Borland Helps to Streamline Information Flow Within Regulated Organizations.Business Editors/High-Tech Writers SCOTTS VALLEY, Calif.--(BUSINESS WIRE)--Dec. 18, 2003 Addition of Electronic Signature Capabilities to Borland(R) CaliberRM(TM) and Borland(R) StarTeam(R) Designed to Ease Auditing Process Borland Software Corporation (company) Borland Software Corporation - A company that sells a variety of PC software development and database systems. Borland was founded in 1983 and initially became famous for their low-cost software, particularly Turbo Pascal, Turbo C, and Turbo Prolog. (Nasdaq:BORL) has announced support for electronic signatures within Borland(R) CaliberRM(TM), a leading requirements definition and management system and Borland(R) StarTeam(R), an automated configuration and change management system; key components of the Borland Application Lifecycle Management The administration and control of an application from inception to its demise. It embraces requirements management, system design, software development and configuration management and implies an integrated set of tools for developing and controlling the project. (ALM) strategy for software development. In light of increased industry regulation, electronic signatures are especially important for organizations such as those governed by the United States Food and Drug Administration United States Food and Drug Administration (FDA), n.pr a unit of the Public Health Service created to protect the health of the nation against impure and unsafe foods, drugs, and cosmetics. (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ). Electronic signature capabilities such as those offered by CaliberRM and StarTeam eliminate the need to update and maintain paper records, allowing organizations to maintain a complete digital history of project requirements, changes and approvals. This replaces the traditional practice of manually updating and maintaining paper records. "Achieving agile software management processes in regulated industries presents problems unless paper trials are minimized," said Jim Duggan James Stuart Duggan (born January 14, 1953), better known by his ring name "Hacksaw" Jim Duggan, is an American professional wrestler, currently signed to World Wrestling Entertainment wrestling on its RAW brand. of Gartner. "Being able to adopt electronic signatures will be attractive to those with significant audit requirements." "We are helping enterprises to keep up with regulation requirements by streamlining the flow of information within their organizations, so that errors caused by lost or improperly filed documents are minimized. By enabling the use of electronic signatures in place of full handwritten hand·write tr.v. hand·wrote , hand·writ·ten , hand·writ·ing, hand·writes To write by hand. [Back-formation from handwritten.] Adj. 1. signatures, time consuming manual processes may be automated," explained Patrick Kerpan, vice president and general manager of DSP (1) (Digital Signal Processor) A special-purpose CPU used for digital signal processing applications (see definition #2 below). It provides ultra-fast instruction sequences, such as shift and add, and multiply and add, which are commonly used in math-intensive solutions at Borland. "Electronic signatures can be easily validated, tracked throughout the approval process, and archived for future reference." Borland Integrated ALM The Borland application lifecycle management (ALM) strategy is designed to help organizations align business requirements and software capabilities for greater competitive advantage. As key components of the Borland ALM solution, CaliberRM and StarTeam provide definition and change management capabilities, which help to set and manage expectations within the development team, as well as assisting in the control of volatile requirements and change management processes throughout the application lifecycle. Meridian Technique, a provider of orthopaedic digital imaging software across the globe, is one life sciences organization using the Borland ALM solution to automate time-consuming and error-prone manual programming processes such as the hand-merging of files. The ability to accurately track requirements from conception to validation is designed to enable Meridian Technique to more easily prove compliance with ISO (1) See ISO speed. (2) (International Organization for Standardization, Geneva, Switzerland, www.iso.ch) An organization that sets international standards, founded in 1946. The U.S. member body is ANSI. 9000 and other regulatory obligations such as the United States Food and Drug Administration (FDA) 510(K). "The medical software market is intensely competitive and highly regulated. Therefore, to stay one step ahead, it's essential that we are able to develop reliable software, cost-effectively and in the fastest time possible. On all counts, we are confident that the Borland ALM solution will deliver this competitive edge," said Dave Kitson David Barry Kitson (born 21 January 1980, Hitchin, England) is an English footballer, currently playing for Reading in the Premier League. Club career One of the most exciting and talented players that has played for