Industries
Pharmaceuticals & Life Sciences
Electronic batch records, serialisation and Part 11-ready traceability for GMP manufacturing.
Overview
In regulated manufacturing every batch must be made right first time, and the records must prove it. We help pharmaceutical and life sciences manufacturers digitise batch execution, weighing and dispensing, and genealogy, with the validation evidence auditors expect.
Our GAMP + Agile methodology builds compliance into every project, from requirements through qualification, and LogiCare keeps validated systems in a controlled state after go-live.
Challenges we help solve
- Paper batch records that slow down review and release
- Data integrity expectations under 21 CFR Part 11, EU Annex 11 and ALCOA+
- Serialisation and end-to-end traceability
- Validation effort for every change to a computerised system
Solutions
Applications for Pharmaceuticals & Life Sciences
eBRElectronic Batch RecordsGuided, paperless batch execution with electronic signatures, review-by-exception and complete batch genealogy for regulated manufacturing.Explore eBR
WDWeigh & DispenseGuided, right-first-time weighing with barcode and scale compliance checks, electronic records and signatures, and review-by-exception.Explore WD
RMRecipe ManagementISA-88 recipe management with automated setpoint download to PLCs, real-time deviation monitoring and 21 CFR Part 11 e-signatures.Explore RM
TXGTraceability & GenealogyLive product genealogy from raw materials to finished goods, with serialisation, labelling, audit trails and mock recalls in minutes.Explore TXG
QMSQuality Management SystemDocument control, CAPA, audits, training, risk management and full LIMS in one plant-floor-connected platform for regulatory compliance.Explore QMS
RCSRegulatory Compliance & SustainabilityValidated systems and trustworthy records for regulators, plus measured energy, emissions, water and waste data you can report with confidence.Explore RCS
LMSLabel Management SystemCentralised label design, template governance and print orchestration on Ignition, with GS1 barcodes, SSCC generation and multi-site template sync.Explore LMS
AVIAutomated Visual InspectionAI visual inspection at line speed: defects found and rejected in real time, with every image and result linked to the batch and shared with quality, SPC and OEE.Explore AVI
OTSOperator Training & SimulationOperators train on their own control screens against a dynamic model of your process, in the control room and in virtual reality, with every exercise scored and recorded.Explore OTS
Services
How we deliver
Working in Pharmaceuticals & Life Sciences?
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