Surety Launches AbsoluteProof for Life Sciences
HERNDON, Virginia, December 1, 2003 – Surety, LLC, a leading provider of data integrity services, today announced the launch of AbsoluteProof for Life Sciences, a new service to support the growing needs of life sciences companies to protect the integrity of their crucial electronic records throughout the entire product lifecycle. The service is built around Surety’s flagship data integrity solution, AbsoluteProof, and is designed to provide life sciences companies and laboratories with intellectual property protection, legal defensibility of electronic records, and compliance with regulatory requirements. The service enables organizations to validate the integrity of an electronic record and notarize each link along the chain of custody—from creation to archive to evidence discovery order.
\"As companies utilize the latest laboratory automation technologies to accelerate their products\' time-to-market, they need to ensure at the same time that they are protecting vital intellectual property and trade secrets, as well as meeting current and emerging regulatory requirements,\" said Jocelyn Young, IDC program manager, U.S. Healthcare IT research. \"It is critical for companies to guarantee that documents are authentic and legally verifiable. The ability of Surety\'s solution to track the date and time of a document\'s creation enables companies to ensure that the document hasn\'t been tampered with since that time.\"
Built on patented technology and secure hashing algorithms, Surety’s AbsoluteProof for Life Sciences is the only long-lived, cryptographically verifiable data integrity service that generates irrefutable evidence of exactly what electronic records were created, precisely when, and that they haven’t been altered since that time. This technology digitally notarizes and time-stamps any electronic record, including computer-generated research notes, LIMS records, design diagrams, device readings, email, and audit logs. It provides critical data to support first-to-invent or first-to-file claims and transforms electronic records into irrefutable evidence to defend trade secrets and patents if ever challenged in a legal proceeding.
“At Surety, we are committed to helping companies in the life sciences community protect their electronic records at every stage, from the conception of an idea, to production, and on to distribution,” stated Tom Klaff, CEO of Surety. “With the proliferation of electronic records in the life sciences market, we have designed AbsoluteProof for Life Sciences to meet the growing need of companies and laboratories to protect the integrity of their electronic records indefinitely and provide a proven solution that will withstand judicial scrutiny.”
Surety’s AbsoluteProof for Life Sciences also helps life sciences companies comply with regulatory mandates such as Title 21 Code of Federal Regulations (21 CFR Part 11). This regulation establishes the criteria under which electronic records and electronic signatures are considered as equivalent to paper records and handwritten signatures. It specifies securing digital audit trails and mandates third-party time-stamps of files. Surety provides the only data integrity solution on the market that can protect the integrity of audit logs within a company’s workflow processes. This represents a critical component of the broader 21 CFR Part 11 regulatory process that the pharmaceutical industry must follow.
Posted: Monday, December 1, 2003