GxP (Good Practices) 21 CFR Part 11

gxp_21_cfr_part_11_aws

GxP-21-CFR-Part-11

OfficialVerified

GxP refers to the regulations and guidelines that are applicable to life sciences organizations that make food and medical products. Medical products that fall under this include medicines, medical devices, and medical software applications. The overall intent of GxP requirements is to ensure that food and medical products are safe for consumers. It's also to ensure the integrity of data that's used to make product-related safety decisions.

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Requirements (11)

11.10 Controls for closed systems7133

11.10-aPersons who use closed systems to create, modify, maintain, or transmit electronic records shall employ procedures and controls designed to ensure the authenticity, integrity, and, when appropriate, the confidentiality of electronic records, and to ensure that the signer cannot readily repudiate the signed record as not genuine. Such procedures and controls shall include the following: (a) Validation of systems to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records.11

Attributes

Item Id: 11.10-a
Section: 11.10 Controls for closed systems
Service: aws

11.10-cPersons who use closed systems to create, modify, maintain, or transmit electronic records shall employ procedures and controls designed to ensure the authenticity, integrity, and, when appropriate, the confidentiality of electronic records, and to ensure that the signer cannot readily repudiate the signed record as not genuine. Such procedures and controls shall include the following: (c) Protection of records to enable their accurate and ready retrieval throughout the records retention period.13

Attributes

Item Id: 11.10-c
Section: 11.10 Controls for closed systems
Service: aws

11.10-dPersons who use closed systems to create, modify, maintain, or transmit electronic records shall employ procedures and controls designed to ensure the authenticity, integrity, and, when appropriate, the confidentiality of electronic records, and to ensure that the signer cannot readily repudiate the signed record as not genuine. Such procedures and controls shall include the following: (d) Limiting system access to authorized individuals.36

Attributes

Item Id: 11.10-d
Section: 11.10 Controls for closed systems
Service: aws

11.10-ePersons who use closed systems to create, modify, maintain, or transmit electronic records shall employ procedures and controls designed to ensure the authenticity, integrity, and, when appropriate, the confidentiality of electronic records, and to ensure that the signer cannot readily repudiate the signed record as not genuine. Such procedures and controls shall include the following: (e) 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. Record changes shall not obscure previously recorded information. Such audit trail documentation shall be retained for a period at least as long as that required for the subject electronic records and shall be available for agency review and copying.13

Attributes

Item Id: 11.10-d
Section: 11.10 Controls for closed systems
Service: aws

11.10-gPersons who use closed systems to create, modify, maintain, or transmit electronic records shall employ procedures and controls designed to ensure the authenticity, integrity, and, when appropriate, the confidentiality of electronic records, and to ensure that the signer cannot readily repudiate the signed record as not genuine. Such procedures and controls shall include the following: (g) 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.42

Attributes

Item Id: 11.10-g
Section: 11.10 Controls for closed systems
Service: aws

11.10-hPersons who use closed systems to create, modify, maintain, or transmit electronic records shall employ procedures and controls designed to ensure the authenticity, integrity, and, when appropriate, the confidentiality of electronic records, and to ensure that the signer cannot readily repudiate the signed record as not genuine. Such procedures and controls shall include the following: (h) Use of device (e.g., terminal) checks to determine, as appropriate, the validity of the source of data input or operational instruction.2

Attributes

Item Id: 11.10-h
Section: 11.10 Controls for closed systems
Service: aws

11.10-kPersons who use closed systems to create, modify, maintain, or transmit electronic records shall employ procedures and controls designed to ensure the authenticity, integrity, and, when appropriate, the confidentiality of electronic records, and to ensure that the signer cannot readily repudiate the signed record as not genuine. Such procedures and controls shall include the following: (k) Use of appropriate controls over systems documentation including: (1) Adequate controls over the distribution of, access to, and use of documentation for system operation and maintenance. (2) Revision and change control procedures to maintain an audit trail that documents time-sequenced development and modification of systems documentation.16

Attributes

Item Id: 11.10-k
Section: 11.10 Controls for closed systems
Service: aws

11.30 Controls for open systems123

11.30Persons who use open systems to create, modify, maintain, or transmit electronic records shall employ procedures and controls designed to ensure the authenticity, integrity, and, as appropriate, the confidentiality of electronic records from the point of their creation to the point of their receipt. Such procedures and controls shall include those identified in 11.10, as appropriate, and additional measures such as document encryption and use of appropriate digital signature standards to ensure, as necessary under the circumstances, record authenticity, integrity, and confidentiality.23

Attributes

Item Id: 11.30
Section: 11.30 Controls for open systems
Service: aws

11.200 Electronic signature components and controls110

11.200(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) Be used only by their genuine owners; and (3) 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.10

Attributes

Item Id: 11.200
Section: 11.200 Electronic signature components and controls
Service: aws

11.300 Controls for identification codes/passwords213

11.300-bPersons who use electronic signatures based upon use of identification codes in combination with passwords shall employ controls to ensure their security and integrity. Such controls shall include: (b) Ensuring that identification code and password issuances are periodically checked, recalled, or revised (e.g., to cover such events as password aging).9

Attributes

Item Id: 11.300-b
Section: 11.300 Controls for identification codes/passwords
Service: aws

11.300-dPersons who use electronic signatures based upon use of identification codes in combination with passwords shall employ controls to ensure their security and integrity. Such controls shall include: (d) 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.4

Attributes

Item Id: 11.300-d
Section: 11.300 Controls for identification codes/passwords
Service: aws