GlassHouse Technologies, Inc., the leading provider of independent storage services, today announced the launch of its Data Management Services for biotechnology and life sciences companies. Biotechnology and life science companies face significant operational, financial and regulatory risk from mismanagement of validated computer systems, affecting the approval cycle as they develop new drugs, medical devices and systems. Recent FDA regulatory trends point to increased inspections for quality and compliance of computer systems in these highly-regulated environments, with numerous citations and massive fines against drug companies for insufficient change control, lack of or inconsistent documentation, failure to control and archive good manufacturing process (GMP) information communicated via email, system security problems, and poor GMP training of IT staff.
“Biotechnology and life science companies must use their IT assets to reduce risk and accelerate the time-to-market for new drugs if they are to successfully navigate the drug discovery process, from research through to full FDA approval,” said Carol Rozwell, Vice President of GartnerG2’s Life Sciences group. “How these companies manage and store essential data created during the drug development process becomes critically important in determining which drugs receive approval.”
The GlassHouse Data Management Services include Data Classification, Implementation and Storage Risk Audit. The Data Classification Service is a first step by which biotechnology and life sciences executives can understand the business value of data at every stage of the drug development cycle, from pre-clinical research to New Drug Application (NDA) and electronic submission of the NDA to the FDA. GlassHouse works with clients to define data classes, using GlassHouse’s proprietary Data Classification Model and methodology. Once data classes are defined, GlassHouse recommends steps to store and manage data in a verifiable, cost-effective and efficient manner. Management policies and procedures are developed to ensure that the value of data to the organization is sustained throughout the NDA process. GlassHouse documents the Data Classification process and provides recommendations for improved operations.
Implementation Services provide tactical and strategic improvements to biotechnology and life sciences clients, building off the recommendations and policies developed in the Data Classification phase. Tactical Implementation Services include backup, restore, email archiving, and validation to ensure the availability, verifiability and recoverability of critical data and electronic records. Strategic Implementation Services include development and implementation of storage strategies, based on previously-established Data Classifications, for storage, backup, disaster recovery, and archive operations.
The GlassHouse Risk Audit Service provides periodic quality assessments of the effectiveness of Data Classification and associated policies, implementations, procedures, training and documentation, ensuring on-going data availability, recoverability and system security.
GlassHouse Technologies, Inc., a vendor-neutral provider of IT and storage consulting and services, has developed a methodology that provides policies, procedures and tools to standardize, centralize and simplify the management of data in complex, networked, regulated IT environments. The company’s biotechnology and life sciences clients benefit from improved quality, lower risks associated with data management, and accelerated time to market for NDAs. GlassHouse Data Management Services allow users to measure the quality of their IT operations, ensure compliance with regulatory issues, and align IT and business objectives by improving processes and driving efficiencies.
“GlassHouse does not sell hardware or software, so our biotechnology and life sciences clients trust us to give them unbiased, vendor-neutral guidance as they formulate and implement storage and data management strategies to support business objectives,” said Richard Scannell, Vice President of Strategy, GlassHouse Technologies, Inc. “Our experts understand the issues facing life sciences IT executives in today’s very difficult regulatory and financial environment, and bring a broad understanding of the technologies available to every client engagement,” he added.
GlassHouse at Bio IT World
GlassHouse’s Scannell will be speaking at the upcoming Bio IT World Conference in Boston, March 25-27. Scannell, who will present with Chris Rucker, Global IT Director of Rhodia Pharma Solutions March 27 at 3:15p.m., will address Matching the Value of Data to Storage Systems: Principles of Value at Risk Applied to the Life Sciences. GlassHouse also is sponsoring a Birds of a Feather session at Bio IT World, to be chaired by Peter Ward, an industry consultant and member of the company’s Board of Advisors. The session, Collaboration: A Real World Perspective, is scheduled for March 26 at 5 pm, and will include participation from industry leaders including Andy Ellicott of Infinity Pharmaceuticals, Carol Gloff Ph.D. of Carol Gloff & Associates, and Jonathan Edwards of Gartner G2.
About GlassHouse Technologies, Inc.
GlassHouse Technologies, Inc. provides services that help organizations solve the business problems of enterprise storage. From strategy through deployment and support, GlassHouse partners with clients to transform storage into a strategic advantage. For more information about GlassHouse’s Data Management Services for biotechnology and Life Sciences, call 508-879-5729, visit www.glasshouse.com, or send mail to sales@glasshouse.com.
