Accreditation is vitally important for service providers and calibration labs in every industry. Though voluntary, accreditation can often dictate the success of your business and your ability to maintain a steady stream of revenue.
For asset managers, the FDA and Form 483 can often seem like the boogeyman — just more real and with considerably higher consequences. Enduring and passing FDA audits are a regular part of your job, but they never get easier or less nerve-wracking.
Ensuring 21 CFR Part 11 Compliance To properly operate any regulated organization, thousands upon thousands of records are required. For decades, these records were printed and filed - offering physical evidence of the work being done to support compliance with good industry practice.