21 CFR PART 11: Complete Manual for Compliance Success

FDA inspectors are ever increasing the number of inspections where they include Part 11 as a part of the scope or THE scope of the inspection. The trends and reports are showing that the FDA inspectors are focusing on electronic signatures and electronic records as more and more companies are implementing systems and technologies to […]

Software vendor qualification

Since many of the present generation’s medical devices are run by software; a practical approach is to have this software validated. This validation, also known as software vendor qualification, is a means to ensuring that the software, the heart of the medical device, is compliant with set standards. The principles of this qualification are set […]

Excel spreadsheet validation to eliminate 483s

One of the basic issues for organizations in the regulated area is to carry out Excel spreadsheet validation to eliminate 483s. Why is this so? The FDA requires validation of electronic records, and this is a key requirement. The FDA has its set of regulatory requirements set out in 21 CFR Part 11. This code […]