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FDA Compliance

Results, Reporting & Corporate Governance.



Regain order in your testing department, and stay on the right side of the law.



FDA, FSA, Sarbanes-Oxley, Basel-II – corporate compliance affects nearly all of us. Original Software can help ease this burden – while actually saving time and resources.


Corporate compliance measures affect most companies operating in the UK and Europe today. You are probably already facing some of these labyrinthine challenges.


You  need a way to make the whole process easier,  ideally saving money into the bargain! Well, it can be done.


Corporate compliance demands that companies  make fundamental changes to their core IT systems, that encompass corporate records and key management processes and reports. Such changes might take the form of developments to existing in-house applications, or perhaps outsourcing development, or maybe buying in and installing custom third-party solutions.


All of these involve introducing new software to established key systems – and they all bring  differing levels of change that must be managed in strict accordance with corporate compliance requirements. This is essential to guarantee the stability and reliability of the core system overall. So how do you do that?


A Framework for Corporate Compliance


The simple answer is that your company has to develop its own IT best practice methodology with a QA plan that formalizes how your company handles changes to software systems. Properly implemented, such a plan ensures that any changes to software are thoroughly tested according to pre-defined testing processes and that the testing process is fully documented in audit-ready format. In short, you need to be able to prove that the systems on which you rely for your key management processes have been properly exercised.


This means that, for every system change, you have to be able to show what was tested, how it was tested, who it was tested by, what the results of those tests were, how any defects were handled and re-tested, and how the software was released into the live environment.


It sounds cumbersome, doesn’t it?


But it doesn’t have to be. Original Software can show you how a properly implemented and executed QA plan can not only improve software quality and contribute substantially towards your corporate compliance objectives. It can actually reduce the costs of testing your software by up to 90% - and still increase test coverage.



For more information on corporate compliance visit our whitepapers.


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