Who Else Needs Paperless Chain of Custody?

Data Unlimited International, Inc., Maryland, USA - August 7, 2001 - DUII successfully delivered a customized Starfruit DNA Laboratory Information Management System (LIMS) to the Crime Laboratory of Baltimore City Police Department (BCPD). The delivery included chain of custody, scientist proficiency, security management, test results and forms, sample tracking, peer review, and export of case reports to the State's Attorney's Office for the Accelerated Drug Analysis The Accelerated Drug Analysis and Case Disposal Program requires that the laboratory complete the test and analysis of the drug evidences in less than 12 hours and the state attorney should dispose of the case within 24 hours of arrest. Starfruit DNA LIMS uses Smart Card Technology of Samsung Data Systems America, Inc. (SDSA) to systematically generate chain of custody. When laboratory scientists of BCPD use smart cards to obtain access to samples, to witness transferring samples, and to review laboratory processes and reports, Starfruit DNA LIMS generates chain of custody in the background that is transparent to Starfruit users by recording who, where, when, what, and why the samples are transferred. The chain of custody is a no-human-intervention document. Starfruit DNA LIMS directly exports the chain of custody and casework documents to the State Attorney -- again no-human-intervention. Starfruit DNA LIMS eliminates errors such as incomplete chain of custody, wrong tests, scheduled procedure not performed, no testing chronology, no details of supervisory oversight, no signature, wrong samples used to test, samples contaminated or damage, improperly stored/handled, sample lost, test failure and lost/erased casework documents. Email to get Smart Card white paper.

DUII Will Present at smallTalk2001: LIMS Design Driven by Standard Operating Procedures

Data Unlimited International, Inc., Maryland, USA - June 6, 2001 - 

DUII was proudly accepted by the Association for Laboratory Automation (ALA) to present a Laboratory Information Management System (LIMS) design and method that integrates electronic Standard Operating Procedure (SOP) to laboratory process at smallTalk2001, Association for Laboratory Automation,  from August 29 to August 31, 2001 in San Diego, California. smallTalk2001 is dedicated to microfluidics, microarrays, and bioMEMS technologies and their applications to the problems of chemical and biochemical  analysis and characterization.

The presentation will center in the methodologies of electronic SOPs and the technologies used to realize the methodologies. Protocol management is a common part of all LIMS applications. The  way exists to extend the flexibility of a protocol management mechanism, which generally is directed to the study of the specified sample, to the entire computer system. These new methodologies are based on the concept of a SOP  meaning that an instruction set electronically stored to include text description, forms, charts, plans, and computer directives in a predefined sequence.

Click to gain access to the abstract of the methodologies.

Headline: DUII Offers Software/Databasing Solution to CODIS/Parentage Genotyping Laboratories

Data Unlimited International, Inc. (DUII), Maryland, USA - 4/5/2001 -

CODIS/Parentage genotyping laboratories can have automated computer environment to process deoxyribonucleic acid (DNA) casework starting from accepting DNA samples to generating electronic data to send to COmbined DNA Index System (CODIS) of Federal Bureau of Investigation (FBI) and/or to deliver test results to the submitting clients.  Important calculation feature is the estimation of parentage index (PI) based on the lookup table CODIS FREQUENCIES: FBI and the Formulas for Paternity Index and RMNE for Simple Codominant Systems. This is the first client server application to automate DNA casework that tracks chain of custody, monitors laboratory process using electronic Standard Operating Procedure (SOP) and concludes the casework by CODIS electronic data and Parentage Index calculation.

The Combined DNA Index System (CODIS) program provides software and support services to enable state and local laboratories to establish databases of convicted offenders, unsolved crime scenes, and missing persons. CODIS allows these forensic laboratories to exchange and compare DNA profiles electronically, thereby linking serial violent crimes, especially sexual assaults, to each other, and to identify suspects by matching DNA from crime scenes to convicted offenders

Commonwealth Biotechnologies, Inc. (CBI www.cbi-biotech.com) awarded a contract to DUII to deploy this computer environment. Founded in 1992, CBI is located in Gateway Centre, 601 Biotech Drive, Richmond, Virginia 23235 (1-800-735-9224).  CBI occupied this 32,000 square foot facility in December 1998 and currently employs a staff of 48 including twelve doctoral scientists.  CBI provides comprehensive research and development services to more than 1,900 private, government, and academic customers in the global biotechnology industry.

Headline: DUII Signed The Joint Software Development Agreement with BRT Laboratories, Inc.

Data Unlimited International, Inc. (DUII), Maryland, USA - 2/22/01 -
DUII signed the Joint Software Development Agreement with Baltimore-based BRT Laboratories, Inc. (www.brtlabs.com) to re-engineer BRT's intelligent calculations of parentage index, sibling, mixture, alternatives and to integrate to DUII's Starfruit DNA®, (http://www.duii.com/lims.htm) an improved Laboratory Information Management System (LIMS) using Standard Operation Procedure (SOP)-driven Digital Network Architecture (DNA) to automate the electronic record management.

