解读新版 Softmax Pro 7.2 GXP 软件之双重身份验证

①  Softmax Pro 7.2 GXP 符合 21 CFR Part 11 法规

§11.200 – Electronic Signature components and controls

(a) Electronic signatures that are not based upon biometrics shall:

(1) Employ at least two distinct identification components such as an identification code and password.

(i) When an individual executes a series of signings during a single, continuous period of controlled system access, the first signing shall be executed using all electronic signature components; subsequent signings shall be executed using at least one electronic signature component that is only executable by, and designed to be used only by, the individual.

(ii) When an individual executes one or more signings not performed during a single, continuous period of controlled system access, each signing shall be executed using all of the electronic signature components.

②  Softmax Pro 7.2 GXP 符合欧盟法规

12. Security

12.1 Physical and/or logical controls should be in place to restrict access to computerized system to authorized persons. Suitable methods of preventing unauthorized entry to the system may include the use of keys, pass cards, personal codes with passwords, biometrics, restricted access to computer equipment and data storage areas.

12.3 Creation, change, and cancellation of access authorizations should be recorded.

12.4 Management systems for data and for documents should be designed to record the identity of operators entering, changing, confirming or deleting data including date and time.

14. Electronic Signature

Electronic records may be signed electronically. Electronic signatures are expected to:

a. have the same impact as hand-written signatures within the boundaries of the company.

b. be permanently linked to their respective record.

c. include the time and date that they were applied.

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