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JUNE 2001 INDUSTRY NEWS

Complying with 21 CFR Part 11, Electronic Records and Electronic Signatures

This document has been produced by a Special Interest Group of the GAMP Forum (pharmaceutical companies, suppliers, consultants and the Medicines Control Agency in the UK) in order to promote a better understanding of 21 CFR Part 11. It aims to provide industry and its suppliers with practical guidance on how to comply with the rule, while highlighting and addressing common issues of concern.

The manuscript provides a management process for achieving and maintaining compliance with 21 CFR Part 11 in manufacturing environments. Specific guidance is provided for both new and existing systems in addition to the role of suppliers in supporting this approach.

Appendices provide information, examples, templates, and checklists and a lifecycle for the management of electronic documents that are useful when implementing 21 CFR Part 11 compliance programs. A Glossary and References are also included.

This document is due for publication during the latter part of June 2001. Please refer to the GAMP organization's web site at www.gamp.org or www.ispe.org for ordering information when the document becomes available. The draft document will be available to members of the GAMP Forum (Europe and Americas) on the members area of the web site until the published document becomes available.

Tektronix Reports Record Results for the Fiscal Year

Tektronix, Inc. a leading developer of test, measurement, and monitoring equipment, reported record sales of $1.235 billion for fiscal year 2001. This is an 18% increase over sales of $1.051 billion for the measurement business in the prior year, generating net earnings, before non-recurring credits, of $1.38 per share -- more than a 60% increase over measurement business net earnings of $0.84 per share, excluding non-recurring charges, for fiscal 2000. Tektronix consolidated net earnings for fiscal 2000, including the gain on the sale of the Color Printer Division, and non-recurring items was $3.63 per share.

For the quarter, sales were $305.1 million and net earnings before non-recurring credits was $34.6 million, or $0.37 per share. This compares with sales of $298.7 million and net earnings, before non-recurring charges of $31.5 million or $0.32 per share for the measurement business in the same period a year ago.

For the first quarter of fiscal 2002, the company expects sales to decline 15 to 20% over the same period a year ago. Operating margins are expected to be in the mid-single digits. In addition, the company expects to incur one-time costs of approximately $10 million to align the cost structure with lower order and sales expectations.

Draft of joint ISO 9000 and ISO 14000 audit standard published

The draft of a new ISO (International Organization for Standardization) standard for auditing both ISO 9000 (quality) and ISO 14000 (environmental) management systems is now publicly available. Benefiting from the considerable body of experience that has built up on the auditing of ISO management systems, the standard will replace six existing ones in the ISO 9000 and ISO 14000 families. It will help user organizations to optimize their management systems, facilitate the integration of quality and environmental management, and, in allowing single audits of both systems, will save money and decrease disruption of work units being audited.

The draft International Standard ISO/DIS 19011, Guidelines for quality and/or environmental management systems auditing, can be purchased from ISO national member institutes, which are listed with full contact details on the ISO Web site (www.iso.ch), or from ISO Central Secretariat (sales@iso.ch). The French language version was expected to be published in July 2001. ISO/DIS 19011 was published on 31 May 2001 and has been distributed to ISO's members for a five-month ballot, closing on 31 October 2001. If approved, the document will subsequently be published, with modifications resulting from comments received, as a Final Draft International Standard for a further ballot. Its publication as a fully fledged International Standard is expected in 2002.

Both the ISO 9000 and ISO 14000 families of International Standards emphasize the importance of audits as a management tool for monitoring and verifying the effective implementation of an organization's policy for quality and/or environmental management. Audits are also an essential part of activities such as external certification/registration and of supply chain evaluation and surveillance. ISO 19011 provides guidance on the conduct of internal or external quality and/or environmental management system audits, as well as on the management of audit programs. Intended users of this International Standard include auditors, organizations implementing quality and/or environmental management systems, and organizations involved in auditor certification or training, certification/registration of management systems, and accreditation or standardization in the area of conformity assessment.

ISO 19011 will replace ISO 10011-1, ISO 10011-2 and ISO 10011-3 in the ISO 9000 family and ISO 14010, ISO 14011 and ISO 14012 in the ISO 14000 family. It will complete the ISO 9000 "core series" also comprising the revised ISO 9000, ISO 9001 and ISO 9004, published in December 2000.

