FDA Invites InfoStrength to Speak at Public Meeting Regarding 21CFR Part 11
Raleigh, NC - May 26, 2004 - The Food and Drug Administration (FDA) has invited InfoStrength, Inc., the developer of the InfoStrength Smart Enterprise Suite (SES) and a leading regulatory compliance advisor, to speak at the FDA's public meeting to discuss potential changes to 21CFR Part 11.
"The FDA recognizes that there still exists a great deal of confusion about Part 11, even in the face of the most recent guidance," said Ms. Rita Geiger, InfoStrength's President and CEO. "The FDA did not intend Part 11 to be a prescription of regulatory controls. Yet precise checklists, prescribed processes and very specific technological controls have become an unintended industry standard for addressing records and signatures. The FDA is seeking input from regulatory compliance experts regarding how to offer guidance that ensures safety, integrity and quality of electronic records without leaving organizations the impression that they must force fit unintended prescriptions into their business."
"InfoStrength will have the opportunity to recommend ways in which the industry can ensure safety and data integrity that both meet an organization's business needs and maintains responsibility for auditable processes," said Ms. Rita Geiger. "InfoStrength has a great deal of experience helping life science companies bridge the gap between regulations and business by identifying flexible and affordable compliance strategies and the InfoStrength Smart Enterprise Suite of applications that implements and automates those strategies."
Ms. Geiger's life science industry regulatory affairs expertise has made her a frequently sought public speaker. After 10 years of authoring standards and auditing companies for Underwriters Laboratories, Ms. Geiger founded InfoStrength, Inc. in 1997. InfoStrength focuses on helping life science companies address their quality and regulatory needs with Regulatory Affairs advisory services, custom IT development for regulated environments, and commercialized software tools designed to automate quality and regulatory management planning. Ms Geiger has been the featured speaker for numerous FDAnews audio conferences, invited on numerous occasions to conduct Part 11 Training Seminar series for local industry leaders, and most recently she spoke at a BIOCOM meeting in San Diego, California.
About InfoStrength
InfoStrength's unique position represents a market differentiating convergence of regulatory affairs advisory services, custom IT application development capabilities in regulated environments, and the InfoStrength Smart Enterprise Suite (SES). The InfoStrength SES is a configurable, web-based, and easy-to-use suite of applications developed in response to detailed market research in the life sciences industry. The InfoStrength SES delivers software driven quality and regulatory management planning through process, knowledge, and document management in a virtual collaborative environment. InfoStrength's mission is to help life science companies meet their quality and regulatory standards by implementing blended collaborative solutions that satisfy their compliance and quality needs.
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