| Founded with a focus on Life Science laboratory applications, over 45% of LabWare’s 1000 plus global customers are in the Life Sciences, operating in regulated laboratory environments. LabWare’s Life Science solutions have evolved from their original emphasis on pharmaceutical R&D and QA/QC to include clinical development, healthcare, and public health applications. Because of a strong focus to delivery of compliant LIMS solutions, LabWare has earned a leading position in laboratory environments subject to regulatory standards such as 21 CFR part 11, ISO/IEC 17025, GLP, GMP, GCP, HIPAA, and CLIA. As illustration of LabWare’s strong reputation in regulatory compliance issues, Vance Kershner, LabWare’s President and Founder, has been invited by the U.S. Food and Drug Administration on multiple occasions to provide training to FDA 21 CFR part 11 LIMS system auditors. LabWare has led the LIMS industry in delivering the features required to meet electronic signature and electronic record standards. LabWare has taken all of the applicable requirements and made sure that all of the possible technical controls are included within LabWare LIMS.
A key element to regulatory compliance is that LabWare LIMS is a fully validated system within our customers' sites. We accomplish this by adhering to the concepts within Good Automated Manufacturing Practices. GAMP defines categories of software that affect the amount and depth of validation work that the customer should perform. LabWare LIMS qualifies as a Category 4 application, as it is a configurable system, where customization is not necessary.
In order to help our customers reach the right level of validation, LabWare provides extensive material such as:
- Example Validation Plans
- Automated Installation Qualification (IQ)
- Operational Qualification (OQ)
- Examples of Performance Qualification (PQ)
- Examples of System Administration SOPs
LabWare will remain at the forefront as new regulations emerge, by having a very active involvement with both customers and regulators. LabWare frequently presents at international conferences and runs training seminars on the issue. LabWare LIMS includes several features designed for regulatory compliance, such as Analyst Certification and Business Rules. These features have value even for customers who are not regulated, because it introduces useful security concepts for any lab. |