Glossary
Industrial automation glossary
Technical terms we use daily on pharma, microtechnology and chemistry sites in French-speaking Switzerland. Concise definitions with project context.
Factory Acceptance Test
FAT
A FAT is the acceptance test at the integrator's workshop, executed before shipping an automated equipment to the client site. It validates that the machine, its controller, its HMI and its sequences function in accordance with the contractual FDS and HDS. We run it following a signed protocol covering I/O testing, production sequences, recipes, alarms, safety interlocks, communications with upstream systems (DCS, MES) and documentary deliverables. In a pharma context, FAT also clears non-conformities before transport, where correction cost is lowest. A well-prepared FAT avoids weeks of drift on site. Since 2020, remote FAT (eFAT) has been accepted by Swissmedic and FDA under conditions of streaming and electronically signed execution.
Site Acceptance Test
SAT
The SAT replays critical functional tests on site after installation and connection to utilities (electricity, compressed air, purified water, steam, process gases). We treat it as the final engineering step before the start of regulatory qualifications (IQ, OQ, PQ). The SAT verifies that nothing shifted during transport, that connections match the as-built drawings, and above all that the equipment integrates correctly into its ecosystem: OT network, central SCADA, MES, LIMS, ERP. In practice, SAT is often where network integration or OT cybersecurity defects undetected at FAT come to surface. A well-prepared SAT takes three to ten days. Poorly prepared, it can stall for several weeks over a single misconfigured firewall or a missing VLAN.
Installation Qualification
IQ
The IQ is the first of the three GMP regulatory qualifications. It demonstrates in a documented way that automated equipment is installed in accordance with specifications, under conditions allowing GMP operation. We execute it through a signed protocol that verifies conformity to as-built P&ID and electrical drawings, component serial numbers and firmware, material certificates for product-contact parts, initial calibrations of critical instruments, connected utilities, on-site documentation, plus the creation of user accounts and the allocation of rights according to the URS-defined matrix. Any deviation is tracked in the site QMS and the IQ is closed only when all gaps are resolved or justified by quality.
Operational Qualification
OQ
The OQ demonstrates through structured tests that automated equipment functions correctly across all operational ranges defined in the URS. We test each sequence (start, normal stop, emergency stop, restart), all recipes, the boundaries of process parameters (temperatures, pressures, flows, times), all alarms with acknowledgment and recording in the audit trail, safety interlocks, degraded modes (loss of communication, loss of power), 21 CFR Part 11 requirements, and batch report generation. It is typically the longest qualification phase, between three and eight weeks for a complex line. A good ISA-88 architecture drastically reduces OQ duration because phases run independently, without code recompilation or redeployment.
Performance Qualification
PQ
The PQ demonstrates that equipment, in its real environment, with its final product and trained personnel, produces reproducibly and in accordance with defined quality attributes. We typically execute it over three consecutive batches (or a statistically justified number), varying parameters within the design space boundaries (Design Space ICH Q8). Statistical analyses produced include Cpk, process capability and trend analyses, reviewed by quality. PQ batches can be commercialized if compliant, which rapidly pays back the phase. Once the PQ is approved and the validation report signed, the equipment enters routine operation under Continuous Process Verification (ICH Q8), with continuous monitoring of critical parameters.
Good Manufacturing Practice
GMP
GMP (Good Manufacturing Practice) constitutes the general regulatory framework for pharmaceutical production. In Switzerland, the OAMéd aligns with EU GMP (Eudralex Volume 4), with Annex 11 dedicated to computerized systems and Annex 1 dedicated to sterile products (revised in 2022). We apply these principles to every pharma automation project: equipment qualification, computerized system validation, document management, change control, deviation management, material traceability, personnel training, hygiene and cross-contamination. GMP compliance is audited by Swissmedic for Swiss sites, by FDA for US exports, and by EMA authorities for the European market. A major GMP non-conformity can lead to the suspension of a product's marketing authorization.
