VALIDATION & QUALITY ASSURANCE
Nothing seems to cause more confusion, dissension, and anger
than these subjects.
Validation is not a substitute for good design, but it is an
important part of development and absolutely required for systems
subject to government regulation.
In the early stages it is important to show that something can
work - if funding is at stake, systems are often shown in the
most favorable circumstances.
As production nears, a skeptical attitude is needed - assume
a system doesn't work until it is 'proven' (documented evidence
demonstrates a high degree of confidence that the system will
perform as intended).
Realtors say the three most important things about a house are
location, location, and location. The military says they are logistics,
logistics, and logistics. Investors say they are management team,
management team, and management team. For Validation the three
most important things are planning, planning, and planning.
There are many kinds (and names) of plans, tests, and scripts.
There is no 'one approach fits all' road to success. Plans must
be tailored to the project: custom or off-the-shelf, hardware
versus software mix, in-house or purchased, single versus multiple
sites, degree of risk, etcetera.
A partial list of possible tests follows. Not every test applies
in every case.
Unit Test (UT) - Typically for software; also for hardware
components. Tests a single module over a range of conditions,
often greater than those expected in practice.
Integration Test (IT) - Typically for software. Tests
whether the program works as a whole. Much like an OQ (see below).
Alpha (Systems) Test - A development test of a complete
system in the hands of 'users', frequently used to test the logic
and/or completeness of requirements.
Beta (Field) Test - An uncontrolled test in the hands
of real users. This is also a type of development test.
Installation Qualification (IQ) Test - Ensures the 'parts'
are installed correctly. Critical for hardware, people have died
from incorrect wiring or plumbing. Commonly applied to network
cabling. Increasingly important for software due to interaction
between custom, commercial, and system software,
Operational Qualification (OQ) Test - This ensures that
the 'parts' work together and the system will operate over the
full range of conditions. This is often the basic test of whether
software runs.
Performance Qualification (PQ) Test - This ensures the
system meets requirements under actual operating conditions. Often
this is the same as an 'end-to-end' test.
Testing scripts must be pre-defined for the formal tests: the
UT, IT, IQ, OQ, and PQ.
It is important to tailor the tests to the system or project,
otherwise you risk expending enormous effort on useless tests
that miss a critical weakness. Auditors have a knack for finding
these. Nature will find that weakness and cause a failure. If
there is litigation, a lawyer will discover it also.
Ideally a system is designed from the beginning to avoid potential
problems. GSC can help you achieve this goal.
Validation (e.g., GLP, GMP, 21CFR11) must still be considered.
GSC can help you with this.
GSC develops complete system plans, not just software
plans.
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