LabWare continues to deploy solutions that meet the challenging regulatory requirements for all the industries we support. We are constantly evolving to ensure we meet the future needs in regulatory environments that continue to become more data- and system-centric.
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 used. With comprehensive auditing, review functionality, and system controls, these implementations have been shown to meet the demands of agencies such as the 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 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. With the RDI 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 be 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 resulted in a proven track record of our customers successfully meeting regulatory expectations through their use of LabWare for their LIMS and ELN needs.
LabWare leverages state of the art technology built on a platform that enables seamless modular-based deployment of functionality to customers, leveraging our industry unique approach to ensure the longevity and upgradability of all our customers systems.
This means upgrades are driven by the customers desire to increase functionality, and not driven by changes in the technology itself, ensuring value and avoiding non-value added system upgrades.
LabWare’s unique approach to Laboratory Automation has ensured its position as the world's #1 LIMS by enabling us to be the most functional, configurable, easily integrated solution, delivering the most value to customers with the robust and future focused solution that they need.
LabWare LIMS and LabWare ELN are intended for use in regulated laboratories. Our QA processes are designed to ensure compliance with its specification and to be consistent with the principles outlined by GLP, GALP, cGMP, and ISO. LabWare LIMS and LabWare ELN are designed in accordance with GAMP and ISO 9001:2000 guidelines. They operate in such a way that:
Development of LabWare LIMS and LabWare ELN uses a fully documented spiral lifecycle development methodology. LabWare’s quality system consists of standard operating procedures (SOPs) that govern the entire development lifecycle and online systems that control and document all software changes. The quality system is continuously improved and audited extensively by LabWare’s customers and our internal ISO-trained auditor.
We extensively test LabWare LIMS and ELN prior to each software release and utilize formal test plans and scripts. A "traceability matrix" is used to cross-reference functional requirements to user documentation and test plans. An external validation consultant reviews executed scripts and signs off on the release to assure that the system does what it purports to do.
Every version of LabWare LIMS and LabWare ELN has been audited by numerous companies against ISO and GAMP guidelines, which reduces any validation concerns our customers have had. In addition, no LabWare customer has been unable to validate the installed system.
LabWare is open to audits by any customer or regulatory agency, and all quality system documentation is available for inspection and review.
