About EngSci
EngSci is a management consulting firm specialized in digital transformation of AI and information systems—strategy, governance, and delivery—across regulated and high‑reliability industries. We help Biotech & Pharma and broader Life Sciences organizations implement and validate computerized systems and data/AI platforms. We also support Finance & FinTech in addition to laboratories in Oil & Gas, Environmental, and Food & Beverage sectors.
Expertise
- Digital transformation management: strategy, roadmap, operating model, PMO, change management
- Enterprise architecture, systems integration, and data management (MDM, lineage, governance)
- CSV for AI, LIMS, ELN, QMS/eQMS, ERP/MES, data platforms (life sciences + adjacent industries)
- Life sciences compliance: GxP, 21 CFR Part 11, EU Annex 11, Data Integrity (ALCOA+), ICH Q9(R1)
- Finance & FinTech assurance: SOC 2 / ISO 27001 alignment, SOX/GLBA/FFIEC considerations, secure SDLC
- Laboratory & instrument lifecycle: DQ/IQ/OQ/PQ, AIQ (USP <1058>), calibration & metrology
- Audits, inspection readiness, training, and vendor/supplier qualification