Introduction

The Safe-Side is an attempt to create a free development manual or QMS based on agile techniques for use in an regulated business area.
The agile techniques are characterised by a very dynamic approach solving the task at hand in a series fast iterations building the solution one piece at a time.
Regulated business areas are often considered tampered by a lot of rigid rules that has to be followed in order to be in compliance – but remember there is a reason for all rules and all rules should be applied based on the risk related to the groups the rules are supposed to protect.
But first two interesting thoughts about rules and following them.
Jim Wetherbee, Director NASAs Flight Crew Operation, has spent 1.591 hours in space in various roles and has these thoughts about the two ways to get into trouble:

  • Not following the rules!
  • Following the rules thoughtless!
Pablo Picasso, Spanish painter, has these thoughts about learning rules and applying rules.

  • Learn the Rules Like a Pro so You can Break them as an Artist!
Regulators usually do not prescribe a specific process or method for product development. Instead they make references to generally accepted standards as e.g. ISO, NIST, IEEE, ANSI, CENELEC, etc.
The rationale is that most standards are based on consensus among a lot of practitioners about what is Good Engineering Practice in an industry.
In this way the regulators obtains the benefit that they do not have to keep up with what is considered current good practice – this is done by the standardisation organisations.