What is required from electronic systems for documenting transactions?

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The requirements for electronic systems used in documenting transactions are focused on ensuring that there is a reliable record of pharmacy activities that can be easily accessed for verification and compliance purposes. In this context, having a hard copy detail of transactions and refills for the past two years serves as a crucial backup for electronic records. This provides a tangible audit trail that can be used in the event of a system failure, cyber incident, or other circumstances where electronic records may not be accessible or verifiable.

Moreover, regulatory bodies often mandate that pharmacies maintain hard copies of certain records for specific periods to ensure accountability and transparency in the dispensing of medications. The two-year requirement aligns with many state and federal regulations, which emphasize the importance of retaining records that can prove the transaction history of controlled substances and other critical pharmacy operations.

While having digital backups, real-time updates, and monthly sales reports are important components of an effective electronic record-keeping system, they do not fulfill the specific regulatory requirement that necessitates keeping hard copies for a defined duration, which is crucial for compliance and potential audits. Thus, maintaining hard copies of transactions/refills for two years addresses these compliance needs comprehensively.