Alturas incorporates powerful software automation that streamlines processes to ensure the delivery of SEND datasets and standardized eCTD-compliant final reports are on schedule while Quality Control (QC) reviewers ensure the data integrity of the work performed.
Our turn-around timelines are customized to our sponsor’s needs on a case-to-case basis. Alturas Analytics consistently maintains a capacity reserve for expedited sample analysis and data delivery in order to maximize convenience for our sponsors. All reports, paperwork, and data generated at Alturas are reviewed and verified for consistency according to good documentation practices and compliant with applicable SOPs and regulations.
Report templates are standardized and can be personalized to Sponsor requirements. To streamline the generation and review of reports, Alturas utilizes LABIntegrity: StudyDoc™ Report Writing Manager, an automated and adaptable program designed specifically for compliance. Data is date and time stamped and directly imported from the Thermo Scientific Watson™ database via locked field codes ensuring that table data cannot be modified.
To manage and distribute all controlled documents, Alturas uses TMS, an electronic document management system, to ensure only current versions for guidance and instruction are in use. All revised or retired controlled documents are archived within TMS. Controlled documents prior to TMS have been scanned as certified copies and archived within TMS.
Speak with an Expert
Dave Schumacher, RQAP-GLP
Quality Assurance Director
With over 20 years in Quality Assurance, David Schumacher, RQAP-GLP since 2004, oversees the Alturas Analytics Quality Assurance Program. David is an experienced Quality Assurance Professional in FDA regulated environments and auditor in numerous analytical techniques. His emphasis is in bioanalytical (LC−MS/MS and ligand binding) and formulation assays.