Laboratory Computerized Support Management

Laboratory Computerized Support Management

Laboratory Computerized Support Management

ALTEN delivered end-to-end lab software and data infrastructure support for one of the world’s top healthcare firms. From vendor system integration to validation and license lifecycle management, ALTEN kept the lab running clean, compliant, and data-driven.

A leading global healthcare company, specializing in pharmaceuticals, vaccines, and consumer healthcare, relies on ALTEN Technology for comprehensive laboratory computerized support management at its Rockville, MD R&D center. This extensive project involves ALTEN Technology providing crucial technical assistance to scientists for both new and existing laboratory software and hardware systems, specifically for data analysis and experimental work. The scope of ALTEN Technology’s engagement is broad, encompassing project management using Agile and waterfall methodologies, conducting gap analyses and feasibility studies, creating essential documentation like URS and functional specifications, managing change, and writing technical documentation for validation. Additionally, their responsibilities extend to the full lifecycle management of computer hardware, software, and licenses, ensuring seamless laboratory network and instrument connectivity, managing scientific software, handling vendor and supplier relationships, implementing data integrity solutions, commissioning computerized lab systems, and providing support for database setups (SQL, Oracle) and big data solutions, alongside lab automation initiatives. ALTEN Technology adds significant value by enhancing production process quality through extensive software validation and data storage solution processes. Their deep technical knowledge and continuous training enable efficient project delivery, utilizing key technologies such as DeltaV, OneCDS, MassSpec, Agilent OpenLab, and adhering to standards like GAMP 5, ALCOA+, and 21 CFR 11. This substantial work package, active since 2018, is managed by a 20-person team in the USA.