(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.
R-PRC (Roelto Pharmaceutical Regulatory Compliance) is a SharpCloud-powered visual compliance application that helps pharmaceutical R&D and manufacturing organisations complete audits, identify non-compliances and improve regulatory performance across global operations. From enterprise level down to site, building, equipment, process, utility and system level, R-PRC gives teams a connected way to assess compliance against 21 CFR Parts 210, 211 and 11, as well as wider regulatory requirements such as MHRA and EU GMP. It enables users to capture findings, link them to regulatory clauses, visualise risk, manage remediation actions and roll site-level information up into a live enterprise compliance view. The result is greater transparency, less manual reporting effort, faster issue resolution and improved support for product quality, efficacy and patient safety.
Complete structured site audits against 21 CFR Parts 210, 211 and 11, with the ability to extend coverage to other regulatory frameworks such as MHRA, EU GMP and TGA.
Track compliance at enterprise, region, site, building, equipment, process, utility and system level, giving users a clear line of sight from strategic status to operational detail.
Log findings during audits in a consistent way, including issue description, impacted area, severity, owner, due date and current status.
Link each finding directly to the relevant regulatory clause or requirement so users can immediately see which regulations are affected and where exposure exists.
Use SharpCloud relationships to connect regulations, findings, assets, sites, actions and evidence, making it easier to understand root cause, impact and remediation pathways. This aligns with Roelto’s broader SharpCloud approach of combining data, commentary and multiple views to simplify decision-making.
Aggregate local audit findings into a live enterprise compliance status so leadership teams can compare sites, identify trends and prioritise action. The current page already highlights this roll-up capability as a core part of R-PRC.
Provide visual dashboards showing compliance status by site, audit category, CFR part, severity and action status, helping teams spot hotspots quickly.
Create and monitor corrective and preventive actions linked to findings, regulations and impacted assets so teams can manage remediation in a traceable way.
Attach supporting evidence such as SOPs, reports, images, validation records and audit notes to findings and actions for stronger audit readiness.
Highlight critical issues based on severity, regulatory impact, recurrence and business risk so teams can focus on the most important remediation work first.
Enable users to filter by site, function, regulation, asset type, issue status or risk level, and interact with the data to investigate concerns in more depth. Roelto’s SharpCloud pages emphasise interactive filtering and multiple dynamically updated views as a key strength.
Support always-current presentations and management reporting without rebuilding slides manually, since SharpCloud views update as the underlying data changes.
Give QA, regulatory, engineering, manufacturing and site leadership teams one place to view, discuss and act on compliance issues together, reducing silos and improving accountability. Roelto’s wider solution pages stress this “one place” and silo-reduction value proposition.
Allow auditors and site users to submit findings through simplified online forms, reducing administration time and avoiding manual consolidation from spreadsheets and emailed reports.
Reveal recurring issues, common regulatory weak points and best-practice remediation opportunities across sites to support ongoing compliance maturity. The current page explicitly references sharing insights and best-practice remediations/corrective actions.
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