For more information, contact: Roger Frost, Press and Communication Manager, Public Relations Services, ISO Central Secretariat, Tel 41 22 749 01 11 Fax 41 22 733 34 30 Email frost@iso.ch

A2LA provides purchasing information for a number of Measurement Uncertainty Guidance Documents.

The document titles include; U.S. Guide to the Expression of Uncertainty in Measurement, Guidelines for Evaluating and Expressing the Uncertainty of NIST Measurement Results, The Expression of Uncertainty and Confidence in Measurement, Expression of Uncertainty of Measurements in Calibration, Uncertainty and Dimensional Calibrations, The Expression of Uncertainty in Testing, and Quantifying Uncertainty in Analytical Measurement. Please visit the A2LA web site under the Laboratory Accreditation Requirements for the specific ordering information at www.a2la.org.

FARO Announces New Sales Director For North America

FARO Technologies Inc. announced the appointment of Robert Large to the position of Director of Sales for North America.

Large comes to FARO from Hill-Rom Company as Vice President of Sales, where he lead a 450-person sales team to $850M in revenue. Publicly held Hill-Rom is the world's leading manufacturer of patient care systems and the leading provider of specialized rental therapy products designed to assist in managing the complications of patient immobility. Large had been a Hill-Rom employee for nearly 15 years, also as Vice President of Corporate Accounts and Regional Director.

Standards Users Invited to Participate in IFAN Survey

June 1, 2001: The International Federation of Standards Users (IFAN), as a representative of standards users worldwide, has announced that it is conducting a survey on the use of international standards.

*NOTE: IFAN has confirmed that the contact information will be treated as confidential and will only be used if further clarification is needed.

The International Federation of Standards Users (IFAN), an independent, non profit-making international association of national organizations for the application of standards, companies, professional and trade associations, and governmental agencies, concerned with the use of standards, was founded in 1974 when eleven national standards organizations met in Paris for an International Conference.

The objectives of IFAN include the promotion of uniform implementation of standards without deviation and the development of solutions to standards users' problems without itself drawing up standards; the consolidation of standards users' interests and views on all aspects of standardization and conformity assessment, and to cooperate with international and regional standardizing bodies (e.g. ISO, IEC, ITU, CEN, COPANT, etc) in order to communicate user views to these organizations; and the promotion of networking in the field of international standardization and conformity assessment.

For links to further information go to www.ansi.org. To participate immediately in the survey go to www.nkn.nl/IFAN_quest.htm.

 

Grant Will Help Advance National Standards Strategy

The American National Standards Institute will use a recently awarded $500,000 annual grant from NIST to support international standardization and conformity assessment activities influencing international trade and regulations and to help advance the aims of a recently adopted U.S. National Standards Strategy.

In line with key objectives of the NSS, including work to "improve processes internationally to more closely reflect our [United States] principles and vision" and to "provide an outreach program to show those outside the United States the value of U.S. technology, standards and processes," ANSI says it will allocate NIST grant funds to initiatives such as outreach and education. Monies also will be used to identify opportunities to ensure that US technology, standards and standards-development processes receive fair consideration from other nations and regions.

Education initiatives will include training sessions for US participants in standards bodies such as the International Organization for Standardization and the International Electrotechnical Commission, and for representatives of developing nations that trade with the United States. ANSI also will provide training to acquaint other nations with the US standards and conformity assessment system. Another activity will help standards personnel in developing countries acquire the skills and knowledge necessary to host the secretariats (or administrative headquarters) of committees that develop standards for international use. The Western Hemisphere and Asia-Pacific region will be the primary focus of these efforts.

The NSS, which was developed by public and private-sector representatives of the standards community under ANSI's leadership, was approved on Aug. 31, 2000.

For more information, contact Walter Leight, NIST Office of Standards Services, (301) 975-4010, walter.leight@nist.gov. At ANSI, contact Stacy Leistner, (212) 642-4931, sleistne@ansi.org; or Joseph Tretler, (212) 642-4977, jtretler@ansi.org.

 
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