revised version of The Legal Acceptability Guide for Electronic Records for patent and regulatory litigation available for legal and regulatory communities...

rich at rich at
Fri Jun 7 20:17:22 EST 2002

We apologize for any duplications that may have occured on this or other
lists, but this landmark publication is getting very well received by the
entire patent community.  It outlines the key principles for legal
defensibility of electronic records.

Contact: Rich Lysakowski, CENSA
(781) 935-9600 or info at
Go to



   Fortune 50 firms, patent offices, regulatory agencies, and law firms
 partner to create a global standard for electronic records principles and
     practices to bolster intellectual property protection, regulatory
compliance, and general purpose legal and business recordkeeping in private
                            and public sectors.

Woburn, MA, June 8th, 2002 -- CENSA, the Collaborative Electronic Notebook
Systems Association, is pleased to announce an updated release of The Legal
Acceptability Guide for Electronic Records (LAGER).  Government agencies,
law firms and judges, records managers, archivists, information
technologists, and others grapple daily with the urgent paradigm shift from
paper to electronic records.  In organizations driven by research,
inventions, product development, competitive intelligence, or bureaucratic
needs, they must ensure that their records meet exacting regulatory,
patent, and quality requirements, while also meeting organizational
productivity and business needs.  This is a complex task with electronic
records because if programs or systems are designed improperly, electronic
records present inherently higher risks than paper or microfilm-based
records.   The LAGER provides the standard baseline for establishing
credible, reliable, and trustworthy Quality Electronic Records Programs for
creating and using electronic records for legal and regulatory purposes
across all private and public sector business environments.

The LAGER was developed by CENSA members from major R&D-driven business
enterprises, with strong participation from the leading government agencies
and archives on three continents.  The LAGER details requirements for
legal, patent, and regulatory compliance; quality assurance; information
technology; and records and archives management groups to follow in setting
up programs and systems.  Policy, procedures, and practices are identified
and specified, including policy compliance and enforcement, organizational
design and staffing requirements, and the proper treatment of new and
legacy systems.

"It is inefficient, expensive, and too often impossible to retrieve data
consigned to paper records," notes Rich Lysakowski, Ph.D., CENSA Executive
Director.  "The cost to society is increasing intellectual capital waste,
poor quality regulatory compliance, increasing legal liability, and a
widening gap in the digital record for the early 21st century.  Government
agencies, industry, and society at large cannot afford to pay that price
any longer.  This LAGER introduces the Standard Reference Model for Quality
Electronic Records Programs (QERPs), program responsibilities and roles,
and technical requirements for proper creation, maintenance, use, storage,
long-term preservation, and access of so-called "high-value" and
"high-consequence" records "born digital" whose integrity and authenticity
must remain intact in electronic form potentially permanently.  By tackling
more difficult types of high-consequence records, we have also solved the
problem for easier types of business records.  By simultaneously offering
short- and long-term solutions, the LAGER Guide enables effective
e-business and increased productivity now, as well as historical
recordkeeping, across public and private sector enterprises of all sizes."

The LAGER draws upon the expertise and best-of-breed knowledge of all of
its creators.  It was developed under the direction and with participation
from the US Patent and Trademark Office, Health and Human Services' FDA 21
CFR Part 11 and HCFA, the US National Archives, the US EPA, and Health
Canada.  It draws from quality practices established under the EPA's Good
Automated Laboratory Practices (GALPs), the National Archives of Australia,
the Canadian Government Public Key Infrastructure Standards and Rules,
national and international standards and practices like ISO 15489, BSI PD
0008:1999 and BSI EN ISO 9001, the DoD 5015.2 Records Management Standards,
and others.  Because of its broad coverage, this landmark standard makes it
possible for public and private sector organizations to understand and
implement electronic records programs based on current legal principles,
comprehensive and quality practices.

CENSA, the Collaborative Electronic Notebook Systems Association, is a
global market development association where the world's leading
corporations, technology providers, and government agencies work together
to develop automation solutions for complex scientific, technical and
business systems that support and drive rapid business process innovation.
CENSA's collaborative programs focus on improving the markets, products,
and standards for electronic records, electronic notebooks, business
process integration frameworks, knowledge management, and intellectual
capital asset utilization through more effective collaboration and
teamwork.  All CENSA members participate in practical, results-oriented,
team-based efforts to achieve these results.  The LAGER was developed under
the global Quality Electronic Records Practices Standards Program.

 For more information on CENSA, to directly order your copy of the LAGERS,
 please visit the CENSA website at, or contact CENSA
      directly at (781) 935-9600, or e-mail CENSA at info at

Rich Lysakowski, Ph.D.
Executive Director / Chief Science and Technology Officer
Collaborative Electronic Notebook Systems Association
800 West Cummings Park, Suite 5400
Woburn, Massachusetts  01801 USA
phone:   781-935-9600
fax:         781-935-3113
e-mail:    rich at


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