Data Integrity module

LabWare has developed and launched a new data integrity module for its enterprise LIMS and ELN solution to help drug manufacturers conform to the FDA draft guidance on ‘Data Integrity and Compliance with CGMP’.

The new enhancement to LabWare LIMS & ELN ensures that companies are able to meet current and proposed regulatory guidance regarding the management of data in temporary memory. New and emerging data integrity standards put forth by the U.S. Food and Drug Administration (FDA), U.K. Medicines and Healthcare Products Regulatory Agency (MHRA), and World Health Organization (WHO), which would require the capture of temporary data in electronic records.

The new features are in addition to LabWare current solution that supports a GxP-compliant audit trail based on a full history of analytical testing, including:

Forced Save during manual result entry, to mitigate manipulation of values in temporary memory.

Disabling manual entry when data is captured directly from instrumentation

Forced reviews of Audit Trail entries when exceptions occur, such as result modification

Checksum generation and checking against data records, to detect manipulation.

Date time of data entry

Electronic Signature and mandatory reason for change