In Highly Regulated Industries, Your Labeling Must Speak For Your Product – Compliance Is Non-Negotiable!
Computerized systems validation is essential for medical device and pharmaceutical manufacturers. Here, Beth Peckover, VP Global Delivery at Kallik, pinpoints the three areas businesses need to get right to ensure computerized systems used for labeling meet all GxP requirements set out by industry regulators.
The FDA explains that medical device manufacturers must incorporate several elements in their quality assurance (QA) program that relate to labeling in order to meet the GMP requirements of Quality System regulation. The potential damage to consumers and company reputation due to a recall from not meeting these standards is extreme – patient safety can be put at risk and businesses shut down because of incorrect labeling.