Validation Case Studies
LabAnswer's deep knowledge of laboratory applications reduces the total cost of validation/implementation. LabAnswer understands the challenges FDA-regulated companies face in keeping up to date with changes in the industry, implementing new technologies and maintaining compliant systems.
Our clients rely on us to leverage our multi-system and regulatory experience along with our methodologies to deliver efficient solutions that support their program objectives, that are practical from a business perspective, and that are defensible to regulatory agencies.
A specialty pharmaceutical client's rapid growth required that processes and systems to manage and review sample test results, release inventory, and manage certificates of analysis be reengineered and automated to support quality control and regulatory compliance. LabAnswer implemented a SQL*LIMS system and integrated into the existing environment to achieve the business goals. The implementation included an interface with the client's JDE Enterprise Resource Planning system and provided the throughput and scalability necessary to insure quality and FDA compliance.
A major pharmaceutical company was under a challenging deadline to implement and validate a Disaster Recovery environment for their production TotalChrom system. LabAnswer leveraged existing documentation, revised outdated documents, provided quality and project management support, and provided a team to manage and execute the qualification test cases, completing the project on time and under budget.
A major pharmaceutical company needed to validate a 21 CFR Part 11 compliant system while adhering to newly defined corporate SOPs and meeting existing project deadlines. Even with unexpected complications, LabAnswer's knowledge and experience with SOPs, laboratory informatics, validation, and their ability to build a highly qualified team and manage it effectively led to completion of the project on schedule.
An international HIV research organization needed to install and validate a Laboratory Information Management System (LIMS) to support clinical studies and global sample inventory in AIDS research. LabAnswer guided the design, implementation and validation of the LabWare LIMS, which facilitated partnering with a tier one pharmaceutical company.