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Is your system validated?

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Is your system used to create, modify, maintain, store, archive, retrieve or transmit patient Protected Health Information (PHI) under Health Insurance Portability and Accountability Act (HIPAA)?

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Does your system use Electronic Records?

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Are Electronic Signatures used?

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Are the records in electronic form created, modified, maintained, archived, retrieved, or distributed by a computer system?

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Are the signatures executed in the system a computer data compilation of any symbol or series of symbols executed, adopted, or authorized by an individual to be the legally binding equivalent of the individual’s handwritten signature?

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Are records protected against intentional or accidental modification or deletion?

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Do you have a strategy defined or documented for the backup, restore and retention process? If so, has it been tested?

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Does your system have access control?

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Do you have policies and procedures to ensure both internal and external security?

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Does your system maintain an audit trail that is readily available for an inspection?

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Does the system ensure that only authorized individuals can use the system?

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Does the system verify that an individual has the authority to electronically sign a record before allowing the individual to do so, or deny access to invalid users?

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Do you have documentation to show that people who use the system have the education, training, and experience to perform their assigned tasks?

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Do you have a Change Control procedure in place for System upgrades?

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Are policies and processes established to certify that an electronic signature is the legally binding equivalent of the signer's handwritten signature?

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Is your system used to electronically sign, electronically approve, or electronically archive data-containing regulatory submission documents for investigational or marketing applications to Health Authorities?

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Does your system have any impact with respect to patient safety or Product Quality or Business Continuity?

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Does your system directly affect the design, conduct, performance, auditing, recording, analyses, and report monitoring of adverse events in clinical studies of investigational products?

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Is your system used for collecting, assessing, monitoring, and reporting adverse events for drug products?

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