Originally Published MDDI
January 2004
Regulatory
Outlook
Inventory Form Ideas
Barbara Immel
Immel Resources LLC
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Here are some questions to ask (and to document the answers for) during a records inventory:
• What is the name of the record? Is the record kept on durable media? What is the e-record file name?
• Who is the owner of the record?
• What is the input source (keyboard, Internet, monitoring device, etc.)?
• Is the record used to meet GxP requirements? How would the company describe the GxP use? (What is the record used for?)
• What is the software name (Excel, Access, Word, etc.)?
• What is the storage location? Is the record on the network? Which drive and folder?
• Is there network backup?
• Is the system or record externally accessible? How? (E.g., network, modem, Internet)
• Can data walk? How? (E.g., zip drive, floppy disk, removable hard drive?)
• Has the system been validated? When?
• Does the company confirm electronically that it is doing a GxP task (that something has been reviewed, approved, or rejected) If so, does this action replace a handwritten signature or initials?
• Was the computer system in use prior to August 20, 1997?
• Have there been major changes to the computer system since it was installed? Were those changes reviewed, documented, and validated?
• Are any changes to the computer system—including problems fixed by an outside vendor—now being approved through the company’s change control system?
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