Businesses are deploying Public Key Infrastructures (PKIs) to support internal business processes, implement virtual private networks, and secure corporate assets. The ability to establish business relations inside the company as well as wirh other companies in a secure way is important for the operability of business in today's world; corporate PKIs may implement different architectures, security policies, and cryptographic suites in order to accomplish this goal, But communication beyond the PKI is established with other companies based on a trust relationship (B2B), which brings vulnerability provided by PKIs from different companies. A flexible mechanism is needed to link these corporate PKIs and translate corporate relationships with security mechanisms and policies. This is accomplished through a Password Authentication Protocol (PAK), which provides means to authenticate or validate users across Bridge Certijication Authorities (BCA), where certijicates authorities (CA) are limited and mnnot reach over to the other side of the BCA. In such way PAK, can guarantee authentication of end pointswithout modifiing the original PKI structure of companies and offer flexibility in the process of implementation. Additional to this, there are seveml other issues that must be solved; such as the ability to connect different company PIU without compromising any sensible information that might cause a conflict of commercial interests and still guarantee a certain level of security through an accreditation and validation of the parties in order to be certain with who we are doing business. In order to achieve accreditation and validation of PKIs and not expose any sensible information that could compromise either parties, we also based our work on a Zero Knowledge security protocol letting each PKI continue with their security policies without having to a@st to specific needs, achieving a better security level of commercial transactions through such hardening process
The documentation system is one of the mandatory elements reviewed during inspections of any regulatory agency. Generally, 20 to 30 percent of the deviations detected in a pharmaceutical inspection, are directly related to the documentation of quality system in each of the components or systems inspected. Given that no regulation on GMP will tell us in detail how the documentation system should be, we aimed to show in this work an approach used to implement some of the quality tools for establishment and maintenance of GMP and inherent Documentation in order to comply with the normative, national and international regulations typical of a productive process monoclonal antibody (MAb) which is secreted by the hybridoma 48/1/5/4, specific for the "a" determinant of the Hepatitis B surface antigen (HBsAg). This MAb is routinely used as reagents for the purification of vaccines.
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