Electronic documents

Further discussion on electronic documentation systems can be found in the ISO 9000 Quality System Development Handbook hy David Hoyle (Butterworth-Heinemann, 1998). 

Rubenstein SD. Electronic documents in chemistry, from ChemDraw 1.0 to present. Abstracts of Papers, 228th ACS National Meeting, Philadelphia, PA, August 22-26, 2004. CINF-054. 

Another important aspect for discussion is the impact of regulations, spe-cihcally the regulation on electronic document management and electronic signatures, 21 CFR Part 11, published by the Food and Drug Administration (FDA) for the hrst time in 1997 [1] (also see Chapter 26, which covers 21 CFR Part 11 in detail). Since that time the draft rules of Part 11 have been withdrawn and reissued along with various guidance documents [2-3], Some of the key points of Part 11 are as follows ... 

Current computerized analyses of adverse events still typically consist of a vast number of discrete, often personal, ad hoc processes that mimic paper and pencil methods. Some commercial-off-the-shelf (COTS) software tools (e.g., Adobe Acrobat , Microsoft Word , Excel ) do have the capability to search for specihc terms in electronic documents/case reports and do have navigational tools with hyperlinks and fullfull-text indexing that enable researchers to create their own hyperlinks. Some other COTS software tools (e.g., SAS , Excel , Access , IMP ) allow importation of electronic case report tabulations (ECRT) for more detailed analysis. 

Also, electronic SOPs and protocols must be available to staff at all test sites for multisite studies. If the electronic documents are to be available at several sites, the validation phase of the system must include functionality testing at each site. Documentation of system validation needs to be available at each test site as well. Electronic SOPs must have a limited life span when printed to avoid the use of an outdated document. This may be achieved by stamping each SOP hard copy Printout not valid after date xx/xx/xx . This practice helps to ensure that system users will not retain printed SOPs long after the electronic SOP is revised. For company SOPs that are to be followed by an outside contractor who has no access to the electronic system, an alternative stamp may be used on the hard-copy SOPs that will be provided to the contractor that defines the date printed or indicates that the SOP is valid for use in a particular study. Whatever procedure is used, it must be clearly documented in an SOP. 

An organized document filing system must be maintained. This could be a paper file, an electronic document file, or a mixture of both. The equipment inventory system contains key information on the components of each system, their performance criteria and maintenance and calibration status. All documents including installation and performance documentation, as with other documents necessary to demonstrate the quality of the data, include SOPs for the qualification procedures, calibration, maintenance, personnel training, etc. If the manufacturer s operating, service, or maintenance manuals are used or cited in the operating procedures, copies of these manuals should be maintained. To facilitate retrieval, documentation should be stored in a central location and be indexed for easy retrieval. 

One of the primary differences between the FDA s and EPA s rules is the creation of the CDX. The EPA s OEI is currently developing the specifications for a CDX that will serve as the Agency s gateway for electronic documents received by the EPA. CROMERRR reports that with respect to the electronic document submission addressed by today s proposal, CDX functions will include the following ... 

The idea is to provide one way and one place for the regulated community to exchange electronic documents with EPA. The CDX may also provide the platform for State-EPA data exchanges. As with the provisions of the proposed rule, the features and functions of CDX described above will generally be inapplicable to these State-EPA exchanges. 

The EPA believes that these building blocks, taken together, do satisfy the criteria that today s proposal specifies for electronic document receiving systems. 

In 1990, the FDA published the electronic records and signatures rule as an initiative for the pharmaceutical industry. This allowed the use of electronic signatures in lieu of handwritten ones. This initiative opened the door to fully electronic documents. The rule became effective in August 1997 and addresses both electronic records and electronic signatures. 

This guidance document governs how electronic files should be sent to the FDA. Currently, the FDA requests that electronic documents be submitted as Portable Document Format (PDF) files. The PDF page should be a standard 8.5" x 11" page with 1" margins and 12-point font. Data sets are currently to be sent to the FDA as SAS XPORT transport format files. In the future it is likely that data sets will be required to be sent as XMF files, probably formatted in the CDISC ODM. 

