Pharmaceutical Lab & Informatics

Optimizing and integrating laboratory and informatics systems is a difficult and complex undertaking. We help clients achieve laboratory excellence by providing expert compliance services in the areas of LIMS, ELN, SDMS, CDAS, laboratory equipment and practices, including computer system validation, business analysis and definition, lab network support and lab operational support.

• We perform a thorough review of the laboratory systems and their associated data paths to determine alignment to compliance and data integrity standards.
• We provide experienced validation resources needed to create a compliant validation software package in alignment with the client SDLC (System Development Life Cycle Documents).
• Our leaders guide validation efforts through the many compliance stage gates of the project lifecycle.
• We institute a structured approach to extracting and aligning business process steps across a client’s workflow to provide a map of requirements and system steps necessary to create a working harmonized solution.
• We create a structured compliant laboratory space and provide clients with a fully functional networked laboratory ready to collect data.