A sector where process control and repeatability are critical.
The pharmaceutical and cosmetics industry is one of the most regulated sectors in the global economy. Manufacturing medicines, medical devices or cosmetics subject to marketing authorisation (MA) requires perfectly controlled, reproducible and documented processes. Every production parameter — temperature, humidity, pressure, cycle time — must be measured, recorded and demonstrable during regulatory audits (FDA, ANSM, EMA).
AUTOM Technologies brings to this sector technical expertise in automation and industrial IT, combined with a thorough understanding of GMP/cGMP regulatory requirements. We design systems that do not merely function: they trace, document and enable pharmaceutical validation.
How we operate
Automation of equipment and critical utilities
We automate production equipment and critical utilities at pharmaceutical and cosmetics sites: air handling units (AHU), cleanroom HVAC systems, purified water generators (WFI, PW), autoclaves, reactors, blenders and washing systems. For each piece of equipment, we define critical control loops (cascade PID, flow regulation), safety alarms and thresholds, as well as the required regulatory records.
PLC programming, supervision and recipe management
Our developments integrate production recipe management (ISA-88 batch logic), documented automatic and manual operating modes and operator interfaces compliant with GMP ergonomic requirements. Supervision systems (SCADA/DCS) continuously collect and archive critical process parameters: temperature, relative humidity, room differential pressure, particle counts, air and fluid flow rates.
Validation documentation (DQ, IQ, OQ, PQ)
Validation is a central requirement of the pharmaceutical sector. Our deliverables include the required qualification documentation: Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ). We produce these documents according to the GAMP 5 framework and regulatory authority expectations, with complete traceability between User Requirement Specifications (URS), design and validation tests.
Data integrity and 21 CFR Part 11
FDA 21 CFR Part 11 regulations and ALCOA+ guidelines impose strict requirements on the integrity of electronic data: audit trails, access rights management, electronic signatures, secure backup and archiving. Our supervision systems are configured to meet these requirements: immutable event logs, granular user profile management and compatibility with pharmaceutical document management systems.
Standards and regulatory frameworks
- GMP / cGMP (Good Manufacturing Practice) — Pharmaceutical regulatory frameworks applicable to production equipment
- FDA 21 CFR Part 11 — Electronic records and signatures: data integrity, audit trail, access rights
- GAMP 5 — Guide for computer system validation in the pharmaceutical industry (ISPE)
- ISA-88 (IEC 61512) — Batch process control: recipe management, modes, equipment
- ISO 14644 — Classification of cleanrooms and controlled environments
- ALCOA+ — Data integrity principles (Attributable, Legible, Contemporaneous, Original, Accurate)
Representative project
Air Handling Unit (AHU) — Pharmaceutical site
Complete automation of an air handling unit for an ISO 7 pharmaceutical production cleanroom: regulation of temperature, relative humidity and differential pressure between zones, management of fresh and recirculated air flow rates, particle count monitoring. Full qualification documentation (DQ/IQ/OQ) prepared in compliance with GMP requirements and submitted for approval by the site quality manager.
Do you have a Pharmaceutical or Cosmetics project?
Our engineers understand the specific challenges of the pharmaceutical sector: validation requirements, data integrity, regulatory documentation. We support you from design through to qualification, ensuring your automated systems comply with GMP, cGMP and FDA requirements.