Alturas incorporates validated software systems and automated workflows that streamline bioanalytical data management while supporting the timely delivery of SEND datasets and standardized eCTD-compliant reports. Independent quality control (QC) review helps verify the accuracy, consistency, and integrity of data generated throughout every study.
From sample receipt through final report delivery, our data management processes are designed to maintain traceability, reduce manual transcription, and support regulatory submissions requiring complete, inspection-ready documentation.
Our turn-around timelines are customized to our sponsor’s needs on a case-by-case basis. Alturas Analytics consistently maintains a capacity reserve for expedited sample analysis and data delivery 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 (GDPs) and compliant with applicable SOPs and regulations.
Every stage of a bioanalytical study generates critical data that must remain accurate, traceable, and secure. Alturas integrates validated electronic systems, standardized workflows, and independent quality review processes to help maintain data integrity throughout the study lifecycle.
Our integrated workflow supports:
These processes reduce manual transcription while helping sponsors prepare reliable documentation for IND, NDA, BLA, and other regulatory submissions.
Bioanalytical documentation plays a critical role in regulatory submissions. Alturas maintains standardized documentation practices designed to support GLP compliance, FDA expectations, and electronic record requirements throughout study execution.
Documentation managed throughout each study may include:
Report templates are standardized and can be personalized to sponsor requirements. To streamline the generation and review of reports, Alturas utilizes StudyReporter (uptodata), an automated and adaptable program designed specifically for compliance. Data is date and time stamped and directly imported from the Thermo ScientificTM Watson LIMS Software (ThermoFisher Scientific) database via locked field codes ensuring that table data cannot be modified.
To manage and distribute all controlled documents, Alturas uses TMS (QSI Technologies), an electronic document management system, to ensure that only current versions for guidance and instruction are in use. All revised or retired controlled documents are archived within TMS; controlled documents prior to using TMS have been scanned as certified copies and archived within the database.
Reliable bioanalytical data depends on more than accurate analytical methods: it requires documented processes that preserve the integrity of every record throughout the study lifecycle.
Alturas’ quality systems support the principles of ALCOA+, helping ensure study data remain Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, and Available from initial sample receipt through final report delivery.
Document management helps ensure study records remain accurate, version controlled, and readily available during sponsor reviews, regulatory inspections, and submission preparation.
Documentation may include study protocols, method validation records, analytical reports, audit trails, quality control documentation, SEND datasets, and final reports prepared for regulatory submission.
ALCOA+ is a framework for maintaining data integrity. It requires records to be attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring, and available throughout the study lifecycle.
Jera A. Kantz, MBA, LATG, RQAP-GLP, serves as the Quality Assurance Manager at Alturas Analytics, Inc. With over 16 years in the CRO industry, she has experience in the laboratory as a Research Associate, and after gaining her AALAS LATG certification, specializing in the Quality Assurance Auditor and Senior Quality Systems Auditor positions. Jera is incredibly passionate about quality assurance. Influencing others to be embrace compliance leading to intuitively generated quality data and ensuring patient safety is her ultimate goal.
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