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| Requirement and response
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32.1 The system shall provide tools to enter and manage user-configurable lookup or master data.
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32.2 The system shall allow authorized users to configure the specification limits for sample and instrument tests.
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32.3 The system shall allow system nomenclature to be configured to use specific data code sets—such as the International Classification of Diseases or the Healthcare Common Procedure Coding System—or mandated terminology to support regulatory requirements.
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32.4 The system should allow authorized personnel to configure the review and approval of multiple tests at the sample, batch, project, and experiment levels.
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32.5 The system should allow warning and material specification limits to be entered and configured so as to allow their comparison against entered results and determinations for determining whether the results meet those specifications or limits.
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32.6 The system should provide a configurable means of allowing the system to automatically save after each entry to help meet ALCOA, CGMP, and other requirements to contemporaneously record data into records.
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32.7 The system should provide a configurable (based on sample, test, or both) means of permitting electronic signatures for both entered results and approved reports.
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32.8 The system should be capable of providing a complete list of all tests loaded in the system, the amount of material required for each test, and to which location the samples are to be sent for testing.
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32.9 The system shall support configurable laboratory workflows based on appropriate laboratory process and procedure.
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32.10 The system shall allow authorized personnel to assign status values for purposes of tracking sample progress or other portions of laboratory workflow.
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32.11 The system should allow authorized personnel to perform revision control of lookup or master data.
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32.12 The system should provide a means for importing lookup or master data.
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32.13 The system shall be able to define the number of significant figures (i.e., set rounding rules) for reported numeric data.
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32.14 The system should allow calculated limits to be created and managed based on test results and relevant metadata.
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32.15 The system should provide a clear alert or notification upon entry of out-of-specification results.
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32.16 The system shall allow authorized personnel to update static and dynamic data.
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32.17 The system should allow workflow events and status changes to trigger one or more user-defined actions.
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32.18 The system should provide an interface for administrative access that permits approved users to configure the system without extra programming or manipulation of data storage systems.
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32.19 The system should allow administrators to programmatically customize system modules or build calculations within the application.
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32.20 The system should provide a multiuser interface that can be configured to local user needs, including display language, character sets, and time zones.
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32.21 The system should support rules governing electronic records and electronic signatures in regulated environments.
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32.22 The system shall provide a security interface usable across all modules of the system that secures data and operations and prevents unauthorized access to data and functions.
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32.23 The system shall be able to granularly define access control down to the object level, role level, physical location, logical location, network address, and chronometric restriction level for the protection of regulated, patented, confidential, and classified data, methods, or other types of information.
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32.24 The system should support single sign-on such that a user can log in once and access all permitted functions and data.
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32.25 The system shall provide initial login access using at least two unique identification components, e.g., a user identifier and password, or biometric information linked to and used by the genuine user.
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32.26 The system shall prevent the same combination of identification components from being used across more than one account.
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32.27 The system shall allow the administrator to define a time period in days after which a user will be prompted to change their password.
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32.28 The system shall allow the administrator to define a time period of inactivity for a user identifier, after which it will be disabled and archived.
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32.29 The system shall allow the administrator or authorized personnel to configure the allowance or prevention of multiple concurrent active sessions for one unique user.
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32.30 The system shall allow the administrator or authorized personnel to configure approved system use (e.g., "you are accessing a restricted information system," "system use indicates consent to being monitored, recorded, and audited") and other types of notifications to appear before or after a user logs in to the system. These notifications should remain on the screen until acknowledged by the user.
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32.31 The system shall keep an accurate audit trail of login activities, including failed login attempts and electronic signings.
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32.32 The system shall allow the administrator or authorized personnel to define the number of failed login attempts before the system locks the user out.
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32.33 The system shall require at least one unique identification component for additional electronic signings (beyond initial login) during a single, continuous session.
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32.34 The vendor shall provide training materials emphasizing the importance of not sharing unique identification components with other individuals and promoting compliance review for ensuring such practices are followed.
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32.35 The system shall support the ability to initially assign new individual users to system groups, roles, or both.
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32.36 The system shall force a user's electronic signature to be unique and traceable to a specific user's account.
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32.37 The system shall prevent the reuse or reassignment of a user's electronic signature.
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32.38 When the system generates a complete and accurate copy of an electronically signed record, it shall also display the printed name of the signer, the date and time of signature execution, and any applicable meaning associated with the signature. This shall be applicable for both electronically displayed and printed copies of the electronic record.
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32.39 The system should provide a means to migrate static data into the system.
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32.40 The system should provide a means for automatically authenticating if a user's proposed password meets the length, complexity, minimum number of changed characters, and other requirements as configured by the administrator or another authorized system user.
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32.41 The system should provide a means for obscuring authentication feedback as it is entered into the system, e.g., displaying asterisks rather than the typed password or displaying actual typed feedback for a distinctly short period of time before obscuring it.
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