"…a strong understanding of … possible approaches to a LIMS/global validation effort"
A Leading Biotechnology Company
Meeting Compliance Mandates
Regulatory Compliance Strategy
LabAnswers validation practice addresses the regulated industry’s need to establish documented evidence that provides a high degree of assurance that computerized systems will consistently perform as intended in their operational environment according to predetermined specifications and quality attributes. Our domain expertise facilitates the creation of a cost effective strategy that leverages the software vendors efforts, the implementation deliverables and the client policies to provide a solid compliance strategy.
LabAnswer understands the challenges regulated companies face in keeping up-to-date with the on-going changes in the industry, implementing new technologies and maintaining compliant systems. Meet your regulatory requirements by utilizing a team that fully understands the regulations, risk assessments and is focused on your specific laboratory informatics applications.
Validation Strategic Planning
LabAnswer's validation approach gives you "peace of mind" by helping you understand the risks, allowing you to make intelligent business decisions on how to use your validation resources. We take the time to understand your strategic business needs and adjust our validation services to meet them in accordance with current regulations. We can perform a risk-based assessment of the system requirements to determine the level of validation that is required. Our team will customize the validation scope, always explaining to you the associated risks and the criticality and complexity of those risks. We collaborate with you on the approach that best fits your needs and provide you with a service that is both practical and justifiable.