Hardcopy SAS manuals (user s guides and reference) and electronic documentation have evolved over the years. In SAS 6 and earlier versions, SAS manuals were available only in hardcopy, and you had to use the SAS windowing environment for electronic help. With SAS 8, you can still get hardcopy manuals and you can use the SAS windowing environment to access help just as before. However, SAS also sells a CD-ROM called SAS OnlineDoc for SAS 8 that gives you the SAS manuals in HTML or PDF format. Finally, you can now get free SAS 8 documentation over the Internet in HTML format from SAS at http //support.sas.com/documentation/onlinedoc/index.html. 

Electronic diaphragm gauge, 20 658-659 Electronic digitizers, 14 614 Electronic document delivery, 13 249 Electronic effects... 

Despite it being the age of the computer, the first drafts of all chapters were written by hand so we owe an enormous debt of gratitude to our typist, Judith Kirby, Fellows Secretary at Merton College, Oxford. She miraculously transformed barely legible scribblings into immaculate electronic documents and then coped uncomplainingly with numerous further alterations. 

To cite an electronic document when there is no author provided, simply begin with the title. If there is more than one such document, alphabetize each piece according to its title. Similarly, if you have consulted a specific website or several websites, list them alphabetically, but be sure to include their precise and complete addresses. When writing your bibliography and/or footnotes, use the following format ... 

Advances in information technology are now impacting upon the pharmaceutical industry. Many documents are now maintained in electronic format. In fact, some regard it as likely that in the future paperless facilities will become commonplace, with all documentation being computerized. Several aspects of such electronic document maintenance deserve special attention. Adequate back-up files should always be retained. Also, restricted access to computerized systems is required to ensure that data/documentation is only entered/amended by persons authorized to do so. 

Records are retained for an appropriate length of time (generally 10 years or two generations over treatment duration) in machine-readable form. This is perhaps the most technologically controversial provision. While it is theoretically possible to retain machine-readable records (ASCII, e.g.—the alphanumeric code—is several decades old), the hkelihood that a formatted electronic document will be physically readable several years later is remote. Consider, for example, the 514-in. floppy disks of 10 years ago and the fact that new sizes of CDs are currently being introduced. 

Reports may be considered to be reviews. For electronic documents that provide an interpretation of data drawn from electronic records that are already subject to control, there is no clear need to reimpose these controls until the document is used for some official purpose. In a case of submissions, once a submission has been assembled and approved ready for submission to a regulatory agency it would then become an electronic record subject to audit trails. 

Another obvious reason why people hesitate to use electronically signed documents is a lack of assurance about how long the signed electronic documents can be stored and validated. 

Hardware is changing rapidly and many computer users can remember media they used to use and that are hardly readable today, like 8-inch floppy discs. The same is true for software. Formats of electronic documents are... 

Electronic signatures will be used for electronic documents with a limited validity until a good system of trusted electronic archives is built. 

Source of electronic documents Electronic source documents should be used for creation of PDF documents instead of scanned documents wherever possible. 

Digital certificates ensure private and secure submission of electronic documents. The digital certificate binds together the owner s name and a pair of electronic keys (a public key and a private key) that can be used to encrypt and sign documents. 

One or more of these options can be selected to submit electronic documents to the FDA. However, a separate registration will be required for each option selected. 

DIA Electronic Document Management Meeting, February 13, 2003 (Posted February 24,2003)... 

Electronic Submissions to the FDA, Randy Levin, MD, Fifth Annual Electronic Document Management Conference, September 23, 2002 (Posted November 14, 2002)... 

This guidance document is intended to provide instruction on how to submit a request for a meeting or teleconference in electronic format to ONADE at the CVM (or the Center). The guidance was revised to update the phone number for the Electronic Document Control Unit and to replace the Web site to submit electronic comments. 

If you do not receive an acknowledgment receipt from the CVM by the third business day after you have sent the submission, call the Electronic Document Control Unit at 301-827-8277 to report the problem and find out what happened to your submission. After review of the agenda and proposed dates, the CVM will contact the sponsor to finalize details of the meeting. 

ERSR Web page provides information on electronic drug applications, application reviews, Electronic Document Room, and other ERSR projects. 

---