'The one-size-fits-all approach to these SOPs isn't useful. Template SOPs are available elsewhere, but these never fit what a specific company needs.' - Brian Shoemaker, Principal Consultant at ShoeBar Associates
Dedham, MA (PRWEB) December 10, 2013
ShoeBar Associates announces the availability of a no-cost resource "Thoughts for Developing Software Quality Procedures," intended to aid FDA-regulated companies which need to set up a formal software quality infrastructure.
Though the same quality requirements apply everywhere, every organization manages its software development differently. This guide, distilled from years of SOP development and refinement for medical device and related companies, provides a standard SOP structure, but within that asks the questions needed to tailor SOPs to a company's unique organization and needs. According to Brian Shoemaker, Principal Consultant at ShoeBar Associates, "The one-size-fits-all approach to these SOPs isn't useful. Template SOPs are available elsewhere, but these never fit what a specific company needs."
In contrast, "Thoughts for Developing Sofware Quality Procedures" outlines the topics and asks the questions necessary for a company to develop its own SOPs for regulated medical product software development. All standard procedure topics are addressed, from software quality planning and software development processes down to issue tracking, configuration management, and software release. Thoughts for each document are organized according to a typical SOP outline, but this outline is not mandatory.
To download this valuable free white paper, please visit our website at http://www.shoebarassoc.com.
About ShoeBar Associates
Headquartered in Dedham, Massachusetts, USA, ShoeBar Associates is a consultancy focused on software quality and software validation related services for regulated healthcare products companies.