LabWare Statement of Conformity
Purpose: The purpose of this statement is to establish LabWare’s position regarding compliance of LabWare LIMS and LabWare ELN with its specification and generally accepted practices for ownership of GXP or Validated software products.
Statement: LabWare LIMS and LabWare ELN are intended for use in regulated laboratories. Our QA process 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 and operates in such a way that:
- allows configuration instead of programmed customizations;
- contains internal configuration-change-control auditors;
- all raw data modifications are audited;
- configuration can be centrally maintained;
- permits language and terminology translations without compiling source code;
- supports database configuration changes without compiling source code;
- conforms to the requirements for a "Closed System" as defined by 21 CFR Part 11;
- GAMP 5 Guidelines define as a "Category 4 - Configurable Software Package",
Development of LabWare LIMS and LabWare ELN uses a fully documented Spiral Life-Cycle development methodology. LabWare’s Quality System consists of Standard Operating Procedures (SOPs) governing the entire development life cycle and on-line systems that control and document all software changes. The Quality System is continuously being improved and is audited extensively by LabWare’s customers and our internal ISO trained auditor.
LabWare LIMS and LabWare ELN are extensively tested prior to each software release. Formal Test Plans and Scripts are utilized. 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. No company has decided not to purchase the software because of validation concerns. 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.