Regulatory Considerations in Laboratory Informatics
Live Q&A session will immediately follow
Regulatory considerations in laboratory informatics can take many forms, effecting both the vendor and the customer in a multitude of ways. While it is easy to dwell on the negative impact of regulations, everyone would do well to consider the reasons why they exist and the positive impact they can bring. Depending on your regulatory environment, failure to comply with regulations can result in consequences that range from loss of reputation to fines and shutdowns. On the other hand, compliance can result in improved processes, improved reputation and higher market share. These presentations and the discussion that follows will help you to identify applicable regulations, their impact and how to comply with them.

Discussion Topics/Panelists:
Approaching More Meaningful Dialogues on Regulatory Compliance
Donna Lococo
Informatics Technology Leader
PerkinElmer LAS

Common practice may be to approach “compliance” as a bullet item on a feature list, both in terms of an organization’s requirements document and the vendor’s proposal. However, this does all parties a disservice when it comes time to actually implement a system. Clearly, the specific details of context and application are major factors in whether any vendor’s compliance features as implemented actually satisfy the applicable regulatory requirements. This means that the customer, the vendor and the implementers (perhaps a third party) all have to be on the same page relative to their understanding of the regulations and the specifics of how they apply to the system. Given that commercial LIMS are designed for configurability, it is often difficult to comprehend the final design an implementation will take well enough to do this evaluation in advance.

The focus of this presentation will be on advancing the dialogue about compliance, so that all parties involved have a better understanding of regulatory considerations and their consequences at a much earlier point in their system implementation. The gap between technical feature compliance and a compliant system needs to be defined, and both risks and assumptions for all options need to be understood. Some actions involve preparations on the part of the organization, others involve questions about the design and evolution of a vendor’s compliance features. Improving the quality of the early dialogue should result in systems that are technically and demonstrably compliant, while still supporting the other objectives for the system.

Donna managed her first LIMS implementation project in 1984 and inexplicably concluded that it was fun. Transitioning from LIMS customer to LIMS vendor a few years later, Donna worked with customers in a variety of pre- and post- sales roles, with a focus on clear definition of problems and rational, supportable solutions. Currently, she works with the PerkinElmer LABWORKS team on development priorities.

Effectively Defining LIMS System Requirements
Christine Paszko, Ph.D.
VP of Sales and Marketing
Accelerated Technology Laboratories

The first step of any successful laboratory automation project begins with clearly and succinctly defining the technical requirements of the data management system along with the laboratory manager, end-user, IT personnel and all other stakeholder needs requirements. For many projects, this involves the creation of a cross-section of a multi-disciplinary laboratory management team that consists of laboratory management (quality system engineers, project champion, and a regulatory expert), IT and key end-users. This team will work to create flow diagrams that capture the business processes and rules of the organization. Once this process is completed, project managers must assign a priority to the various requirements that the new laboratory automaton solution must address. A second and equally important step is to effectively communicate those requirements, project scope and cost range to the potential vendor partners.

Christine Paszko, Ph.D., is Vice President of Sales and Marketing at Accelerated Technology Laboratories. Among other things, Christine is passionate about working to educate users about LIMS and all the related concerns, which may explain why she took up the task of revising Mary Hinton's book Laboratory Information Management Systems for a second edition.

We Want LIMS to be in Compliance, but which Standards Apply?
Siri H. Segalstad
Consultant
Segalstad Consulting, Norway




There is a jungle of standards out there, so which standards do we use? While an organization might have to comply with a certain set of standards depending upon what the organization does, there is a lot of help to be found in many of the other standards as well. Organizations that do not have to comply with any specific standard are wise to use standards to implement quality thinking and start to trust their IT systems. Standards are not meant to be straight-jackets. They are actually great tools! Choices include pharmaceutical regulations, ISO, environmental (GALP), healthcare, ASTM, IEEE, GAMP guides, and ISPE baseline guides.

Siri Segalstad is the principal of Segalstad Consulting in Norway. She specializes in applying relevant standards to computerized systems, particularly LIMS and CDS, for quality assurance and validation over the entire life cycle of the system. Her pre-consulting career included implementing a LIMS and training the company’s users, which required over 40 series of classes and producing a 250+ page user manual.

Moderator:
John R. Joyce, Ph.D.
LIMS Manager
Commonwealth of Virginia
Division of Consolidated Laboratory Services



John R. Joyce received a Ph.D. in analytical chemistry from Texas A&M University for his work in nuclear and atomic analysis employing the University's 88" variable energy cyclotron. Following this, he spent 10 years with The Dow Chemical Company, primarily with the Michigan Division's Analytical Sciences Laboratory's Instrument Development & Automation Group. He is currently the LIMS manager for the Commonwealth of Virginia's Division of Consolidated Laboratory Services. In addition to writing Scientific Computing's monthly "Online Scientist" column, which explores the latest in computer and Internet applications, John also spearheads the magazine's annual LIMS/Laboratory Informatics supplement and serves on the magazine's editorial board.