Cambridge United and Arlesey Town near the bottom of , technical director at Meridian Technique. Electronic Signature Capabilities FDA regulated companies must demonstrate compliance with rules regarding electronic records and signatures as defined in 21 CFR CFR See: Cost and Freight Part 11(a). This Federal code is designed to allow the FDA to safeguard public health while providing regulated companies in the pharmaceutical, medical device, biological and food industries with the ability to create efficient, paperless record-keeping and signing practices. CaliberRM and StarTeam now include new capabilities designed to allow FDA-governed organizations, or frequently audited companies, to adopt electronic signatures with confidence in the data captured. Both solutions provide individual users with user identification and pass codes, attaching a name and time/date stamp to each user's log in. Because signatures are specifically linked to their respective electronic records, unauthorized copying or falsification falsification /fal·si·fi·ca·tion/ (fawl?si-fi-ka´shun) lying. retrospective falsification unconscious distortion of past experiences to conform to present emotional needs. is restricted. In addition, illegal attempts to use signatures are automatically reported, with administrators able to configure both CaliberRM and StarTeam to disable accounts after a certain number of failed login attempts. Availability Borland CaliberRM and Borland StarTeam are available now from authorized resellers. For more detailed product information on CaliberRM, visit: http://www.borland.com/caliber/index.html. For information on StarTeam, visit: http://www.borland.com/starteam/index.html. Note to Editors (a) Additional information on Title 21 Code of Federal Regulations The New Deal program of legislation enacted during the administration of President franklin roosevelt established a large number of new federal agencies, which generated a shapeless and confusing mass of new regulations. (21 CFR Part 11) Electronic Records; Electronic Signatures can be obtained from the Federal Office of Regulatory Affairs The Office of Regulatory Affairs (ORA) is the part of the United States FDA that enforces the laws that govern food, drugs, medical devices, and other products that FDA regulates. : http://www.fda.gov/ora/compliance_ref/part11/. About Borland Borland Software Corporation (Nasdaq:BORL) is a world leader in platform independent software development and deployment solutions that are designed to accelerate the entire application development lifecycle. By connecting managers, testers, designers, developers, and implementers in real time, Borland enables enterprises worldwide to define and sustain their competitive advantage. For more information, visit: http://www.borland.com/ or the Borland Developer Network at http://bdn.borland.com/. All Borland brand and product names are trademarks or registered trademarks of Borland Software Corporation in the United States and other countries. All other marks are the property of their respective owners. Safe Harbor Safe Harbor 1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated. 2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive. Statement This release contains "forward-looking statements" as defined under the Federal Securities Laws, including the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995 and is subject to the safe harbors created by such laws. Forward-looking statements may relate to, but are not limited to, the demand for StarTeam and CaliberRM products, or benefits to be derived from StarTeam and CaliberRM and market and technological trends in the software industry. Such forward-looking statements are based on current expectations that involve a number of uncertainties and risks that may cause actual events or results to differ materially. Factors that could cause actual events or results to differ materially include, among others, the following: the potential effects on Borland of competition with StarTeam and CaliberRM, growth rates Growth Rates The compounded annualized rate of growth of a company's revenues, earnings, dividends, or other figures. Notes: Remember, historically high growth rates don't always mean a high rate of growth looking into the future. in the software and professional services markets that Borland participates in, rapid technological change that can adversely affect the demand for StarTeam and CaliberRM, delays in scheduled product availability dates, actions or announcements by competitors and software errors. These and other risks may be detailed from time to time in Borland periodic reports filed with the Securities and Exchange Commission, including, but not limited to, its latest Annual Report on Form 10-K Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 10-K. and its latest Quarterly Report on Form 10-Q Form 10-Q See 10-Q. , copies of which may be obtained from http://www.sec.gov/. Borland is under no obligation to (and expressly disclaims any such obligation to) update or alter its forward-looking statements whether as a result of new information, future events or otherwise. |
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