Signature, handwritten

Electronic signatures and handwritten signatures executed to electronic records shall be linked to their respective electronic records to ensure that the signatures cannot be excised, copied, or... 

Electronic signatures that are intended to be the equivalent of handwritten signatures, initials, and other general signings required. 

Electronic signatures are intended to be the equivalent of handwritten signatures, initials, and other general signings required by predicate rules. They include electronic signatures that are used, for example, to document the fact that certain events or actions occurred in accordance with the predicate rule (e.g., approved, reviewed, and verified). 

Electronic signature means a computer data compilation of any symbol or series of symbols executed, adopted, or authorized by an individual to be the legally binding equivalent of the individual s handwritten signature. 

The certification shall be submitted in paper form and signed with a traditional handwritten signature, to the Office of Regional Operations (HFC-100), 5600 Fishers Lane, Rockville, MD 20857. 

The link must be retained for as long as the record is kept, just as a handwritten signature stays with the paper, long after an employee has departed a company. Although a userid/password can be removed from a current user database, it must still be retained in an archive in order to maintain the signature and record linkage. 

The above hardware was used to create at NASK a multimodal biometric database BioBase, which at present contains images of iris, face, hand shape, and handwritten signatures, of couple of hundred volunteers. BioBase will be employed here to test the proposed approaches. 

Whether or not the site has certified to FDA that it intends all electronic signatures to be equivalent to traditional handwritten signatures... 

A paper copy that includes the handwritten signature of the sponsor authorized representative and the IND number to identify the electronic document and attachments. 

The identification of inks in handwritten signatures can be important in the field of questioned documents. Since ink formulations are periodically changed by manufacturers, it is at times possible to date the handwritten signature. Current practice involves punching out a small spot of the signature, followed by extraction and thin layer chromatographic (TLC) development (5). Use of modern LC can lead to better resolution, more sensitive detection, and where necessary, better quantitation than TLC. We have developed a simple gradient system for the separa-... 

Systems such as Manufacturing Execution Systems (MES) or Electronic Batch Record Systems (EBRS) that rely upon electronic identification of individuals should ensure that electronic identification/signatures are secure from abuse and falsification and that substitutes for handwritten signatures should nonetheless be as secure as conventional handwritten signatures. ... 

Electronic and digital signatures are addressed in Europe in a directive that describes what is considered a suitable substitute for traditional handwritten signatures. The directive is not specific for the pharmaceutical industry, but was intended mainly to regulate electronic commerce between companies and the correspondence between industry and authorities or between authorities. Therefore not all concepts and requirements presented apply in the same manner to the signatures used within a company for internal documentation where other security mechanisms as to the identity and accountability of employees exist. 

Purpose Legally binding equivalent to Computer-generated logfile handwritten signature ... 

---