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| Regulation, Specification, or Guidance
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Requirement
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ASTM E1578-18 E-11-1
EPA ERLN Laboratory Requirements 4.3.4.1
EPA ERLN Laboratory Requirements 4.8.9
EPA ERLN Laboratory Requirements 4.9.9
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23.1 The system shall capture raw instrument data and metadata either as an electronic file or directly via RS-232 or TCP/IP communication.
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| ASTM E1578-18 E-11-2
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23.2 The scientific data management system (SDMS) should provide a checksum verification of source and destination data and store that verification data in a secure server with controlled access.
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ASTM E1578-18 E-11-1
EPA ERLN Laboratory Requirements 4.3.4.1
EPA ERLN Laboratory Requirements 4.8.9
EPA ERLN Laboratory Requirements 4.9.9
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23.3 The system shall store metadata related to raw instrument data in a database in such a way that the original data generated by instruments for specific samples and tests is easy to retrieve.
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| ASTM E1578-18 E-11-4
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23.4 The system should be capable of capturing a complete and readable copy of original data and any previous versions of modified data in order to maintain the integrity of that data.
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AAVLD AAVLD Requirements for an AVMDL Sec. 4.10.2.3
ASTM E1578-18 E-11-5
EPA ERLN Laboratory Requirements 4.3.4.1
EPA ERLN Laboratory Requirements 4.8.9
EPA ERLN Laboratory Requirements 4.9.9
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23.5 The system should secure raw data such that it can't be deleted and provide version control when data is modified by any user or specific software.
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| ASTM E1578-18 E-11-6
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23.6 The SDMS should provide tools for helping a laboratory achieve the U.S. Food and Drug Administration's defined ALCOA principles.
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| ASTM E1578-18 E-11-7
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23.7 The SDMS shall provide security and access controls for protecting stored data.
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| ASTM E1578-18 E-11-8
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23.8 The SDMS shall record an audit trail for each and every record created and modified, using version control.
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45 CFR Part 164.308
ASTM E1578-18 E-11-9
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23.9 The SDMS shall record an audit trail for each and every record created and modified, using version control.
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