21 CFR Part 11 Compliance
JMobile Studio includes a set of functions for responding to the requirements specified in FDA 21 CFR Part 11. The standard is intended to provide a solution for securely handling electronic records and electronic signatures in industrial applications.
The table lists all the requirements specified by the regulation and reports the functions available in JMobile Studio for compliance.
FDA 21 CFR Part 11 compliance is optional during application development and the application developer is responsible to configure the application in the proper way.
| Chapter | Description | JMobile Studio compliance level |
|---|---|---|
| 11.10(a) | (a) Validation of systems to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records. |
Reports generated by JMobile Studio can be signed using x.509 Certificates. A certificate that includes the public key, necessary to verify the signature of reports, will be exported with the report. References: |
| 11.10(b) | 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. Persons should contact the agency if there are any questions regarding the ability of the agency to perform such review and copying of the electronic records. |
Application developer can select the resources (process values, alarms, etc.) whose changes will be tracked to the audit trail. Each change of the selected resources will be recorded with the name of the operator doing the change. The audit trail reports can be exported to .csv or .pdf files. References: |
| 11.10(c) | Protection of records to enable their accurate and ready retrieval throughout the records retention period. |
Applications can be developed to self-generate signed reports to external memory or network folders at predefined interval (e.g. at the end of the day) or when circular buffer is full. User is responsible to keep these reports saved for the retention period. References: |
| 11.10(d) | Limiting system access to authorized individuals. |
Application developer is responsible for the appropriate security configuration of the application. References: |
| 11.10(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. |
Audit trail records are stored using a circular buffer (this is to ensure that the device will not run out of memory). Audit trails cannot be modified by the operator. Each record contains a sequential number to easily check the presence of all records. The application can be developed to save/export a copy of the data at regular intervals (e.g. at the end of each day); operator is responsible for storing copy of reports in a safe place. References: |
| 11.10(f) | Use of operational system checks to enforce permitted sequencing of steps and events, as appropriate. | Macros or JavaScript can be used to configure command sequences in the application. |
| 11.10(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. |
The HMI application can be configured
References: |
| 11.10(h) | Use of device (e.g., terminal) checks to determine, as appropriate, the validity of the source of data input or operational instruction. |
Resources can be configured to be accessible only from selected user groups. List of allowed IP address can be configured from the User Management settings. References: |
| 11.10(i) | Determination that persons who develop, maintain, or use electronic record/electronic signature systems have the education, training, and experience to perform their assigned tasks. | Application developer is responsible to define and assign the appropriate user rights to each user that have access at the HMI device |
| 11.10(j) | The establishment of, and adherence to, written policies that hold individuals accountable and responsible for actions initiated under their electronic signatures, in order to deter record and signature falsification. | Application developer is responsible for establishing appropriate procedures. |
| 11.10(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. |
Application developer is responsible for establishing appropriate procedures. |
| 11.30 | Persons 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. | JMobile Studio has been designed for operation in closed systems. |
| 11.50(a) |
Signed electronic records shall contain information associated with the signing that clearly indicates all of the following: (1) The printed name of the signer; (2) The date and time when the signature was executed; and (3) The meaning (such as review, approval, responsibility, or authorship) associated with the signature. |
All records will be added to the audit trail with time stamp and user id of logged user. References: |
| 11.50(b) | The items identified in paragraphs (a)(1), (a)(2), and (a)(3) 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). | |
| 11.70 | 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. | Application developer is responsible for avoiding using the macros that permit the import/export of user passwords. |
| 11.100(a) | Each electronic signature shall be unique to one individual and shall not be reused by, or reassigned to, anyone else. | System will ensure that two users with the same id cannot be defined. It is user responsibility to avoid removal and reassignment of the same user id to a different user. |
| 11.100(b) | Before an organization establishes, assigns, certifies, or otherwise sanctions an individual's electronic signature, or any element of such electronic signature, the organization shall verify the identity of the individual. | User responsibility. |
| 11.100(c) |
Persons using electronic signatures shall, prior to or at the time of such use, certify to the agency that the electronic signatures in their system, used on or after August 20, 1997, are intended to be the legally binding equivalent of traditional handwritten signatures. (1) The certification shall be submitted in paper form and signed with a traditional handwritten signature, to the Office of Regional Operations (HFC-100), 5600 Fishers Lane, Rockville, MD 20857. (2) Persons using electronic signatures shall, upon agency request, provide additional certification or testimony that a specific electronic signature is the legally binding equivalent of the signer's handwritten signature. |
User responsibility. |
| 11.200(a) |
(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. |
JMobile Studio Security functions are based on the combination Username/ Password. |
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(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. |
Users must enter name and password to access the system. Critical actions can be configured to require entering again the password before execution is started. References: |
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(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. |
Each user is responsible to not divulge own password. Passwords defined by administrator for first access can be forced to be redefined at first use. References: |
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| 11.200(b) | Electronic signatures based upon biometrics shall be designed to ensure that they cannot be used by anyone other than their genuine owners. | JMobile Studio does not support biometrics. |
| 11.300(a) | Maintaining the uniqueness of each combined identification code and password, such that no two individuals have the same combination of identification code and password. | It is not possible to define to define two users with the same User ID |
| 11.300(b) | Ensuring that identification code and password issuances are periodically checked, recalled, or revised (e.g., to cover such events as password aging). |
System can be configured to force each users to define a new and different password after a configurable number of days References: |
| 11.300(c) | Following loss management procedures to electronically deauthorize 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. |
Users can change their password at any time. Administration can redefine each user's password and force them to redefine at the first login. References: |
| 11.300(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. | Failed logging attempts are logged to audit trail. |
| 11.300(e) | Initial 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. | User is responsible for ensuring appropriate measures. |