 |
 |
LabWare LIMS Quality Statement
Purpose: The purpose of this statement is to establish LabWare's position regarding the compliance of LabWare LIMS with generally accepted practices for development of GXP or Validated software products.
Statement: LabWare LIMS is intended for use in regulated laboratories and is consistent with the principles outlined by GLP, GALP, cGMP, and ISO 9000. LabWare LIMS is designed in accordance with GAMP and ISO 9000-3 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 3 Guidelines define as a "Category 4 - Configurable Software Package".
Development of LabWare LIMS 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 is 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 executes the scripts and signs off on the release to assure that the system does what it purports to do.
Every version of LabWare LIMS has been audited by numerous companies against ISO and GAMP guidelines. There have been no significant findings, and no company has ever not purchased 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. |
|