INSTRUMENT VALIDATION FOR REGULATED STUDIES - Flow Cytometry in Drug Discovery and Development - page 268

any required configuration details, needs to be combined with a documented
evaluation of any future change to hardware and software from the very start.
Thus, as part of the validation process it is important to identify what future
changes may be made to the system that modify the validated state and therefore
require additional testing and/or calibration. In this regard, software upgrades and
major hardware replacement such as lasers, filter sets, or photomultiplier tubes should
be obvious. On the other hand, sheath/waste tanks and other consumables are not
likely to void the validated state, and time should be taken to identify these as
nonconsequential changes to the system. This ensures an appropriate level of control
without spending resources to overdocument changes.
Another essential procedure generated prior to or during the validation defines the
operation and maintenance of the system, including scheduled and unscheduled
maintenance. To ensure appropriate documentation, procedure-driven forms may be
utilized to capture the details of scheduled and unscheduled maintenance including
methods to assess performance after such interventions. To complete the exercise,
completed forms can be maintained simply in a logbook associated with the
instrument and reviewed and archived periodically.
Ultimately then, it is the documented evidence of changes to and maintenance of
the system that not only serves as a heath assessment of the instrument but also
represents the assurance that a system validation performed today is applicable to the
data that are generated from that instrument tomorrow.

13.5 IN CLOSING: VALIDATION MEANS VALIDATION

A comprehensive understanding of instrument validation is very important to those
conducting flow cytometry investigations for biopharmaceutical companies.
Although the complexities of validation efforts may be initially daunting, the value
of taking time to understand the regulatory landscape with respect to a given project
cannot be underemphasized. It is easy to incorrectly assign regulatory oversight to an
analysis work stream, but ample resources are available to thosewho need to calibrate
their activities in the regulated space. Perhaps, the best advice to those entering
the regulated environment is to live by the maxim that validation means validation:
those who study the requirements, parse out the responsibilities, partner with those
best qualified to meet the set of validation requirements, and make adjustments to
maintain the validated state will succeed and add value to thework group that depends
on this expert function.

REFERENCES

1. Guidance for Industry. Part 11, Electronic Records: Electronic Signatures - Scope and
Application. U.S. Department of Health and Human Services, Food and Drug Adminis-
tration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation
and Research (CBER), Center for Devices and Radiological Health (CDRH), Center for