README

R-IQ-OQ is an R/Sweave based program designed to serve as a foundation for the 
Installation Qualification (IQ) and Operational Qualification (OQ) of R 
(http://www.r-project.org/) when used in environments (such as regulated 
clinical trials) where such processes may be required.

In these environments, documentation is typically required to demonstrate that 
software applications have been installed correctly using vendor defined 
procedures and that the application is operating correctly, using a pre-defined 
set of tests.

The R-IQ-OQ.Rnw file will generate an automated report that provides output 
that can be part of **user defined and created** standard operating procedures 
(SOPs) in which such IQ and OQ tests are performed. These post-installation tests
are defined by the R Foundation in the "R Installation and Administration Manual" 
available at:

  http://cran.r-project.org/doc/manuals/R-admin.html

For regulated clinical trials, the R Foundation also provides a document
entitled:

  R: Regulatory Compliance and Validation Issues A Guidance Document 
      for the Use of R in Regulated Clinical Trial Environments

available from:

  http://www.r-project.org/doc/R-FDA.pdf

which provides guidance on the use of R in such environments, including 
references to relevant FDA regulatory guidance documents, descriptions of R's 
Software Development Life Cycle (SDLC) and information regarding the 
applicability of various aspects of Title 21 of the U.S. Code of Federal
Regulations Part 11 (21 CFR 11) and how R fits within that framework.

Note that there is also a more general description of R's Software Development
Life Cycle (SDLC), which is available from:

  http://www.r-project.org/doc/R-SDLC.pdf

and contains a subset of the relevant content from the R-FDA document, excluding
the content that is specifically targeted to clinical trials.

It is important to note that the output of the R-IQ-OQ program is designed 
to serve as a general purpose template for use by those operating in 
environments where installation and operational qualification of
software applications is deemed to be needed. The structure and content of
the resultant report may not satisfy all needs and you are free to modify
the report as your local requirements and SOPs may necessitate. 

There are important notes in the beginning of the R-IQ-OQ.Rnw file that
should be completely reviewed regarding how to run the program and related
considerations for environmental settings (eg. locale) that can affect the
output generated.

You will need a local installation of LaTeX in order to process the resultant
R-IQ-OQ.tex output file into the final R-IQ-OQ.pdf file. Most Linuxen will 
either include a LaTeX installation or will provide binaries for easy 
installation from repos. Windows users will want to look at MikTeX and OSX 
users at MacTeX, which are provided by third parties.

There are a series of CMDFile*.r files which contain R code that are required
and are called in a BATCH mode operation from within R-IQ-OQ.Rnw. Be sure
that these files are present in the same folder as R-IQ-OQ.Rnw.

All programs are made available under the GNU GPL version 2 license, so please 
observe the copyright and distribution requirements of that license. See
the COPYING file included.