Compliance with regulations has always been a reality of business. Now, compliance more than ever connects directly to market performance.
Regulations have seemed to multiply over time. All public companies that trade on U.S. markets must comply with the FDA requirements. If they trade in Europe they must comply with European legislators.
The list is long and the regulations complex, regardless of your industry. Failure to comply now bears more serious penalties than ever, including the loss of corporate integrity and shareholder confidence.
For this reason, Validation Online Newsletter will always try to keep you abreast of the current specific compliance requirements. Many solutions are to be found in the approach to complex compliance requirements and from the multiple systems involved.
Write and Detail Those Procedures.
Well written procedures are important tools, and, like any tool, have value only when properly used. For example, the blueprints that a carpenter follows when building a house are his written procedures, his controls. If he doesn't follow his blueprints, the finished house won't turn out as planned. Likewise, your written procedures provide you with detailed step-by-step instructions for executing or controlling the important parts of your business. Each step must be written in a clear and logical sequence. All steps should lead to our final goal - a safe and effective product. Another way you might think of written procedures is as a roadmap, which when carefully followed, help you avoid wrong turns - wrong turns that could put you on the road to mix-ups, errors, and recalls.