Industry challenges we solve
Life sciences teams rarely struggle to describe what the software should do. They struggle to get it built, validated and kept in a validated state without every change turning into a months long project.
Validation that costs more than the build. Every small change triggers a full regression of manual scripted tests and a stack of paper. Teams stop improving systems because re-validation is too painful.
Instrument data copied by hand. Results from chromatography systems, balances and plate readers are transcribed into the LIMS or a spreadsheet, creating exactly the data integrity gaps ALCOA+ is meant to prevent.
Audit trails that do not tell the story. The system logs that a record changed, but not who changed it, what the old value was or why. Inspectors notice, and the remediation becomes a 483 response.
Clinical data spread across vendors. EDC, ePRO, IRT, labs and the CTMS each hold part of the picture. Reconciling them for a data review or a database lock takes weeks of manual work.
Safety case intake by email. Adverse event reports arrive from call centres, literature, partners and social channels in different formats, and the clock for expedited reporting starts on the day of receipt.
Serialization data that does not reconcile. Packaging lines, the level 4 site server, the enterprise repository and trading partners disagree on what was commissioned and shipped, and exceptions pile up at the dock.