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Signature Place

Users should be the prime participants in the preparation process so that the resultant documents reflect their needs and are fit for the intended purpose - hence the requirement that documents be reviewed as well as approved. You will need to be able to demonstrate that your documents have in fact been reviewed prior to issue. The presence of a signature on the front cover is not sufficient evidence. To demonstrate that documents have been reviewed you will need to show that nominated personnel have been issued with drafts for comment and that they have provided comments which have been considered by the approval authorities. A simple method is to employ a standard comment sheet on which reviewers can indicate their comments or signify that they have no comment. During the review process you may undertake several revisions. You may feel it necessary to retain these in case of dispute later, but there is no compulsion for you to do so, providing you have evidence that the review took place. You also need to show that the current issue has been reviewed so your comment sheet needs to indicate document issue status. [Pg.289]

There is no simple way of identifying invalid documents, as the reasons that they are invalid will vary. By printing authentic documents on colored paper or providing paper with a special header one can inject a degree of control. Placing the approval signatures on the front sheet will immediately identify an unapproved document. However, the onus must rest with the user who, if properly trained and motivated, will refrain from using invalid documents. [Pg.296]

Mix, it appears, wanted nothing less than a signature drink. When you ve got more stars than a movie, you don t rest on how many cosmopolitans you sell, I m guessing. The restaurant s bar, which employed Thierry Hernandez, and now Xavier Herit, from the Hotel Plaza Adienee in Paris, tried a truffle martini—truffle juice sprayed onto die glass in place of vermouth, with orange vodka. For an idea so potent, it was a nondescript drink. The truffles used were... [Pg.14]

Signature The form must be signed and dated. Ordinarily only one person should sign the form, i.e., the applicant, or the applicant s attorney, agent, or other authorized official. However, if the person signing the application does not reside or have a place of business within the United States, the application should be countersigned by an attorney, agent, or other authorized official who resides or maintains a place of business within the United States. [Pg.118]

GLP compliance for electronic records does not differ from GLP compliance for paper records. The increased access and distribution of records and documents enabled by electronic systems provide compliance challenges. There are many new questions to answer for example, what is the difference between electronic approvals and electronic signatures The solutions to these challenges lie in ensuring that system validation and management processes are in place, such as SOPs or procedures... [Pg.1028]

CFR - Part 11 means that you must be qualified to do your work, your programming must be validated, you must have system security in place, and you must have change control procedures for your SAS programming. The current additional FDA guidance on 21 CFR - Part 11 is titled Guidance for Industry Part 11, Electronic Records Electronic Signatures—Scope and Application. ... [Pg.6]

The label should be fairly obvious and so will need to be a significant size in relation to the item of equipment. For a small item such as a thermometer, a luggage label would be suitable. For a large instrument, a larger label would be appropriate, perhaps 15 x 10 cm. In each case, some means of fixing the label in place will be necessary. The label should reference any serial numbers which uniquely identify the instrument or its separate parts. The person under whose authority the label has been issued should be identified by signature or initial, and dated. The message should be brief and clear, e.g. OUT OF SERVICE - NOT TO BE USED UNTIL FURTHER NOTICE . [Pg.263]

An important benefit of the isotopic approach is that below-ground biomass values are not required. The 13C natural abundance isotopic carbon budget approach is based on C3 plants having lower 13C value than C4 plants (Ehleringer 1991 Clay et al. 2006) and that the signatures can be tracked by placing C3 plant residue into a soil derived from C4 plants or vice versa. In these calculations, several definitions are needed. These definitions include... [Pg.204]

The anticipated prorated payment, if any, to the participant for participating in the trial A statement of dosage/frequency and the probability for random assignment to each treatment An explanation of whom to contact for answers to pertinent questions about the research and research participants rights and whom to contact in the event of a research-related injury to the participant A statement that participation is voluntary, that refusal to participate will involve no penalty or loss of benefits to which the participant is otherwise entitled, and that the participant may discontinue participation at any time without penalty or loss of benefits to which the participant is otherwise entitled A place for signatures by the participant, physician, person obtaining consent, and witness (less signatures may be required) it depends on the policies and procedures of the particular IRB... [Pg.437]

The aromatic acids, as you would suspect from the name, have a benzene ring connected directly to the carboxyl signature group. Dicarboxylic acids have carbo l, groups attached in two places. Monocarboxylic adds have only one, and of course, the poly acids have three or more.. ... [Pg.256]


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Places

Placing

Signature

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