Bratton LabWorx’s Post

What are Simulated Audits? These audits ensure a lab’s compliance and ease staff anxiety around pending regulatory inspections. They are also known as mock inspections! Learn more about simulated audits on our website at https://lnkd.in/gJyhCnBu

Also known as mock inspections, simulated audits are intended to help labs prepare for actual (usually unannounced) inspections from regulatory agencies such as CAP. Learn more about simulated audits at https://lnkd.in/gJyhCnBu

A CAPA is a comprehensive investigation generated to address a systemic quality incident and is mandatory in resolving/preventing the issue from recurring. In order to have an adequate CAPA process, the approach must be vigorous, effective, and beneficial in addressing any critical non-compliance that may have occurred As per the FDA, “The purpose of the corrective and preventive action subsystem is to collect information, analyze information, identify and investigate quality problems and to take appropriate and effective corrective and preventive action to prevent recurrence”.

Unexpected visit from a regulatory inspector caught you and your team off guard? We have the tips and lists you need to remove that anxiety. Join the conversation: https://hubs.li/Q02t4pYq0 #FoodManufacturing #FDA #Audit

Compliance with 21 CFR Part 11 & Annex 11 is a collaborative effort between you and your environmental monitoring system.  Join Senior GxP Regulatory Compliance Expert Paul Daniel on your own time, and learn how to meet the operational requirements of GxP-regulated organizations by ensuring that systems incorporate risk-reduction features.  Watch today! 

Compliance with 21 CFR Part 11 & Annex 11 is a collaborative effort between you and your environmental monitoring system.  Join Senior GxP Regulatory Compliance Expert Paul Daniel on your own time, and learn how to meet the operational requirements of GxP-regulated organizations by ensuring that systems incorporate risk-reduction features.  Watch today! 

Thank you Mary Hoffman for choosing this topic for the Apr 26, 2024 FSMA Friday webinar. These events can create lots of anxiety. Expect the discussion to cover these topics, amongst others: ✅ Critical documents that should be prepared ✅ Management and training processes to ensure an "always-ready" culture Employing the right tools can also help keep anxiety to a minimum. SafetyChain customers utilize our industry leading platform to support any audit program. GFSI? FDA? USDA? Customer specific? YES, YES, YES, YES! #auditready #qualitymanagement

Compliance with 21 CFR Part 11 & Annex 11 is a collaborative effort between you and your environmental monitoring system.  Join Senior GxP Regulatory Compliance Expert Paul Daniel on your own time, and learn how to meet the operational requirements of GxP-regulated organizations by ensuring that systems incorporate risk-reduction features.  Watch today! 

Compliance with 21 CFR Part 11 & Annex 11 is a collaborative effort between you and your environmental monitoring system.  Join Senior GxP Regulatory Compliance Expert Paul Daniel on your own time, and learn how to meet the operational requirements of GxP-regulated organizations by ensuring that systems incorporate risk-reduction features.  Watch today! 

Compliance with 21 CFR Part 11 & Annex 11 is a collaborative effort between you and your environmental monitoring system.  Join Senior GxP Regulatory Compliance Expert Paul Daniel on your own time, and learn how to meet the operational requirements of GxP-regulated organizations by ensuring that systems incorporate risk-reduction features.  Watch today!