Audit Trails
21 CFR Part 11 Support
Anwenderzertifizierung
 | LabWare LIMS is designed from the ground up with the regulated industries in mind, such as the Pharmaceutical and Environmental industries. In order to achieve this, LabWare LIMS has needed to comply with all applicable regulatory guidelines and rulings, such as GMP, GLP, GCP and others (generally grouped together as GxP). In addition, we have ensured that requirements in other regulations such as 21 CFR Part 11, ISO 17025 and various national rulings are completely covered within LabWare LIMS.
LabWare has taken all of the applicable requirements and made sure that all of the possible technical controls are included within LabWare LIMS. For example, 21 CFR Parts 11, 50, 58, 210 211 and 820 are fully addressed within the LabWare LIMS solution. This is also the case with regional bodies such as Europe's EMEA and national bodies such as the Japanese MHLW.
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. |