Newly Published Pfizer White Paper Chronicles Adaptation of SAFE™ Digital Signatures for Company’s Electronic Laboratory Notebooks
FT. LEE, N.J.–(BUSINESS WIRE)–A newly published Pfizer white paper, “Pfizer Implementation of SAFE™ Digital Signatures for Electronic Lab Notebooks,” describes how the company successfully introduced digitally-signed electronic notebooks to its Global Research and Development organization. The document can be downloaded at www.safe-biopharma.org.
The 19-page document chronicles the introduction, development and adaptation of digitally signed Chemistry electronic Notebooks (CeN) which have more than 2200 users within Pfizer and average more than 1000 signatures per day. The CeNs are signed and witnessed using SAFE™ digital signatures.
Historically, laboratory notebooks have been paper-bound books used to document daily experiments and dated, signed and witnessed on a daily basis. Among other uses, records in laboratory notebooks are used to defend drug patents. In recent years, the notebooks have become electronic, resulting in a reduction of paper, savings in records management, easier access to stored information, and generally, less record-keeping time for scientists.
“Pfizer developed this white paper to share with the rest of the industry. Our experience introducing electronic laboratory notebooks and SAFE digital signature technology. This is consistent with Pfizer’s role as a leader in the development of the SAFE technology within the pharmaceutical industry,” said George Rathbun, Director, Pfizer Regulatory Compliance and a member of the Board of Directors of SAFE-BioPharma Association.
As the Pfizer white paper explains, key to use of its Chemistry electronic Notebooks is use of the SAFE digital signature, a technology standard that allows its scientists to apply an easily used time-stamped electronic signature. The SAFE digital signature 1) is legally equivalent to a “wet” or ink-based signature; 2) meets or exceeds regulatory guidelines for 21 CFR Part 11 and HIPPA in the USA, as well as meeting similar international guidelines; 3) ensures security and data integrity, and 4) is designed for global use.
The Pfizer white paper has an Executive Summary followed by individual chapters describing research and business issues associated with introducing CeN and use of SAFE digital signatures, communicating to different levels of the organization and training those who would be using the technology. The white paper also describes the numerous business benefits Pfizer has experienced through use of CeN and SAFE signatures. These include the ability to produce records without needing to produce the accompanying paper, the ability to search and find specific records, legibility of signatures, and the ability to associate a signature with the individual who signed the document, both now and into the future.
The paper also includes sections in which Pfizer executives give advice about introducing SAFE digital signatures within the organization.
In addition to the Pfizer white paper, other new educational materials about the SAFE digital identity and signature standard available at www.safe-biopharma.org, include a five-minute video presenting case studies from AstraZeneca and Procter & Gamble, as well as legal considerations concerning SAFE digital signatures, and the SAFE Implementation Toolkit, an on-line repository of templates, reports and analytical documents that reflects the collective experience of companies involved in the development and use of the SAFE standard. Much of the Toolkit’s content comprises internal documents contributed by the industry’s largest companies.
About Pfizer
Pfizer, Inc., founded in 1849, is dedicated to better health and greater access to healthcare for people and their valued animals. Our purpose is helping people live longer, healthier, happier lives. Our route to that purpose is through discovering and developing breakthrough medicines; providing information on prevention, wellness, and treatment; consistent high-quality manufacturing of medicines, consumer products; and global leadership in corporate responsibility. Every day we help 38 million patients, employ more than 100,000 colleagues, utilize the skills of more than 12,000 medical researchers, and work in partnership with governments, individuals, and other payers for healthcare to treat and prevent illnesses – adding both years to life and life to years.
About SAFE-BioPharma Association
SAFE-BioPharma Association is the non-profit association that created and manages the SAFE™ digital identity and digital signature standard for the pharmaceutical and healthcare industries. Through the SAFE standard, the association promotes interoperability and integration among researchers, vendors, regulators, clinicians and other pharmaceutical and healthcare stakeholders. The SAFE standard provides a secure, enforceable, and regulatory compliant way to verify the identities of parties involved in business-to-business and business-to-regulator electronic transactions. SAFE stands for “Signatures and Authentication For Everyone.” The Association’s founder-members include AstraZeneca, Bristol-Myers Squibb, GlaxoSmithKline, Johnson & Johnson, Merck, Pfizer, Procter & Gamble, and Sanofi-Aventis. For more information visit www.safe-biopharma.org.
SAFE™ is a trademark of SAFE-BioPharma Association. Any use of this trademark requires approval from SAFE-BioPharma Association.
