Impact Overview
Third Party Suppliers - Material suppliers, service
providers, and contract research organizations, etc. may be affected by
the requirements within Part 11.
Impact Overview |
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| The Impact of Part 11 on companies falls into the following categories, discussed in more detail on following screens. | |||
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SOPs - Companies may need to change existing procedures or implement new procedures. | ||
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Legacy Systems - These existing, older systems may need to be changed or replaced to become Part 11 compliant. | ||
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New Systems - They must conform to the requirements of Part 11. | ||
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Third Party Suppliers - Material suppliers, service
providers, and contract research organizations, etc. may be affected by
the requirements within Part 11. |
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