Planned and unplanned audits are common in the industry. Companies that don’t meticulously maintain accurate records tend to struggle when an unplanned inspection occurs. Organization’s struggle to find the necessary details to justify deviations, out of spec procedures, batch approvals.
Multiple failures are drug safety , labelling errors, incomplete records, CAPA failures, Equipment issues and many other area where human intervention is higher.
We support Organizations to make them futuready for any unannounced inspection from Regulatory Bodies, making CFR 21 part 11 compliant our team of expert Analyze Identify, Design Compliance based Process Management Systems. Our centre of excellence approach ensures right first time right every time culture , enabling the pharma sector to ensure their regulatory compliances from raw material to final product delivery.
