When it comes to public health and safety, quality is the only way. |
MasterControl
If your organization is GxP-regulated or ISO-certified, you are no stranger to the burdens of audit. The regulations and standards that govern your operations change often, and yet you must somehow manage to understand and comply with them – and be able to clearly demonstrate your compliance – at all times.
In the flurry of keeping pace with changing regulatory demands and preparing for impending audits, you might lose sight of the value an audit can bring to your organization. It comes down to a simple yet very important question: if you don’t observe and evaluate, how can you improve?
Audit is a powerful word that seldom invokes positive associations. An audit – by its nature and in any context -- can uncover problems, and problems can warrant penalties, sometimes very serious and costly ones. The headaches involved with preparing for an audit include managing a vast amount of documents, gathering evidence, collecting signatures and signoffs, training employees, coordinating stakeholders, and the list goes on and on.
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