference, decisions by people

Upload the manual, specification or URS as PDF. The assistant proposes tests with criterion, expected result and phase and shows the source location in the document for each proposal. Only what a person confirms is adopted. Can be disabled per tenant; processing only with consent.

Measurements from the machine, not from a slip of paper

Import from CSV and AQDEF (Q-DAS) with saved profiles and preview; every source file is stored with a checksum. Machines and test rigs send measurements directly via a secured interface.