'the quality of being systematic'


Effective - Efficient - Agile - Compliant

Business Process Excellence







Compliance & Validation

Organisations operating in regulated environments are subject to a high degree of scrutiny, for example:

  • Pharmaceuticals - FDA 21 CFR rules, EU Directives and national regulations
  • Financial - Sarbanes-Oxley Act (SOX)

They are expected to validate their processes and systems to provide documented evidence that predetermined specifications are consistently met.


Increasingly organisations in many sectors are expected to demonstrate to all their stakeholders that they are operating in legal, ethical, secure, responsible and also cost effective ways. This means a greater need for management to implement transparent and effective controls over all aspects of their organisation.


Many organisation have implemented, are implementing or are considering implementing Quality Management Systems (QMS), such as ISO 9001, to meet these operational constraints. It is critical to achieve effective control without creating a bureaucratic millstone. Quality is key to organisational agility.


Another component in the resolution of these apparently conflicting demands is the adoption of control frameworks such as COBIT and ITIL. Properly implemented these can contribute to the agile organisation.

We have an integrated approach to quality, frameworks and processes to achieve cost-effective compliance, validation and governance.

Our experience includes defining strategies, 'hands on' activities, implementing quality systems and frameworks and performing prospective and retrospective validation.



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