DOCUMENTATION
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.

Functional Description:
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.

Functional Requirements:
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.

Functional Specification:
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
components� 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.

Documentation > Documentation Listing for Products

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