| Carl Turner at Compliance Control reviews the importance of regulatory compliance and suggests methods to keep costs down
Information is the lifeblood of the modern organisation. Management of information is important, but effective cost management is essential. Primarily, businesses exist to make a profit and provide returns to investors or owners. But, with heavily regulated industries such as the pharmaceutical industry, it is sometimes difficult to gain total support within an organisation for compliance and validation of companies’ computerised or automated systems. The perception is that this is a cost to the business and provides very little business benefit, even though companies understand the regulatory requirements to some degree.
Regulatory authorities have taken enforcement action as a result of a failure to comply with the regulatory requirement to validate and maintain systems in a compliant manner. Companies can ensure compliance by initiating various planned activities – but at what cost? And exactly how much ‘compliance or validation’ is actually needed and in what timeframe? Furthermore, if you are involved with gaining or maintaining support for such activities, how do you convince directors or senior management within an organisation that serious funding is required to ensure compliance is built into processes in the first place? Large, medium and small companies within the EU and beyond are faced with similar issues, and several industry led guideline documents from professional organisations as well as regulatory authorities exist, but where do you actually start and how do you manage control more effectively? |
