Documentation Listing for Products
Documentation at Chase-Logeman follows the Life-Cycle design model, and is admissible to the FDA as validation documentation. All documentation can be re-formatted into customer supplied document formats.
This high-level document describes the functionality of the system in broad terms, and relates to the requirements defined by the customer. This document is used to produce the Functional Requirements document.
This document describes a set of detailed requirements for each functional aspect described in the Functional Description document. This document is used to produce the Functional Specification document.
This document describes details for each requirement listed in the Functional Requirements document and is used to produce the mechanical features and software source code. Included in this document are detailed descriptions of inputs, outputs, configuration, sequencing, and functionality. This document references mechanical drawings and wiring diagrams.
Design Qualification (DQ):
This document is used to ensure validity of the equipment design. Design principles, software flow and guidelines, material force analysis, heat dissipation guidelines, vibrational tolerances, and pressurization principles are all examples of components examined under this protocol. Installation
Installation Protocol (IQ):
This document is used to ensure validity of the component installation. Wiring continuity, calibration, limit switch span, materials of construction, piping drain-ability, welding, and air line pressurization are all examples of components tested under this protocol. The IQ can be used as part of a factory acceptance test, or used upon site installation.
Operational Qualification Protocol (OQ):
This document is used to ensure validity of the componentsï¿½ individual operation. Timing, mechanical flow, software functionality, valve actuation, security, and data integrity are all examples of components tested under this protocol. The OQ can be used as part of a factory acceptance test, or used upon site installation.
Performance Qualification Protocol (PQ):
This document is used to ensure validity of the integration of all systems within the equipment. Typically this test would involve manufacturing and packaging actual or substitute product through the machine to specific design criteria, such as units per minute, fill level deviation, or cap torque. The PQ should be executed once the equipment is installed at the customer location.
Relational Cross Matrix:
This document relates broad specifications and requirements of the Functional Description and Functional Requirements to- detailed specifications within the Functional Specification. Additionally, it relates the functional specifications to actual software modules and mechanical components. It relates the software
modules and mechanical components to the DQ, IQ, OQ, and PQ, so as to provide linear traceability throughout the design, construction, and testing of the system. The cross matrix can also show how these components relate to the
installation, operation, and maintenance procedures for the equipment.