GAMP5
GAMP5
GAMP5 (Good Automated Manufacturing Practice, second edition published in 2022 by ISPE) is the reference guide for validating computerized systems in a GMP environment. It structures systems into four criticality categories (from standard OS to custom software) and defines documentation and testing levels proportionate to risk. We systematically use it to frame the validation deliverables of an automation project: GAMP risk analysis, validation plan, URS-FDS-test traceability, change control, retirement plan. The second edition integrates Agile and DevOps approaches, cloud, artificial intelligence and machine learning, which profoundly changes how we validate modern systems (MES SaaS, data platforms, predictive process models) without challenging the fundamental principles of criticality and patient risk.
21 CFR Part 11
21 CFR Part 11
21 CFR Part 11 is the FDA regulation that defines the criteria for electronic records and signatures to be considered equivalent to paper records and signatures. For any pharma site exporting to the United States, its compliance is non-negotiable. We implement it on automation and MES systems with four pillars: electronic signatures linked to identity (password + unique identifier, or biometrics), tamper-evident audit trail recording who did what and when on critical data, strict user account control (provisioning, deactivation, periodic review of rights), and protection against unauthorized modification or deletion of records. 21 CFR Part 11 validation must be architected from the FDS, never added at the end of a project, at the risk of heavy refactoring and FDA audit exposure.
batch control
ISA-88
ISA-88 (ANSI/ISA-88 and IEC 61512) is the international standard that structures batch control systems. It defines a physical model (enterprise, site, area, process cell, unit, equipment module, control module) and a procedural model (procedure, unit procedure, operation, phase) that decouple the recipe from the PLC code. We systematically use it on multi-recipe or multi-product projects: sequencing logic (recipe) is managed separately from machine execution (phases), which radically simplifies maintenance and accelerates the OQ and PQ phases. Without ISA-88, every new recipe requires custom code and triggers requalification. With well-implemented ISA-88, adding a recipe becomes a documented configuration operation, without modification of validated PLC code.
MES integration
ISA-95
ISA-95 (ANSI/ISA-95 and IEC 62264) is the international standard that structures vertical integration between production systems (level 0 to 2: sensors, controllers, SCADA), MES (level 3: execution, traceability, batch genealogy, resource management, quality management) and ERP (level 4: planning, finance, supply chain). We use it as a reference framework to specify data exchanges between layers: downstream production orders, upstream production reports, material management, batch release. The standard also defines an exchange format (B2MML, XML based on ISA-95) that standardizes interfaces. On a pharma project, clean ISA-95 integration simplifies audits, accelerates MES commissioning, and limits costly custom developments to validate.
OT cybersecurity
IEC 62443
IEC 62443 is the suite of international standards dedicated to the cybersecurity of industrial systems (OT, Operational Technology). It defines four security levels (SL1 to SL4) and structures requirements for operators, integrators and component vendors. We systematically apply it to new pharma and industrial projects: network segmentation (zones and conduits), hardening of controllers and HMIs, remote access management, logging, patch management, incident response plan. In 2026, ignoring IEC 62443 on a new pharma project has become indefensible: Swissmedic, FDA and cyber insurers rely on this reference to assess OT maturity. Missing or poorly designed segmentation at commissioning is almost impossible to correct after go-live without a production shutdown.
OPC UA
OPC UA
OPC UA (Open Platform Communications Unified Architecture, IEC 62541) is the reference industrial protocol for data exchange between OT equipment and IT systems. Successor to OPC Classic, it is cross-platform, vendor-independent, natively secure (TLS encryption, certificate authentication), and carries a structured information model (companion specifications) that standardizes data semantics by sector. We use it on nearly all our modern automation projects to connect controllers, SCADA, MES and data platforms. Pharma companion specifications (for example OPC UA for Pharma 4.0) accelerate integration by standardizing data models for filling, lyophilization and weighing equipment. Combined with PubSub (since version 1.04), OPC UA also covers real-time needs and cloud architectures, making it the backbone of pharmaceutical industry 4.0.