APR Sept/Oct 2023 - 84

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A comprehensive CSV consulting service develops and produces
documentation to verify that all software features are within scope
for data security, auditing, and e-signature and are suitable for
their intended use. Industry-standard validation practice uses 12
components to document that a system has achieved or maintained
compliance requirements (Table 1).
Table 1
Validation plan
Validation risk assessment
User requirements
specification
System configuration
specification
Validation test plan
Installation qualification with
objective evidence
Operational qualification
with objective evidence
Performance qualification
with objective evidence
Traceability matrix
21 CFR Part 11/Annex 11/
GAMP™ 5 Assessment
Quality assurance review
Validation summary report
Real-world experiences implementing
and validating microbial identification
systems in a cGMP environment
Here are three real-world experiences of customers who implemented
a microbial ID system and undertook CSV in their facilities. In all three
cases the companies chose to purchase the Applied Biosystems™
MicroSEQ Microbial Identification System™ but undertook the CSV by
various means.*
Case study 1 - Use of a third-party contractor for CSV
A company hired an external contractor to create the validation
package and documentation for its CSV. For successful validation, the
contractor needed to special control and access all the software on the
company's system.
Unfortunately, the contractor had no system training and wasn't
experienced with MicroSEQ ID instruments or the software. As part
of the validation process, the contractor created some worst-case
scenarios in the software that resulted in software conflicts and errors,
that the contractor didn't know how to resolve. The company had to
seek software error resolution from a Thermo Fisher Scientific field
service engineer and field application scientist.
Validation, which normally takes weeks to complete, took more than
18 months and included numerous software conflicts that had long
resolution times. Users could not use the system until it was validated.
The long resolution times meant the company needed to be trained
again on the operation of the system once the long validation process
had been completed.
The result was considerable additional expense due to the need for
outsourced testing during the unexpected timeline for validation from
the third party, and an excessively long time to validation.
*For research purposes only
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Case study 2 - Use of internal company resources
for CSV
Another company attempted complete its CSV on its own. Its internal
department was responsible for data integration (DI) and data storage
(DS) for all computer-based systems based on knowledge of specific
technologies and processes, so they thought they had the expertise.
Unfortunately, an FDA audit found DI/DS security risks unique to the
way the company set up its MicroSEQ ID System. These included the
ability to delete or alter data, which is a considerable problem for a
cGMP facility. In addition, data backups were neither compliant nor
secure, and there were problems with individual user logins.
The company sought to correct these errors by engaging validation
support from Thermo Fisher Scientific. While this temporarily
increased turnaround time for their microbial identification-samples
had to be sent to an external lab for identification until validation
was complete-it minimized the overall downtime, minimized the
temporary costs of sending out samples, and restored compliance of
data integrity requirements.
After validation support, a subsequent FDA audit found that all issues
had been resolved.
Case study 3 - Implementation of a regulatory
compliant system in only six weeks by
Thermo Fisher Scientific
A company needed to implement an additional microbial ID system
identical to the one it currently had on site for higher volume samples
and redundancy. As a high-throughput laboratory, performing thousands
of tests every year, the goal was for this new system to be fully
validated and ready to run within six weeks.
The company shared this need with Thermo Fisher Scientific. At the
same time as purchasing the instrumentation, they also contracted
Thermo Fisher Scientific's CSV consulting services, which integrated
seamlessly with all of its other specialists: technical sales specialists,
field service engineers, field application scientists, and CSV compliance
team members. All of the preloaded CSV documents from the current
system-i.e., all the documents listed in Table 1-were applied to the
new one.
A library validation plan was also created for the company. This
allowed it to have less downtime on its new system, a benefit for this
high-throughput lab.
A tight implementation schedule was possible due to the preloaded
documents, a prepared library validation plan, and coordination
between the field teams. This allowed the new system to be
operational and begin microbial identification within the specified six
weeks timeline.
The result was no downtime at the customer site. The company was
able to use its existing system and keep it running while the new one
was put in place. Then, when the new system was in place, updates
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