(Roelto – Pharmaceutical Regulatory Compliance)
R-PRC provides you a visual way to complete your regulatory audits against the FDA CFR 210/211/11 codes or other counties regulators such as the MHRA, EU or TGA in a simple and easy way so you can see non compliances immediately, which you can share to gain insights and best practice remediations/corrective actions. Enable your regulatory and operational teams to enhance their compliance status to support product quality, efficacy and patient safety.
If you have to collate audit reports and information from various sites, teams or functions and consolidate this information into an overall regulatory compliance status, R-PRC can help you reduce the non-added value administration time by providing your compliance auditors and staff an online form to complete, which when submitted updates your risk based assed equipment, systems and processes.
No more updating spreadsheets, presentations or reports and emailing them. All your dashboard views and presentations are updated, ensuring everyone has the most current status to help remediate and prevent the non-compliance reoccurring within your business.
Feel free to interact with one of our R-PRC apps, CFR 211 Audit. Just point and click to navigate, filter and discover more.
Typically you will have multiple sites located around the world with various buildings, processes and systems developing or manufacturing your pharmaceutical products. Keeping track of your compliance status at a building, site, regions to your overall organisational status is challenging.
R-PRC is online service, enabling you to capture audit findings and roll that up to create an enterprise compliance status.
Click the R-PRC icon to learn more.
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“SharpCloud is a very good tool. You can organise your work, projects, ideas, strategy, roadmap whatever your organization is working on or planning to. In organisations that are widely spread and across the globe it is the perfect collaboration tool.”
Dimitris Chatzgoolou
International IT Manager