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Research Paper | Regulatory Affairs | United States of America | Volume 11 Issue 12, December 2022 | Popularity: 5 / 10
Automated Audit Coordination and Documentation Systems for Pharmacies
Fayazoddin Mohamad
Abstract: Pharmacies face an increasingly complex regulatory landscape, requiring continuous audits to ensure compliance with authorities such as the DEA, FDA, and CMS, alongside private insurers. Manual coordination of these audits - whether on-site, virtual, or paper-based - is time-intensive, prone to human error, and can disrupt daily operations. This paper presents the design, implementation, and validation of an Automated Audit Coordination and Documentation System (AACDS) tailored specifically for pharmacy settings. Leveraging workflow automation, cloud-based collaboration platforms, and real-time record validation, the proposed system aims to alleviate the burden of continuous audits, streamline data gathering, and maintain robust compliance. We detail the software architecture, data models, and algorithmic checks used to track documentation across inventory records, billing data, and operational workflows. Through a multi-phase evaluation in both urban and rural pharmacy settings (encompassing 23,000 audit records over 18 months), the AACDS demonstrated a 42% reduction in compliance-related human errors, a 35% drop-in audit preparation time, and an overall improvement in staff satisfaction. These results underscore how automation can shape the next generation of pharmacy auditing, mitigating risk, minimizing operational bottlenecks, and reinforcing trust with regulators and payers.
Keywords: Pharmacy Audit, Regulatory Compliance, Workflow Automation, Cloud-based Collaboration, Continuous Audits, DEA, FDA, CMS, Billing Data Validation, Documentation System
Edition: Volume 11 Issue 12, December 2022
Pages: 1416 - 1421
DOI: https://www.doi.org/10.21275/SR221210224204
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