APR Sept/Oct 2023 - 83

WHITEPAPER
Data quality
Ensure the collection and storage of electronic records is aligned with
FDA guidance, which states that data integrity depends on reliable,
accurate, usable, complete, and unaltered data.2
cGMP Compliance Through CSV
A microbial ID system
that has been designed with data integrity and compliance in mind is
critical for cGMP.
Computer Systems Validation (CSV)
While features of a microbial ID system are important in enabling
regulatory compliance, it is essential to base the ultimate procurement
decision on an explicit understanding of regulatory requirements to
validate the system workflow and have a defined plan to get there
from the start. Validation of laboratory systems is defined in various
parts of the US FDA Code of Federal Regulations, such as Title 21 (21
CFR): part 211 (Good Manufacturing Practice) and Part 11 (Electronic
Records and Electronic Signatures),3
for example. This goes beyond
instrument qualification. CSV is a critical and comprehensive path to
documenting data integrity to achieve regulatory compliance of a
microbial ID system.
Implementation Options
Installation of equipment is usually straightforward and performed by
a field service engineer with additional documentation for instrument
qualifications (IQ/OQ). Training of operators on use of the instrument,
software, and workflow is often performed by a field application
scientist.
Any complete implementation program should include:
* Assistance in setting up the laboratory in accordance with good
molecular laboratory practices
* Checklist of installation material requirements and procedures
*
Introduction to the basics of the workflow and traditional
culture methods
*
Introduction to the background of the method
* Throughput organization from a few to hundreds of samples per
day
* Practical sessions in the workflow
* Software training
* Analysis flow from data collection to identification
* Acceptance criteria for quality analysis
* ID results interpretation
* Qualification services
* Routine system maintenance
* Data archiving
* Recommendations for performance qualification protocols
* CSV
Execution of a CSV is beyond the normal installation and training of a
microbial ID system provided by field engineers and scientists, yet is
fundamental for regulatory compliance in a GMP environment.
To satisfy this requirement, companies have 3 options, each with their
own considerations:
1. Hire a third-party consultant for implementation
and CSV.
* Do they have experience with regulatory requirements
and quality?
* Do they have the technical knowledge of the microbial
ID system?
* Will bringing in an additional party increase the complexity of
the project?
2. Use internal company resources (e.g., quality and
IT departments).
* Do they have experience with the hardware and software
features of a microbial ID system?
* Do they have the necessary experience with
regulatory requirements?
* Do they have the bandwidth?
3. Choose a microbial ID system manufacturer that
can provide:
* Detailed knowledge of regulatory requirements.
* Technical expertise specific to their instrument and software.
*
Large and experienced CSV support team.
* Rapid implementation of a validated system.
Not all instrument manufacturers have experience in executing a
computer systems validation. Before choosing this option, verify the
microbial identification system manufacture has a long history of
successful CSV consulting services that consist of:
* Dedicated project management and documentation approvals
- A project manager, who guides the customer through the
validation process.
* Validation test execution and customer approvals - A validation
specialist, who understands industry-specific processes and
executes test plans.
* SAE software workflow analysis - This specialist possesses
knowledge of features and functions of software to
be validated.
* Pre-form template documentation - A standard set of
documents with flexibility to accommodate customer needs.
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