Regulatory Compliance

Many businesses operate in sectors where regulatory compliance is a challenging fundamental business imperative.  Failure to comply with the ever more demanding and diverse regulations can result in severe financial penalties and, more importantly, have a devastating impact on the organisation’s reputation and share price.

The underlying principle of most regulations is to ensure that the business is transparent, and has the appropriate processes and controls.  Modern software-based information systems are at the heart of all business processes and controls.  We recognize that one cannot address regulatory compliance without ensuring that the operational IT systems and controls are robust and reliable and provide predictable operational results and appropriate and timely management control information.  The outputs from the systems must support, demonstrate and provide evidence of regulatory compliance.

Software quality assurance and systems verification and validation are essential foundations on which every regulatory compliance regime is built.

We provide software systems quality assurance and systems verification and validation services for those industry sectors that are subject to strict regulatory controls, in particular Financial Services and Life Sciences.

Our consultants have expertise in interpreting and implementing the requirements of the diverse regulations such as FDA CFR Part 11, Sarbanes-Oxley, and Basel II and the evolving MiFID requirements as they relate to IT practices and controls and, in particular, IT quality assurance and testing.

Our services are focused on implementing best practice quality assurance and test processes throughout the Software Development Life Cycle (SDLC) to underpin regulatory compliance. Our service offering includes strategy development, best practice implementation, support for process improvement initiatives, and the implementation of controls and tools that will help ensure you are compliant and stay compliant.  Our best practice risk-based test methodology, TestControl™, is particularly suited to this environment.

Our SDLC perspective ensures that at the requirements and design phase, there is early life cycle test and validation to ensure that new systems will conform before they are built. Our practitioners develop and implement full life cycle test strategies that support best practice in a form that is consistent with the risk management theme of the regulations. We incorporate the more detailed confirmation and record keeping throughout the software development cycle (SDLC) that is an evidential requirement in the regulatory environment.

We work with IT industry Frameworks and Standards such as CobiT, ITIL, CMMI, as appropriate, to the environment to facilitate the implementation of best practice to meet both business and regulatory compliance goals.

In developing and implementing complete lifecycle strategies appropriate to a specific regulatory regime, we add substantial value and make a significant contribution to ensuring that software systems used throughout the organisation conform to best business practice and meet all regulatory requirements.

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