Biomedical Engineering Reference
In-Depth Information
TABLE 13.1 Responsibilities of the System Experts Involved in an Instrument
Validation
Responsible Team Member
System
expert
Quality
assurance
Project
manager
Scientific
management Consultants
Components/Deliverables
Validation plan
x
x
Requirements/design
specification
x
x
x
x
x
Test protocols
x
x
x
Traceability matrix
x
x
x
Validation summary report
x
Document review
x
Time line creation and
monitoring
x
The components and deliverables listed in column 1 of the table are called out in Figure 13.2. Delineation of
roles and responsibilities ensures an efficient validation process without duplication of effort.
records in that instrument/server, and this can provide an opportunity to those not
authorized to access specific data sets tomodify files or temper with them. In this case,
the instrument would be considered to have breached the requirement of a closed
system.
The practical solution to a technical breach of validation requirements need not be
the exclusion of flow cytometry from GLP studies. Although some have chosen to
identify flow cytometry efforts as “non-GLP components of GLP studies” due to gaps
in technical controls, this may be inadvisable. Rather, a judicious use of procedural
controls demonstrating that the management (1) is aware of the gaps that exist, (2) the
management has developed predicated in-house processes and correlated the staff
training curricula, and (3) the management has allotted time to review and enforce
such controls as to meet the regulatory requirements is the advisable path forward.
Examples of procedural controls include limited access to the system to authorized
personnel and revocation of privileges set forth by standard operating procedures
(SOPs). Another example is to require (by SOP) that users change their passwords at
least once every 90 days. The third example is to require that raw data files shall not be
altered, deleted, or overwritten. It is, therefore, a combination of technical and
procedural controls that ensure appropriate system control and adherence to GLP
requirements.
13.2.2.1 Instrument Validation 101: The Process Once the compliance risk
has been assessed and a validation team has been assembled, meaningful
consultations (i.e., the system compliance assessment) about the validation plan
can begin. In this setting, definition of validation requirements, review (or authorship)
of instrument-specific SOPs, and any procedural controls that are envisioned are
detailed. Instrument validations can be focused by restricting validation to a particular
instrument functionality that will be usedwithin the regulated space. For instance, one
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