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IDIS EE Universal Dissolution Automated Software |
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Open Platform 21 CFR Part 11 Tablet Dissolution Data Management Software |
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FDA 21 CFR Part 11 Compliance
11.10 (d) Limiting access to unauthorised individuals |
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Configurable Centralised Security
11.300 No two individuals have the same name and password. 11.300 (d) Thansaction safeguards to prevent unauthorised attempts to access system. 11.10 (e) Computer generated time stamped audit trail. |
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User Queryable Audit Trail
IDIS EE Audit Trail lists all user activity that creates, deletes or modifies; i.e., from logging on and off to editing of method and data records. |
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Signing and Reporting Signed Records
Once data is acquired in a group with signing rights, any report generated will show the signing status for all records as shown below. |
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