8.3.4 VALIDATION PHASES
Conceptually, a life - cycle approach to laboratory instrument validation can be
divided into four phases, as shown in Figure 1 .
8.3.4.1 Planning and Requirements Phase
The activities in the planning phase are commenced after a business need to implement
an instrument in the laboratory has been identifi ed. Planning - phase activities
include concisely documenting the user requirements and functional requirements
of the instrument. Once established, the requirements are then used to evaluate the
instrument candidates available from suppliers. A validation plan with deliverables
that are commensurate with the class of the instrument being implemented should
be developed during the planning phase.
Validation Plan A validation plan is prepared to highlight the activities and
deliverables required in the implementation of the laboratory instrument. The
details of the validation plan should be scaled according to the complexity of the
system, its intended use, and the impact on the business. A generic validation plan
can be used for similar types of laboratory instruments with similar applications.
For example, one validation plan can be prepared for the HPLC. A validation plan
typically includes the following sections:
• Objectives and Scope of Project Rationale for implementing the instrument
with its key applications and to state the assumptions, exclusions, and limitations
of the project.
• System Description Hardware, software, and system confi guration (if the
system is comprised of different modules or components).
• Compliance Assessment State whether the use of the analytical instrument is
subject to GxP and regulatory requirements. Instruments subjected to GxP
will need validation. A rationale should be provided to support the decision of
the assessment.
• Validation Approach and Deliverables Outline the required documents, qualifi
cation testing, and reports to be included in the validation project. The deliverables
should be based upon the complexity and the risk associated with the
intended use of the system. The deliverables will highlight the acceptance criteria
to demonstrate that the system has met the requirements for its intended
use.
• Roles and Responsibilities List the group(s) or personnel that are responsible
for the validation of the instrument.
• Project Timeline and Milestones List the projected completion date of major
tasks in the validation. This information is useful in monitoring the progress of
the project and making sure proper resources are available at various stages of
the validation.
• Record Management Describe the format, numbering sequence, revision,
version control, and storage of the validation documentation.
Conceptually, a life - cycle approach to laboratory instrument validation can be
divided into four phases, as shown in Figure 1 .
8.3.4.1 Planning and Requirements Phase
The activities in the planning phase are commenced after a business need to implement
an instrument in the laboratory has been identifi ed. Planning - phase activities
include concisely documenting the user requirements and functional requirements
of the instrument. Once established, the requirements are then used to evaluate the
instrument candidates available from suppliers. A validation plan with deliverables
that are commensurate with the class of the instrument being implemented should
be developed during the planning phase.
Validation Plan A validation plan is prepared to highlight the activities and
deliverables required in the implementation of the laboratory instrument. The
details of the validation plan should be scaled according to the complexity of the
system, its intended use, and the impact on the business. A generic validation plan
can be used for similar types of laboratory instruments with similar applications.
For example, one validation plan can be prepared for the HPLC. A validation plan
typically includes the following sections:
• Objectives and Scope of Project Rationale for implementing the instrument
with its key applications and to state the assumptions, exclusions, and limitations
of the project.
• System Description Hardware, software, and system confi guration (if the
system is comprised of different modules or components).
• Compliance Assessment State whether the use of the analytical instrument is
subject to GxP and regulatory requirements. Instruments subjected to GxP
will need validation. A rationale should be provided to support the decision of
the assessment.
• Validation Approach and Deliverables Outline the required documents, qualifi
cation testing, and reports to be included in the validation project. The deliverables
should be based upon the complexity and the risk associated with the
intended use of the system. The deliverables will highlight the acceptance criteria
to demonstrate that the system has met the requirements for its intended
use.
• Roles and Responsibilities List the group(s) or personnel that are responsible
for the validation of the instrument.
• Project Timeline and Milestones List the projected completion date of major
tasks in the validation. This information is useful in monitoring the progress of
the project and making sure proper resources are available at various stages of
the validation.
• Record Management Describe the format, numbering sequence, revision,
version control, and storage of the validation documentation.
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