Regulatory Data Integrity
LabWare continues to deploy solutions that meet the challenging regulatory requirements for all the industries we support and we are constantly evolving to ensure we meet the future needs in these ever more data and system centric regulatory environments.
In association with a customer’s procedures and quality systems, LabWare offers a configurable solution that can provide a compliant and validated environment for the functions for which it is being used, providing comprehensive auditing, review functionality and system controls these implementations have been shown to meet the demands of agencies such as FDA, MHRA and WHO in GMP and GLP laboratories.
With the addition of our specific Regulatory Data Integrity module (RDI), many of our customers compliance needs previously achieved through specific system configuration and local processes and procedures, are now available as standardized out of the box functions, with detailed and comprehensive options for controlling auditing, review, electronic signatures, data recording, data importing and more. This in association with our Regulatory Data Integrity Guideline for the Pharmaceutical Industry, available to our customers at implementation, it is easier than ever to build an environment that customers can feel confident in.
LabWare is built to ensure all aspects of the ALCOA+ principles can met by our customers, allowing all data to be captured and maintained appropriately.
A = Attributable
- who performed an activity and when
L = Legible - can all the data (electronic and paper) be read with no ambiguity
C = Contemporaneous - documented at the time of the activity
O = Original - original observations or a certified copy
A = Accurate - no errors or modifications without appropriate documentation
“ + “
Complete - all records exist for the respective sample(s) and batch
Consistent - the sequence of activities and events follow an expected sequence
Enduring - records are recorded on an authorized media
Available - records are accessible over the lifetime of the record (i.e. record retention period)
LabWare’s ongoing focus on these principles has ensured a proven and long track record of our customers successfully meeting regulatory expectations using a foundation of LabWare for their LIMS and ELN needs.