BRT is a wholly owned corporation of Baltimore Rh Typing Laboratory (same address) that was established in 1945. During the first year of operation, testing for the purpose of the establishment of paternity was added as a service. Since then, the organization has continually upgraded its technology to remain at the forefront of identity testing services for the purposes of paternity, immigration and forensics. BRT currently operates a state-of-the-art laboratory that provides forensic testing for various organizations within the State of Maryland as well as private testing for attorneys throughout the United States.

The final product of integrating BRT's methods and calculations for interpreting DNA test results with DUII's Starfruit DNA® management system will be complete automation: From sample acceptance to case processing, including documentation of chain of custody, DNA interpretation and probability determination, reporting and customer billing. The final product will conform to the regulations set by Food and Drug Administration (FDA) 21CFR11 (http://www.fda.gov/ohrms/dockets/dockets/dockets.htm) and accreditation programs of American Society of Crime Laboratory Directors (ASCLD) (www.ascld.org) and American Association of Blood Banks (AABB) (www.aabb.org).

Headline: DUII Won the contract of Baltimore City Police Department to implement LIMS project

Data Unlimited International, Inc. (DUII), Maryland, USA - 2/22/01 -
Baltimore City Police Department (www.baltimorepolice.org) awarded a contract to DUII for the Laboratory Information Management System (LIMS) for its Drug Unit of the Laboratory Division.

DUII proposed to customize its patent-applied software, Starfruit DNA® Laboratory Information Management System (LIMS) (http://www.duii.com/lims.htm), to fulfill the project technical specifications and the requirements of the Accelerated Drug Analysis and Case Disposal Program.

The Accelerated Drug Analysis and Case Disposal Program requires that the laboratory complete the test and analysis of the drug evidences in less than 12 hours and the state attorney should dispose of the case within 24 hours of arrest.

The technical specifications include the system response time to expedite the electronic record transmission, export/import and data interface; instrument interface, electronic forms, electronic signatures, chain of custody, network implementation, training, documents, reporting, quality assurance of the laboratory process and tracking of the personnel's performance.

Headline: Chief Information Officer Solutions & Partners 2(CIO-SP2) Award

Data Unlimited International, Inc. (DUII), Maryland, USA - 2/22/01 -
DUII won the CIO-SP2 contract of National Institute of Health (NIH) (http://nitacc.nih.gov) as a sub-contract to Federal Data Corporation (www.ciosp2fdc.com). The CIO-SP2 contract provides Information Technology hardware, software, systems, and services in support of IT solutions within NIH and other Government Agencies. DUII will perform the task areas: IT Operations & Maintenance, Critical Infrastructure Protection & Information Assurance, Clinical Support, Research & Studies and Software Development.

Specifically, DUII will market Starfruit DNA®, electronic signatures, smart card technology and Food and Drug Administration (FDA) 21CFR11-awareness to NIH and Government wide agencies. Starfruit DNA® is an improved Laboratory Information Management System (LIMS) that enhance the quality assurance and control using the patent-pending business method, Standard Operating Procedure (SOP)-driven Digital Network Architecture (DNA). SOP DNA is an encyclopedia of electronic SOP that is integrated to the laboratory processes so that protocols, processes and analyses are monitored, guided, and tracked.

DUII will introduce the electronic signatures and smart card technology to enforce the authentication, identification and signing off documents.

DUII will introduce the methods to conform to the requirements of FDA 21CFR11 (http://www.fda.gov/ohrms/dockets/dockets/dockets.htm) Electronic Records; Electronic Signatures.

Headline: DUII Established The Strategic Alliance with Protech Pharmaservices Corporation (PPC), Taiwan

Data Unlimited International, Inc. (DUII), Maryland, USA - 2/22/01 -
DUII established the alliance with PPC to market DUII's software product, Starfruit DNA ® (www.duii.com/lims.htm), to the bioscience industry of Taiwan.

Starfruit DNA® is a key improvement technology to the traditional Laboratory Information Management System (LIMS) by controlling and assuring the quality of the laboratory processes using electronic Standard Operating Procedures (SOPs). The mission of the alliance is to facilitate and educate the bioscience industry of Taiwan to build a regulation-compliant computational infrastructure.

PPC (www.ppccro.com) will use Starfruit DNA® to support the its pharmaceutical contracting services including bioanalytical development, clinical trials, pharmacokinetics, pharmacoeconomics, regulatory support in the Asia-Pacific region. PPC has branches and other alliances in Japan and USA. PPC is the first accredited laboratory in Taiwan by the Government.

Headline: DUII Signed The Alliance Agreement with Samsung SDS America (SDSA) Inc.

Data Unlimited International, Inc. (DUII), Maryland, USA - 2/22/01 -
DUII established the alliance with the missions to market the Information Technology (IT) products and services of SDSA (www.samsungsdsa.com).

The first accomplishment of the alliance is that DUII integrated SDSA's smart card technology to DUII’s Starfruit DNA® Laboratory Information Management System (LIMS) (http://www.duii.com/lims.htm). The results enable Starfruit DNA® to assist the laboratories in being compliant with the regulation of the electronic records and electronic signatures such as Food and Drug Administration (FDA) 21CFR11 (http://www.fda.gov/ohrms/dockets/dockets/dockets.htm) and accreditation programs of American Society of Crime Laboratory Directors (ASCLD) (www.ascld.org) and American Association of Blood Banks (AABB) (www.aabb.org).

