Pharmaceutical software carries obligations most business systems do not. Records must be attributable, legible, contemporaneous, original and accurate; systems touching quality-critical processes are expected to be validated; and an inspector may ask you to demonstrate the audit trail for a specific batch produced two years ago.
We build pharmaceutical systems with those expectations designed in rather than retrofitted after an audit finding.
Data integrity
ALCOA+ principles are structural in how we build. Every record carries an attributable user identity, records are created at the time of the activity rather than back-filled, original entries are never overwritten — corrections are made as new versions with reason capture — and the complete history remains available.
Audit trails are non-deletable and independently reviewable, and system clocks are synchronised so contemporaneous means what it claims to mean.
Manufacturing and quality
Electronic batch records with stage-wise capture and review-by-exception, in-process quality checks with specification limits enforced at entry, deviation recording with investigation workflow, change control, and CAPA management tracked to closure.
Specification enforcement at the point of entry is important: a system that accepts an out-of-specification value without challenge produces records that look compliant and are not.
Serialisation and track-and-trace
Serialisation requirements vary by market and continue to evolve. We build unique identifier generation and management, aggregation through the packaging hierarchy from unit to case to pallet, and reporting to the relevant regulatory portals — including India's requirements for exported drug formulations.
The practical requirement is that a serial number can be resolved to its full production and distribution history quickly.
Distribution
Batch and expiry tracking through the distribution chain, FEFO allocation so shorter-dated stock moves first, cold chain monitoring with excursion alerting where products require it, and recall management capable of identifying affected stock positions rapidly.
Validation
Systems intended for regulated use need validation documentation — user requirement specifications, functional and design specifications, and installation, operational and performance qualification protocols with executed evidence.
We produce this documentation as part of delivery and support your quality team through validation. We are explicit that the validated state belongs to you: it depends on your procedures and your executed protocols, not on a vendor claim of compliance.