法规：Part 11.10 a

法规描述：Validation of systems to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records

法规：Part 11.10 b

法规描述：The ability to generate accurate and complete copies of records in both human readable and electronic form suitable for inspection, review, and copying by the agency

法规：Part 11.10 c

法规描述：Protection of records to enable their accurate and ready retrieval throughout the records retention period

法规：Part 11.10 d

法规描述：Limiting system access to authorized individuals.

法规：Part 11.10 e

法规描述：Use of secure, computer-generated, time-stamped audit trails to independently record the date and time of operator entries and actions that create, modify, or delete electronic records

法规：Part 11.10 f

法规描述：Use of operational system checks to enforce permitted sequencing of steps and events, as appropriate

法规：Part 11.10 g

法规描述：Use of authority checks to ensure that only authorized individuals can use the system, electronically sign a record, access the operation or computer system input or output device, alter a record, or perform the operation at hand

法规：Part 11.10 h

法规描述：Use of device (e.g., terminal) checks to determine, as appropriate,the validity of the source of data input or operational instruction

法规：Part 11.10 i

法规描述：Determination that persons who develop, maintain，or use electronic record/electronic signature systems have the education,training,and experience to perform their assigned tasks

法规：Part 11.10 j

法规描述：The establishment of, and adherence to, written policies that hold individuals accountable and responsible for actions initiated under their electronic siqnatures, in order to deter record and signature falsification

法规：Part 11.10 k1

法规描述：Adequate controls over the distribution of access to, and use of documentation for system operation and maintenance

法规：Part 11.10 k2

法规描述：Revision and change control procedures to maintain an audit trail that documents time-sequenced development and modification of systems documentation

法规：Part 11.50 a1

法规描述：Signed electronic records shall contain the printed name of the signer

法规：Part 11.50 a2

法规描述：Signed electronic records shall contain the date and time when the signature was executed

法规：Part 11.50 a3

法规描述：Signed electronic records shall contain the meaning (such as review, approval, responsibility, or authorship) associated with the signature

法规：Part 11.50 b

The items identified in requirements 11.50 a1, 11.50 a2 and 11.50 a3 of this section shall be subject to the same controls as for electronic records and shall be included as part of any human readable form of the electronic record (such as electronic display or printout

法规：Part 11.70

法规描述：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 otherwise transferred to falsify an electronic record by ordinary means

法规：Part 11.100 a

法规描述：Each electronic signature shall be unique to one individual andshall not be reused by, or reassigned to, anyone else

法规：Part 11.200 a1

法规描述：Electronic signatures shall employ at least two distinct identification components such as an identification code and password

法规：Part 11.200 a1i

法规描述：When an individual executes a series of signings during a single, continuous period of controlled system access, the first signing or login event 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

法规：Part 11.200 alii

法规描述：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

法规：Part 11.200 a2

法规描述：Electronic signatures are to be used only by their genuine owners

法规：Part 11.200 a3

法规描述：Electronic signatures are to be administered and executed to ensure that attempted use of an individual’s electronic signature by anyone other than its genuine owner requires collaboration of two or more individuals

法规：Part 11.200 b

法规描述：Electronic signatures based upon biometrics shall be designed to ensure that they cannot be used by anyone other than their genuine owners

法规：Part 11.300 a

法规描述：Maintaining the uniqueness of each combined identification code and password, such that no two individuals have the same combination ofidentification code and password

法规：Part 11.300 b

法规描述：Ensuring that identification code and password issuances are periodically checked, recalled,or revised (e.g.,to cover such events as password aging)

法规：Part 11.300 c

法规描述：Following loss management procedures to electronically de-authorize lost stolen, missing, or otherwise potentially compromised tokens,cards,and other devices that bear or generate identification code or password information, and to issue temporary or permanent replacements using suitable, rigorous controls

法规：Part 11.300 d

法规描述：Use of transaction safeguards to prevent unauthorized use of passwords and/or identification codes, and to detect and report in an immediate and urgent manner any attempts at their unauthorized use to the system security unit, and, as appropriate, to organizational management

法规：Part 11.300 e

法规描述：lnitial and periodic testing of devices, such as tokens or cards, that bear or generate identification code or password information to ensure that they function properly and have not been altered in an unauthorized manner