Starfruit DNA® users will use the smart cards to log in the application and use smart card to sign off and approve their documents, forms, Standard Operating Procedures (SOPs) and laboratory processes.

Smart Cards are plastic cards that contain an integrated circuit chip or computer chip.

A single smart card can be used for identification, secure access to the computer networks, storage of medical or training records, and financial applications known as e-commerce.

Smart cards can store up to 64K worth of information. Most smart cards in use today have the capacity to store 8K or 16K. Smart cards may be 'contact' cards or 'contactless' cards. Contact cards work by being inserted in a smart card reader. Contactless cards can work by being waved over a reader.

Headline: DUII Was Awarded FSS GSA Award GS-35F-0045L

Data Unlimited International, Inc. (DUII), Maryland, USA - 2/22/01 -
DUII is able to provide its products and services to the Federal Government agencies by the awarded GSA schedule. DUII has the commercial off-the-shelf (COTS), Starfruit DNA® (http://www.duii.com/lims.htm) Laboratory Information Management System (LIMS). Starfruit DNA® is software, database and network. Starfruit DNA® tracks samples, inventory, laboratory process, task assignment and parentage index calculation. The compelling features of Starfruit DNA® are its electronic Standard Operating Procedures (SOPs) that monitor, guide and quality assure the laboratory processes from the beginning acceptance of the samples to the end of the laboratory analysis and complete the electronic record management with the archival. Starfruit DNA® has another unique Electronic Case Folder that collects the comprehensive case-related information and compile with page numbers, time stamps and table of contents of the case reports to support the expert witnessing. Starfruit DNA® has been used by drug laboratories, genome laboratories, clinical trial laboratories and forensic laboratories.

DUII provides Starfruit DNA® maintenance and customization. DUII also provides the Information Technology services including software development, database design and management and computer network implementation.

DUII plans to amend the contract with DUII's new products. These will include the electronic signatures, smart card technology, Starfruit Forensic and related labor categories. Some of the new products are to add the compliant capability of FDA 21 CFR Part 11. Electronic Records; Electronic Signatures (http://www.fda.gov/ohrms/dockets/dockets/dockets.htm) to Starfruit DNA®

Headline: DUII Signed The Alliance Agreement with Celadon Laboratories, Inc.

Data Unlimited International, Inc. (DUII), Maryland, USA - 2/22/01 -
DUII established the alliance with Celadon Laboratories, Inc. (www.celadonlabs.com) to re-engineer, develop, integrate and market the bio-informatics software of both companies'. The mission is to combine the products and services of both companies to assist the bioscience industry in building the necessary regulatory computational infrastructure.

Celadon's patent-pending analytical software is pioneering bio-informatics solutions for the genetic diversity and gene expression segments of the Life Sciences industry. Its products include ProbeITy ^TM that is patent-pending software for picking optimal allele-specific hybridization probe and PCR primer sequences for genetic diversity assays and R.E.Search ^TM that is software for identifying restriction enzymes that discriminate among SNP alleles. Only 50% of SNPs are recognized by a known restriction enzyme. Because of this, Celadon's software identifies PCR primers to be used in site-directed mutagenesis so as to create an artifical restriction site polymorphism.

DUII will re-engineer these two software and integrate into DUII's Starfruit DNA® (http://www.duii.com/lims.htm), an improved Laboratory Information Management System (LIMS). The Inventory Control module of Starfruit DNA® tracks and monitor the chemicals, reagents, primers, instruments including the inventory thresholds, quality control data, distribution to the laboratories and personnel, the usage of the inventory and the association with the laboratory processes. It also documents the maintenance history of the instruments and the interface with the instruments. Integrating Celadon's ProbeITy and R.E. Search to Starfruit DNA® enables the laboratory scientists to design, select and order primers and restricted enzymes an online electronic activity that can be fully documented, reused, reviewed, and approved by the laboratory manager. Other benefits include the conformation to Food and Drug Administration (FDA) 21CFR11 (http://www.fda.gov/ohrms/dockets/dockets/dockets.htm) electronic records, electronic signature, cost mapping, vendor's performance and pricing statistics, tracing of the design of the primers and the restricted enzymes, etc.

More information can be found at www.duii.com.

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About Data Unlimited International, Inc. (DUII)
DUII is a private-held company with concentration in forensic, healthcare and bioinformatics. DUII develops and markets its products and services of laboratory information management system (LIMS), 21CFR11-aware computational infrastructure, and Standard Operating Procedure (SOP)-driven networks. These satisfy the requirements of 21CRF11 by authority check, operational system check, device check, SOP, electronic signature and closed systems. DUII creates tools to enhance communication and to enforce compliance.

©2001 Data Unlimited International, Inc. All rights reserved. Starfruit DNA and Starfruit Technologies are trademarks of Data Unlimited International, Inc.. registered in the U.S. and other countries. All other trademarks are the property of their respective owner. The mention of third party products and companies is for informational purposes only and does not constitute an endorsement or recommendation.