Software Validation at the Vendor not Enough
483 Observation
The FDA inspection of a human tissue bank ended with
with two observations. One of the them was related to software validation.
It simply stated: The performance of computer software has not been
verified. Specifically, your firm has not verified the computer software
program being used of their donor referral operation to ensure that the
electronic records are trustworthy, accurate and reliable.
Establishment Inspection Report
More information on what was wrong was included in the
Establishment Inspection Report from the same inspection. It listed the same
observation but a section on supporting Evidence and Relevance: The firm
must verify the performance of the computer software for the intended use
and document these activities.
Further details were documented in the section:
Discussion with Management. The inspector wrote down questions and answers
provided by the company
According to the report, the firm used a computer
software program that is manufactured by (supplier) and has collected
donors. The report continues: During he inspection, I (the inspector) asked
the manager of clinical operations if the computer software has been
validated to assure that it performs for its intended use. The manager told
me that the software was validated by the manufacturer. The manager provided
me a copy of a letter they received from the manufacturer indicating that
the software was validated. The manager also gave me a copy of validation
information that was obtained from the manufacturer during the inspection
I told the manager that I still needed to see what
they have done to validate the system since the computer was making a
decision to accept or reject potential donors. The manager of clinical
operations and the manager of the communications center told me that they
were unaware that the company had to validate the software because it was
validated by the manufacturer and that was the reason for purchasing this
software.
The Company's Response
In the meantime, the company has sent a letter to the
FDA with a response to the observation:
"Immediately following the inspection, the company began the verification
process of the software. The verification process is complete with the
supporting documentation available for review."
How to get the 483, EIR and Company Response
The 483, the EIR and the company response can be
downloaded from the
Labcompliance Usersclub. Non members can
preview excerpts. Scroll down and to
W-226 for the 483 to W-191 for the EIR and the company response
Recommendation from Labcompliance
Labcompliance recommends to share validation tasks
between the manufacturer and user
The manufacturer should
- Provide a list of functional specifications
- Develop the software in a quality assurance
environment
- Develop the software according to documented
procedures
- Test each function of the software
- Allow the user to review the development
processes, test procedures and test protocols
- Provide the user with a document stating that the
software has been developed and tested according to the company
procedure (optional)
- Provide services for installation, installation
qualification and operator training
- Provide services for verification of key
functions in the user's environment (optional)
The user should
- Develop user requirement specifications, that for
commercial off-the-shelf (COTS) systems typically is a subset of the
complete set of functional specifications
- Conduct a manufacturer assessment to check
conformance with requirements as specified above
- Installs the software and documents installation
- Verifies performance for intended use. This
includes testing of functions that are critical and/or can be impacted
by the environment. It also includes all configuration settings made for
the software specifically for the use. It also includes user specific
test data.
- Develop a maintenance and ongoing test program to
ensure ongoing performance
- Develop and implement a change control and
revalidation procedure to ensure that the software maintains it's
validation state after changes
- Write a validation report and archive the report
and all supporting documents.
More information
- Get step-by-step advice on software and computer
system validation and receive 10+ Best Practices documents for easy
implementation in the Labcompliance audio Seminar
Computer System validation: Step-by-Step.
Other Examples of FDA Warning Letters / 483's Related
to Computer System Validation
- FDA Inspectors also found many other deviations
related to computer validation. To see examples,
click here.
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