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- Electronic Records. (Books and References).
- Kluwer International New York has published Preservation of the Integrity of Electronic Records, a hardbound book that addresses issues relating to reliability and authenticity of electronic records. Designed for professionals involved in the creat Kluwer International New York has published Preservation of the Integrity of...
- Research articles 2002-09-30
- AXS-One Announces Integration With IBM System Storage DR550, Offering Highly Efficient Archival and Retrieval With Price Performance
- AXS-One Inc. (AMEX: AXO), a leading provider of high performance records compliance management solutions RCM, today announced that the AXS-One Compliance PlatformTM, the single, scalable archiving and electronic records management software platform for policy-based management of disparate electronic records, will fully support the IBM System Storage DR550 and IBM System...
- Research articles 2007-01-22
- FDA withdraws pharmaceutical guidelines on electronic records
- On February 20, the U.S. Food & Drug Administration (FDA; Rockville MD; www.fda.gov) shocked the pharmaceutical industry and withdrew its guidelines for enforcing 21 CFR, Part 11, the law governing the use of electronic records and signatures in pharmaceutical manufacturing.
- Research articles 2003-05-01
- 21 CFR Part 11 and systems assessment: key to complying with the FDA's electronic record-keeping regulation and reaping the associated benefits is understanding regulation requirements and the software to support compliant operations.(INSIDE PHARMA)
- By establishing the criteria under which electronic records and electronic signatures are considered equivalent to paper records and handwritten signatures executed on paper, 21 CFR Part 11 has given the pharmaceutical industry a universally accept By establishing the criteria under which electronic records and...
- Research articles 2005-04-01
- Baan PRISM Enterprise Software Validated For US FDA Signatures and Electronic Records Rules of 21 CFR Part 11
- Business Editors
- Research articles 2002-08-19
- Open Text Introduces Records Management 2.0, Adding Features to Manage Physical Records With Electronic Records in Livelink
- Business Editors/High-Tech Writers
- Research articles 2002-06-18
- 'I'm from the government, and I'm here to help you!'.
- As scary as that sounds, governments' regulations about electronic records and signatures hold the potential to produce measurable business benefits. However, it requires a corporate-wide strategy and executive-level commitment. Otherwise complianc As scary as that sounds, governments' regulations about electronic records and signatures...
- Research articles 2002-04-01
- ``FDA Electronic Records, Submissions & Signatures — 1999'' Released
- COSTA MESA, Calif.--BW HealthWire--July 9, 1999--
- Research articles 1999-07-09
- CSC announces creation of task force to help pharmaceutical companies deploy electronic records
- WALTHAM, Mass.--BUSINESS WIRE--May 27, 1997--
- Research articles 1997-05-27
- Electronic record regs create big paper burden
- Drug companies have told the FDA that its regulations on electronic records and signatures will create a massive, expensive paperwork burden, rather than reducing the burden as the agency had projected. In comments to the FDA, Pharmaceutical Research and Manufacturers of America, Eli Lilly, and Bristol-Myers Squibb all said they...
- Research articles 2000-02-01
- Misys Healthcare Systems Cheers David Brailer and the National Spotlight on Accelerated Electronic Record Adoption at TEPR 2004
- Business Editors/Health/Medical Writers
- Research articles 2004-05-20
- ``FDA Electronic Records, Submissions & Signatures — 1999''; Important Regulatory Guidance Manual Released; Newly Expanded/Updated
- COSTA MESA, Calif.--BW HealthWire--Aug. 17, 1999--
- Research articles 1999-08-17
- Lear project shows expense of e-records.(News)(Lear Corp)
- Byline: Ralph Kisiel Automotive News Lear Corp. is almost done with a two-year project to archive its growing mountain of electronic records, but it has been far more than just housekeeping. Although electronic-records management sounds mundane, Byline: Ralph Kisiel Automotive News...
- Research articles 2006-05-15
- Change in FDA stance on Part 11 requirements. (regulation and standards column).(electronic records and signatures)
- The United States Food and Drug Administration FDA has decided to reexamine its regulations for electronic records and signatures, and during this process, to reduce the enforcement of some of the provisions of the regulations. This article discu The United States Food and Drug...
- Research articles 2003-04-01
- eManage delivers Electronic Record Management Solution for Microsoft SharePoint Portal Server.
- ORLANDO, FLORIDA, OCTOBER 5, 2001 ORLANDO, FLORIDA, OCTOBER 5, 2001
- Research articles 2001-10-05
- eManage delivers Electronic Record Management Solution for Microsoft SharePoint Portal Server
- Business & High-Tech Editors
- Research articles 2001-10-05
- Travis County Makes Public Documents Safer, More Accessible Using Hart InterCivic's Electronic Record Management System; Wills, Other Probate Documents Now Available Online
- Business Editors/Political/High-Tech Writers
- Research articles 2003-02-18
- FDA takes risk-based stance on Part 11 rule.(Regulations And Systems)
- Manufacturers in highly regulated industries have gained a little breathing room from the U.S. Food and Drug Administration FDA on the 21 CFR Part 11 rule, which governs electronic recordkeeping. The regulations require makers of regulated p Manufacturers in...
- Research articles 2003-12-01
- Misys Healthcare Systems Broadens Electronic Records Adoption with 27 More Practices Selecting Misys EMR
- Business Editors/Health/Medical Writers/High-Tech Writers
- Research articles 2004-06-02
- FileTek Participates on Lockheed Martin Team to Provide Archival Storage Expertise for U.S. National Archives $308 Million Electronic Records Archive Project
- ROCKVILLE, Md. -- FileTek Data Management Capabilities Ensure the Reliability, Longevity, Scalability, Recoverability, and Integrity of Large, Long-Term Digital Archives
- Research articles 2005-10-11
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