Modern-day business transactions are dynamic and involve multiple facets such as cross-border transactions, multiple parties situated in different continents, or the involvement of various currencies in one business transaction. Electronic signatures accelerate modern-day business transactions by facilitating a simpler and more efficient method of signing documents. Electronic signatures intend to present a safe and accurate description system for the signatory to affirm his signature. There are certain requirements to define a signature as a digital signature. These requirements are as follows:
Electronic signatures need to be unique to the individuals affirming the particular signature.
The method through which the signature is produced is possessed solely by the person making the signature.
This process can be utilized to identify the individual utilizing it.
When affixed to an electronic record, the electronic signature should identify whether any changes have been made to the record since the signing of the electronic signature.
Part 11 of the Code of Federal Regulations defines electronic records as any mixture of data, text, audio, graphics, pictorial, or different data descriptions as digital forms maintained, modified, archived, created, retrieved, or grouped through a computer. The reason behind giving such a comprehensive definition is to establish that electronic records are the same as paper records in the eyes of the law. Part 11 also elaborates on how to manage electronic records. The management of electronic records can be classified into the following components:
The organization maintaining the electronic record must have integrity and should manage the records which guarantee authenticity.
Organizations that come under the purview of the FDA Regulations must have a Records and Information Management department or an information governance program.
The organizations must maintain a clear records retention policy in tandem with the latest technologies. There should exist a specific retention period, and the organization must enforce it strictly.
Certain records classified as confidential, private, and privileged must be given certain protection. There should be a plan of backup or recovery in case the records get destroyed.
The U.S. Food and Drug Administration (FDA) has enacted rules for electronic record title 21 Part 11 of the Code of Federal Regulations since 1997. Several industries come under the ambit of FDA regulations. Industries such as pharmaceuticals, contract research or biotechnology organizations, and several other corporate outfits are governed by part 11 of the FDA regulations. These regulations elaborate on how electronic records and electronic signatures can be efficiently authenticated. The U.S. Congress passed the electronic signature in Global and National Commerce Act to promote electronic signature. It also promotes the various legal aspects associated with the signing of documents using an electronic signature. This act in section 106 defines electronic signature. The Federal Regulations perform an essential part in throwing light on the significance of electronic records. It defines electronic records and means of managing and regulating such records.
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