Regulatory Compliance Associates (RCA)’s Post

Follow the link to learn about how RCA's regulatory compliance consultants helped a pharma client complete a 21 CFR Part 11 gap analysis of their QMS. https://ow.ly/Fepw50Sxq4v

Navigating the complexities of USP standards can be challenging, but we’ve got you covered! Our comprehensive USP Compliance Checklist ensures your processes align with the latest regulations. From quality control to documentation, we've simplified it all. #USPCompliance #QualityControl #PharmaceuticalExcellence #ComplianceMatters

When it comes to the Quality System it is important to always remember that it is not a static entity, it is an ever-evolving linkage of regulatory guidance and expectations and in house practices. To that end the PQS does not stop once you have completed a successful inspection. What is just as important is the mindset of pro-actively identifying issues before they become problems and improving your systems accordingly. To ready more on the two principal approaches that can be taken in this regard visit here; https://lnkd.in/gg8Qkgdf

Learn from RCA's regulatory compliance consultants about data & the amount of CAPA records needed to open an investigation. Link Below ↓ https://ow.ly/k1Ts50QANge

Check out this blog post where we discuss the precise procedures of quality control that a company must follow for regulatory compliance.https://https://lnkd.in/g7QzyVxk

"By developing a robust regulatory compliance strategy, enhancing the QMS, executing critical projects, and building organization capability, Compliance Architects® ensured regulatory compliance and set the stage for future success." - Teresa Gorecki, Practice Lead. Maintaining a regulatory compliance strategy is crucial for any company’s sustainability and success in a rapidly evolving regulatory environment. In this recent blog, gather insights into the key accomplishments that made this strategic overhaul possible, focusing on FDA strategy and response, QMS enhancements, and more! Access it here: https://hubs.ly/Q02QZ3_c0 – #MedDeviceUS24 #GenerisAMD #ComplianceArchitects #medicaldevice #qualitymanagementsystem #QMS

This article must be read by every one in CSV (Irrespective of your exp) and all those who have anything thing to do in regulated space. Let me ask you a question, how many of you can speak for 1 min on difference between Quality and compliance, often using them interchangeably. Charlie Wakeham explains you why they are not same instead one is by product of another. Read it, twice.

This is a masterclass on CAPA management, George! It’s easy to get lost in the compliance details, but you’ve hit the nail on the head—true CAPA excellence comes from mastering a blend of skills, from regulatory knowledge to critical thinking and effective communication. The emphasis on interdisciplinary skills and systemic thinking is spot on. This is the blueprint for not just surviving audits, but driving continuous improvement and real, lasting quality in MedTech. Thanks for sharing these invaluable insights!

The first step to a remediation plan is to do a thorough gap analysis of the regulations/audit findings and the QMS. This is critical to developing the plan for getting back into compliance. Next, adjust the QMS policies and procedures to gain compliance and then execute closing the gaps! Let us custom tailor a solution for you! #compliance #remediation #MEC #customsolutions

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!