ID Number: G00250979




Accelrys Pushes Further Into Compliant Manufacturing With a New LIMS
21 March 2013
 
Michael Shanler  

Accelrys's launch of a laboratory information and management system demonstrates the convergence of lab, quality and manufacturing processes in life science manufacturing. But deployments may need some time to realize ROI.














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News Analysis

Event

On 18 March 2013, Accelrys announced the launch of the Accelrys laboratory information and management system (LIMS), part of the Accelrys Process Management and Compliance Suite.

Analysis

This is the first time that a lab informatics vendor has developed a process-centric LIMS with automated compliance features. We expect later versions of the LIMS to be more effective than the initial offering, and over time Accelrys' efforts could benefit enterprises working within complex and regulated manufacturing environments. Traditional LIMS vendors’ sample-centric tools have proved to be inflexible and difficult to validate. Manufacturers require better process-centric approaches and automated compliance tools for laboratory operations.

Merging with Symyx in 2010 helped Accelrys become a leading provider of scientific informatics software for R&D. The LIMS also draws on capabilities that Accelrys gained through its 2012 acquisitions, including:

  • Velquest, which provides a Lab Execution System (LES). As one of the leaders in Good X Practice (GxP) electrionic lab notebooks (ELNs), Velquest was strong in lab execution, instrument connectivity, electronic batch records, and system integration into third-party LIMS, ERP quality modules and other business systems. Velquest gave Accelrys depth in the manufacturing space.
  • Aegis Analytical, which provides process informatics solutions to bolster process reliability and quality. Its capabilities, though not yet fully integrated, could enable Accelrys to enter the operations intelligence and manufacturing process validation market.
  • Vialis, a lab informatics service firm with customers in Europe.

Accelrys' acquisitions and Accelrys LIMS enable customers in GxP and associated regulated manufacturing environments to obtain more tools through a single vendor and to develop insights between lab, quality and manufacturing groups. We expect Accelrys will spend at least 12 months integrating its acquisitions, disseminating LES know-how and creating solutions that fully leverage its capabilities. If Accelrys successfully manages this transition, manufacturers should be able to use the Accelrys LIMS modules for 75% of common LIMS processes, including:

  • Work requests
  • Stability and environmental monitoring
  • Inventory and sample management
  • System metrology and calibration.

A workflow-editing tool and built-in compliance check feature also offer the ability to generate qualification reports. Nevertheless, the LIMS offering likely doesn’t cover all of an enterprise's needs and will require customization. Also, Gartner clients report that the decline in the level of execution by informatics vendors across the entire industry has affected total cost of ownership and ROI.

Recommendations

Accelrys customers:

  • Consider the add-on LIMS capability when the Accelrys LES is already in place.
  • Evaluate the tradeoffs in pricing and capabilities when using a single lab informatics vendor rather than many vendors.
  • Factor in the level of execution in your region while determining the overall value.
  • Determine the level of support required for late-stage GxP environments and model the ROI for improving process-centric validation activities.
  • Take a more end-to-end enterprise view on the value of laboratory informatics.

Non-Accelrys customers:

  • Determine if a process-centric validation approach creates more value than current sample-centric approaches.
  • Evaluate the risks and advantages of using aggregated Accelrys technologies rather than existing LES, ELN, LIMS and process intelligence solutions.
  • Ask your current supplier how the new product affects existing contracts, support and product development, and for details of any plan to improve compliant-manufacturing support.

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