Agent Ontology
This module contains terms and relations necessary for representing various types of agents (actors) in biopharmaceutical manufacturing. The actors here correspond to both human actors as well as engineered systems and organizations.
Cameron Gibbs, CrownPoint Technologies, LLC
Melissa Weller, CrownPoint Technologies, LLC
Stephen J. Granite, CrownPoint Technologies, LLC
Stephen Kahmann, CrownPoint Technologies, LLC
Copyright (c) 2022, 2023, 2024, 2025, 2026 Open Applications Group
agent identification
Contractor ID code used to reference a quality audit team in batch release documentation; Employee ID badge number assigned to a technician responsible for operating a bioreactor
AgentIdentification(x) ↔ Identifier(x) ∧ ∃y(Agent(y) ∧ designates(x, y))
identifier for a person, group of persons, or engineered system with an agent role
every instance of 'agent identification' is defined as exactly an instance of 'identifier' that 'designates' some 'agent'
manufacturing operator
trained person that uses thawing equipment to initiate the thawing of a vial retrieved from liquid nitrogen storage; a skid-mounted dosing unit with integrated sensors and actuators that controls a solid feeder to dispense a specified amount of Benzoyl Peroxide into a polymerization reactor as part of a PVC resin production process; a person who is planned to operate a centrifuge during a cell harvest step in a biomanufacturing process
See the expanded definition under the corresponding role class. The term is formalized here as a defined class by referring to its corresponding role class and exists primarily for ontological modeling and implementation convenience.
ManufacturingOperator(x) ↔ (Person(x) ∨ EngineeredSystem(x)) ∧ ∃r(ManufacturingOperatorRole(r) ∧ hasRole(x, r))
person or engineered system with a manufacturing operator role
every instance of 'manufacturing operator' is defined as exactly an instance of 'person' or 'engineered system' that 'has role' some 'manufacturing operator role'
manufacturing operator role
role of a trained person that uses thawing equipment to initiate the thawing of a vial retrieved from liquid nitrogen storage; role held by a skid-mounted dosing unit with integrated sensors and actuators when it controls a solid feeder to dispense a specified amount of Benzoyl Peroxide into a polymerization reactor as part of a PVC resin production process; role held by a person who is planned to operate a centrifuge during a cell harvest step
ManufacturingOperatorRole(x) → AgentRole(x) ∧ ∃y((EngineeredSystem(y) ∨ Person(y)) ∧ roleOf(x, y) ∧ ∀z(hasRealization(x, z) → (ManufacturingProcess(z) ∧ ∃c∃e(Capability(c) ∧ PieceOfEquipment(e) ∧ capabilityOf(c, e) ∧ realizes(z, c)) ∧ hasParticipantAtSomeTime(z, y))))
agent role held by a person or engineered system when it uses, controls, or is planned to use or control one or more pieces of equipment to carry out some manufacturing process
There are insufficient constructs to define necessary and sufficient conditions. Namely, patterns for useing or controlling the equipment need to be developed further.
If x is a 'manufacturing operator role', then x is an 'agent role' that is the 'role of' some 'engineered system' or 'person' y, and whenever x is 'realized by' some z, then z must be a 'manufacturing process' that 'realizes' a 'capability' which is a 'capability of' some 'piece of equipment', and z must 'have as participant at some time' y
validator
Head of the Process and Product Control Laboratory who signs the gas chromatography analysis of a PVC lot, confirming its conformance to specification criteria; Quality Assurance Department that issues in-process control reports for production batches based on automated test results and predefined acceptance criteria, without requiring individual sign-off
Validator(x) ↔ (Person(x) ∨ Organization(x) ∨ EngineeredSystem(x)) ∧ ∃r(ValidatorRole(r) ∧ hasRole(x, r))
person, organization, or engineered system with an validator role
Every instance of 'validator' is defined as exactly an instance of 'person', 'organization', or 'engineered system' that 'has role' some 'validator role'
validator role
role held by the Head of the Process and Product Control Laboratory when they sign the gas chromatography analysis of a PVC lot, confirming its conformance to specification criteria; role held by a Quality Assurance Department when it issues in-process control reports for production batches based on automated test results and predefined acceptance criteria, without requiring individual sign-off
ValidatorRole(x) → AgentRole(x) ∧ ∃y((EngineeredSystem(y) ∨ Organization(y) ∨ Person(y)) ∧ roleOf(x, y))
agent role held by a person, organization, or engineered system when it assesses the conformance or acceptability of an information artifact, material entity, or planned process against specified criteria
There are insufficient constructs to create necessary and sufficient conditions. Namely, a full set of constructs for representing assesing the conformance or accebtability of all the entities in the definition are lacking.
If x is a 'validator role', then x is an 'agent role' that is the 'role of' an 'engineered system', 'organization', or 'person'.