Laboratory
Results originate in the system, and so does the OOS.
Analytical results are captured in the system and evaluated against a frozen specification. An out-of-specification result opens the investigation in quality, and a batch without approved results can’t be released.
What it does
From sample to certificate, without transcription.
The sample is the unit of work, the versioned specification is the rule, and second-person review stands behind every result.
Methods and samples
- Versioned analytical methods with signed approval
- Specifications by product and stage, with a single effective version
- Sampling plans that create samples from the production order
- Barcode labels, sample receipt and chain of custody
Results
- Keyboard-friendly worksheet with automatic evaluation against limits
- Second-person review and signed approval
- Changing a result requires a reason
- Calculation formulas that store the variables used
- Instrument file import with preview and duplicate blocking
Certificates and stability
- Signed certificate of analysis; not issued while tests are pending
- Stability studies with time points and tolerance windows
- Upcoming and overdue window alerts, trends and shelf-life estimation
A lab in order
- Inventory of reagents, standards and columns with effective expiry
- Solutions traceable to their source reagent
- Daily instrument use checks
Connected
It shares the record with the rest of the suite.
Modules aren’t integrated through exports: they work on the same batch data.
The OOS is investigated in quality, and analytical status drives batch release.
MTMaterialsThe certificate of analysis is required to approve a material lot.
EQEquipmentEach instrument’s calibration status comes from the equipment module.
PXSupplier and contract client portalContract manufacturing clients see analytical status and the certificate for their batches.
Compliance
Regulations it supports.
Electronic signatures and the audit trail are the same across the suite.
See the compliance matrix- 21 CFR 211 subpart I · 211.194
- Laboratory testing and laboratory records.
- FDA OOS guidance (2022)
- Laboratory-phase and manufacturing-phase investigation.
- ICH Q2(R2) · Q1A(R2) · Q1E
- Analytical procedures, stability testing and shelf-life estimation.
- USP <1058>
- Analytical instruments fit for intended use.
- 21 CFR Part 11 · ALCOA+
- E-signatures, audit trail and data integrity.
Watch an OOS open without anyone copying it.
We’ll walk you through the module with a case like yours and show how it connects to what you already use.