Your business requires compliance and validation. But what does validation mean? At its simplest, validation is a method used to regulate electronic records and signatures. So how did this all begin, and what significance does validation hold today?
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.
21 CFR Part 11 Compliance - How to Ensure You're Covered 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.