Electronic media

The principal use of CD-ROM and WORM disks is essentially substitution of data storage on paper or microfiche. Conservative estimates number the worldwide use for data storage by paper at 91%, microfiche at 4%, and in electronic media at 5%, of which 4% are magnetic and 1% optical media (18). CD-ROM is being used as an electronic counterpart to print media the WORM disk presents itself more and more as a substitute for paper to store archivable, forgery-proof documents. 

PTFE IS insoluble in all known solvents and resists attack by most chemicals, although its surtace is readily degraded by alkah metal-anunonia solutions. Such solvated electron media etch PTFE to produce a brown-black layer quite unlike the onginal white, low-friction, nonstick surface... 

Secure the scene get medical attention to tlie injured. Move bystanders aw ay to a safe distance. Inform print and electronic media. Protect people and property as necessary. Be aware tliat explosive materials and toxic vapors can do damage at a great distance... 

NUMBER OF VOLUMES SUBMITTED Please enter the number of volumes, including and identifying electronic media, contained in the archival copy of this submission. 

Please check the appropriate box to indicate whether this submission contains only paper, both paper and electronic media, or only electronic media. 

The archiving of electronic data poses more specific challenges. GLP requires records retention and retrieval of archival records. Since software used for the creation of electronic records is upgraded at a rapid pace, the requirement of retrievable archived records can be difficult to comply with. Even when stored on electronic media, the records have to comply with the records retention period and be retrievable. The collection, storage, and retrieval of electronic records should address all GLP aspects, including environmental conditions to ensure the integrity of the media. 

Sometimes, even in this electronic age , paper is still the medium of choice. For retained records that must be made available to personnel responding to an emergency, paper is a better medium than electronic media, because paper can remain accessible during emergency events (e.g., power outages, fires, floods, etc.) that could render electronic records inaccessible. 

This brings to mind another common problem. SOPs must be readily available in areas where GLP work is conducted. Protocols also must be accessible. Even when these documents exist only in electronic form, they must still be available, especially in the laboratory and study rooms. This means that computer systems that contain these documents must be available in the laboratory and study rooms and that all personnel who conduct work according to these SOPs must have access. The same is true for protocols and protocol changes. In cases where a merged system exists, i.e., both paper and electronic media are simultaneously in use, it is perfectly acceptable that only the electronic form is available in the laboratory areas while electronic or paper documents are available in offices. The only caveat is that a process must be in place to ensure the equivalency of the electronic and paper media. 

Another common problem is the failure to understand that, when using a merged system (some combination of paper and electronic records), both are the real SOPs, protocols, etc. As SOPs and protocols are transferred from paper to electronic media, frequently a signed, hard copy and an approved electronic version of the same document are maintained. Users of merged systems must remember that one must be able to demonstrate that the paper and electronic versions of an SOP, protocol, etc., are exactly the same. For example, if the SOP is signed on a certain date, the electronic version must also indicate that approval occurred on the same date. This means that a procedure (i.e., SOP) for ensuring document equivalency must be available and followed. 

Archived electronic data are to be treated no differently to archived paper data. An archivist should be assigned, access should be limited to authorized personnel, data should be archived at the completion of the study, and all material should be indexed to permit expedient retrieval. Depending on the medium used for storage, an area within the facility may be needed with specific environmental controls to maintain the integrity of electronic data. This should be specified in the data storage SOPs. Environmental conditions need to be monitored in the archives where electronic media are stored. 

A physical component of IT life cycle management is storage media management. Tapes, disks, and other electronic media degrade over time. Optimally, they are refreshed every 10 years. Ideally, this is part of the SOPs for the data centers and archive facilities. 

Since the last decade of the twentieth century to date, the IT industry assisted by internet and electronic media has changed the face of the world. Especially it has affected the Industry and Academia in the country. The students produced by the colleges and the Universities are unemployable due to lack of skill information the profitability of the industry has declined for the lack innovation and improvement in the technical backup and services. Exception being the IT industry. 

Documentation comprises procedures, instructions, test methods,batch records, and so on that are documented and controlled. Documentation is prepared, reviewed, and approved by qualified personnel. Approved copies of documents are distributed to relevant departments and superseded copies are retrieved and archived. The retention period for each type of document is specified. Documents are issued with document and version numbers for ease of identification and reference. Master copies of documents are filed at secured locations with authorized access. Master copies stored in electronic media require validation in accordance with FDA regulation 21 CFR Part 11 (see Section 9.6.3) to assess the security of access and data integrity. Operators are trained and retrained to only apply the latest approved documents. 

The search warrant must describe with particularity what is to be seized, when it is to be seized and location, so nothing is left to the discretion of the officer executing the warrant. This requirement limits the scope and duration of the search. Warrants are routinely issued for contraband, fruits and instrumentahties of crimes and evidentiary items such as, DNA, blood and urine samples, fingernail and skin scrapings, voice and handwriting exemplars, computer data, and electronic media. Information gained from valid warrantless searches may be used to obtain other warrants. 

Lovejoy, M. Post-Modern Currents The Age of Electronic Media. Englewood Cliffs Prentice-Hall, 1992. 

Once the process criteria have been identified various strategies can be followed to obtain the biocatalyst for the desired biotiansformation. Most commonly, first a literature, patent and electronic media search is performed ( database mining ) in order to find established biocatalysts that are known to catalyze the desired reaction or that catalyze a reaction that is similar to it (see 5.3.2). Databases that are becoming... 

Documents do not need to be delivered to the customer in paper format. Electronic media documents such as CDs are equally acceptable. Obviously, an appropriate reading system must be in place to access the documents at a later date (e.g., for an inspection). Such a system must remain in place until the... 

The vast increase in public awareness of the potential of chemicals to cause harmful effects and the propensity of the print and electronic media to fan the flames of controversy in this area make certain the continued need for toxicologists. We need to ask what they will be doing during the next few decades compared to what they have been doing in the immediate past. 

Large submissions should be packed in boxes measuring 14" x 12" x 9 j". All electronic media and any reviewer desk copies should be clearly marked and included in the first box of the shipment. The shipping containers should be identified with application number, product name, volume numbers, review copy or archival copy, and applicant name and address. Specific instructions for marking the mailing package (e.g., safety reports) should be followed. 

Acceptability of Electronic Submissions. In the Federal Register of March 20,1997 (62 FR13467), the Agency announced the establishment of a docket, number 92S-0251, where it will publish the submissions it will accept in electronic format. Once a Center has identified in the docket a submission type as one that can be processed, reviewed, and archived in an electronic-only format, you may provide the submission utilizing electronic media without any paper copies [21 CFR 11.1(d) and 11.2],... 

A description of the electronic submission including the type and number of electronic media used (e.g., two CD-ROMs), and the approximate size of the submission (e.g., 1.2 GB)... 

Several recent court cases have involved copyright infringement in electronic media. The legal disputes centered on which party controlled specific rights under the contractual arrangements authors had with publishers. A common thread to these cases is whether a publisher controls all rights to publish content... 

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