Quality Assurance
at Rhoads Associates
Rhoads Associates is strongly committed to providing a quality product at
a reasonable price. Our quality approach has two central themes:
experience, and testing.
Experience
We do not have a "data processing department".
Instead, we have two very senior technical associates, with a combined
experience of 70+ years in clinical chemistry, computers, and statistics.
Dr. Rhoads, responsible for intellectual content, is an internationally
known Method Validation expert, and a board-certified clinical chemist, with
9 years experience as a hospital-based clinical chemist. He is directly
involved in the development process. Ms. Fleming, responsible for
implementation and testing, has an MS in applied mathematics, professional
experience in multiple computer languages and platforms, and experience in
writing software specifications, managing contractor implementation teams,
and performing software acceptance testing.
Testing
A typical development process has three phases:
Design, Implementation, and Testing. 30- 50% of our effort goes to the
Testing phase. Due to the experience of the two staff members, and the
direct communications channel between them, we place less emphasis on
written specifications and procedures during the design and implementation
phases than would be necessary in a larger company.
At the same time, we place greater emphasis on the
testing phase. We have been preparing formal, written, validation documents
for EP Evaluator since the release of EE4 in 2001. For each statistical
module, we 1) state the requirements, 2) identify a set of test cases to
verify these requirements, and determine correct answers from an independent
source, and 3) provide written pass/fail analysis. Moreover, we automate the
tests, and run them repeatedly both before and after release to confirm that
post-release changes have had no undesired side-effects. Our testing
procedure is sufficiently rigorous as to uncover several typographical
errors in the CLSI documents on which many of our statistical modules are
based.
Additional Information
General Validation Letter, documenting our validation process.
Introductory Chapters for the EE7 validation
documents
Sample Validation Chapter for one statistical
module.
