The Medical Device Validation Handbook
173
Equipment Validation—Its Purpose
When searching for the word “validation,” many
definitions are found. Essentially, however,
validation breaks down into addressing basic
expectations, stated or unstated (all requirements
and expectations in regulated industry must be in
writing), that led to the initial acquisition of the
equipment.
Thus, validation involves proving all expec-
tations and requirements have been met by
observation, checking, testing, and performing
similar quantifiable activities, and are sustain-
able and reproducible over time, given expected
(allowed) variation in all foreseeable inputs.
Understanding equipment validation
requires the definition of validation inputs, i.e.,
requirements and specifications (Figure 12-1).
A “requirement” can be any system or
discrete equipment need or expectation.
Requirements reflect the customer’s stated
or implied needs, and may be market-based,
contractual, or statutory, or included in an
organization’s internal requirements. Applicable
standards provide requirements. Many different
requirement types may exist (e.g., design, func-
tional, implementation, interface, performance, or
physical requirements). Equipment requirements’
specifications typically are derived from the
requirements needed for it to function as part of
a production or test environment.
Documenting such requirements accurately
and completely is crucial in successful equipment
validation because the requirements’ specifica-
tions form the basis for all verification steps (test
cases or scripts).
A “specification” is defined by the US Food
and Drug Administration as a “document that
states requirements.”1 It may refer to or include
drawings, patterns, or other relevant documents
and usually indicates the conformity means and
criteria with the requirement can be checked.
Many kinds of written specifications (e.g., use,
function, or system requirements’ specifications
equipment design specifications test specifica-
tions and integration specifications, etc.) establish
“specified requirements,” and are design inputs for
which various forms of verification are necessary.
Such “expectations, requirements, and speci-
fications” also could include any of the following:
• Resulting equipment meets predetermine
expectations (requirements)
• Challenge the equipment to its “allowable
worst case” inputs
• Verify all requirements have been met
per a “requirements specification” (one or
Equipment Validation
John E. Lincoln
12
173
Equipment Validation—Its Purpose
When searching for the word “validation,” many
definitions are found. Essentially, however,
validation breaks down into addressing basic
expectations, stated or unstated (all requirements
and expectations in regulated industry must be in
writing), that led to the initial acquisition of the
equipment.
Thus, validation involves proving all expec-
tations and requirements have been met by
observation, checking, testing, and performing
similar quantifiable activities, and are sustain-
able and reproducible over time, given expected
(allowed) variation in all foreseeable inputs.
Understanding equipment validation
requires the definition of validation inputs, i.e.,
requirements and specifications (Figure 12-1).
A “requirement” can be any system or
discrete equipment need or expectation.
Requirements reflect the customer’s stated
or implied needs, and may be market-based,
contractual, or statutory, or included in an
organization’s internal requirements. Applicable
standards provide requirements. Many different
requirement types may exist (e.g., design, func-
tional, implementation, interface, performance, or
physical requirements). Equipment requirements’
specifications typically are derived from the
requirements needed for it to function as part of
a production or test environment.
Documenting such requirements accurately
and completely is crucial in successful equipment
validation because the requirements’ specifica-
tions form the basis for all verification steps (test
cases or scripts).
A “specification” is defined by the US Food
and Drug Administration as a “document that
states requirements.”1 It may refer to or include
drawings, patterns, or other relevant documents
and usually indicates the conformity means and
criteria with the requirement can be checked.
Many kinds of written specifications (e.g., use,
function, or system requirements’ specifications
equipment design specifications test specifica-
tions and integration specifications, etc.) establish
“specified requirements,” and are design inputs for
which various forms of verification are necessary.
Such “expectations, requirements, and speci-
fications” also could include any of the following:
• Resulting equipment meets predetermine
expectations (requirements)
• Challenge the equipment to its “allowable
worst case” inputs
• Verify all requirements have been met
per a “requirements specification” (one or
Equipment Validation
John E. Lincoln
12