Compliance & Validation
Organisations operating in regulated
environments are subject to a high degree of scrutiny, for example:
FDA 21 CFR rules, EU Directives and national regulations
Sarbanes-Oxley Act (SOX)
They are expected to
validate their processes and systems to provide documented evidence that
predetermined specifications are consistently met.
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.