Sec. 11.10 Controls for Closed Systems

Validation of systems to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records.

Manual checks of the system to discern invalid or altered records. TMS provides viewers for audit tables to allow for user-friendly search and comparison.

See technical notes for instructions on how to use the audit viewers.

Sec. 11.10 Controls for Closed Systems

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.

All electronic records generated in TMS are accurate, complete, and presented in a human-readable format. These records can be exported into several industry standard formats, such as Word, Excel, and HTML.

Sec. 11.10 Controls for Closed Systems

(c) Protection of records to enable their accurate and ready retrieval throughout the records retention period.

(c) Yes – training records and documents with electronic signatures are stored in a secure web server. Access to the TMS-managed records is limited to that portion of the total record retention time allocated to access by source application and database manager. Long-term digital preservation strategies are to be applied for the balance of the record life time

Sec. 11.10 Controls for Closed Systems

(d) Limiting system access to authorized individuals.

(d) Yes – TMS uses Microsoft NT security with logon and password. Direct access to records is controlled via administrators. Procedures to limit system access to authorized individuals are required. TMS access to records has extensive security based on the permissions of the individual users

Sec. 11.10 Controls for Closed Systems

(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.

(e) Yes – Final Signature, reviewing, training records, and other activities against documents are placed in a table, as well as date and time-stamping of the signer. Audit trails in the SQL database cannot be obscure without a creation of an audit record, which cannot be individually deleted.

Sec. 11.10 Controls for Closed Systems

(f) Use of operational system checks to enforce permitted sequencing of steps and events, as appropriate.

(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.

(f) TMS does not enforce sequencing. Sequencing of business process has to be enforced by Procedural controls.

(g) Procedural Requirements along with technology provides the security necessary to electronic signatures. Notifications of electronic records/signatures are available to authorized individuals.

Sec. 11.10 Controls for Closed Systems

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

(h) TMS does not check for the validity of an input device or computer on the network. This action, if important to a regulated activity, has to be implemented via procedural controls.

Sec. 11.10 Controls for Closed Systems

(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.

(i) Not applicable to TMS as this requirement is a function of controlled and managed use of technology in regulated operations.

Sec. 11.10 Controls for Closed Systems

(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.

(j) Not applicable to TMS as this requirement is a function of controlled and managed use of technology in regulated operations.

Sec. 11.10 Controls for Closed Systems

(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.

(1) Not applicable to TMS as this requirement is a function of controlled and managed use of technology in regulated operations.

(2) Not applicable to TMS as this requirement is a function of controlled and managed use of technology in regulated operations.

Sec. 11.30 Controls for open systems

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 Sec. 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.

The use of TMS over the Internet infrastructure may require more robust security utilities for sensitive and critical information.

Sec. 11.50 Signature manifestations

(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.

Documents and training records are created when specific signature activities are created for the user. Users log on the system using their network login and password. Signature activities are authenticated using this logon/password. During continuous control, the password is required to create an electronic signing of either a document or training/awareness signature.

Archive activity reports that are available for searching, viewing, and printing enable users to see all activities that created the e-signatures, both current and archived. These reports display the name of the signer, the date and time of the signing, and a user-definable description of the e-signature.

Sec. 11.50 Signature manifestations (cont.)

(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).

All electronic records are available in readable format. Audit trails (if turned on) are provided with a program to convert the GUID (global unique identifier – see notes below) into readable format.

Archive activity reports that are available for searching, viewing, and printing enable users to see all activities that created the e-signatures, both current and archived. These reports display the name of the signer, the date and time of the signing, and a user-definable description of the e-signature.

Sec. 11.70 Signature/record linking

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.

Signatures cannot be excised, copied, or transferred because all e-signatures are linked to users and documents using a GUID (unique) number, which is interdependent on the application environment. There is no way to modify a signature in the environment without using developer tools and having proper permissions. These are not available to the normal user.

Subpart C –Electronic Signatures

Sec. 11.100 General requirements

(a) Each electronic signature shall be unique to one individual and shall not be reused by, or reassigned to, anyone else.

TMS must operate in a Microsoft NT environment (Server 2000). This provides for the authentication of users prior to entry into the network. Companies must use both methods of authentication (login/password) to create the environment for 21 CFR Part 11.

Sec. 11.100 General requirements

(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.

(b) Not applicable to TMS as this requirement is a function of controlled and managed use of technology in regulated operations.

Sec. 11.100 General requirements

(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.

(c) (1) (2) Not applicable to TMS as this requirement is for establishments filing with the Agency as users of electronic records and electronic signatures in regulated operations.

c. 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.

(1) Not applicable to TMS as this requirement is a function of controlled and managed use of technology in regulated operations.

c. 11.200 Electronic signature components and controls

(2) Be used only by their genuine owners; and

(2) Not applicable to TMS as this requirement is a function of controlled and managed use of technology in regulated operations.

c. 11.200 Electronic signature components and controls

(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.

(3) Not applicable to TMS as this requirement is a function of controlled and managed use of technology in regulated operations.

c. 11.200 Electronic signature components and controls

(b) Electronic signatures based upon biometrics shall be designed to ensure that they cannot be used by anyone other than their genuine owners.

Not applicable to TMS as this requirement is a function of controlled and managed use of technology in regulated operations.

Sec. 11.300 Controls for identification codes/passwords.

Persons 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:

Not applicable to TMS as this requirement is a function of controlled and managed use of technology in regulated operations.

Sec. 11.300 Controls for identification codes/passwords

(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.

(a) Not applicable to TMS as this requirement is a function of controlled and managed use of technology in regulated operations. NT network security does not allow for two individuals to have the same combination of identification.

Sec. 11.300 Controls for identification codes/passwords

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

(b) Not applicable to TMS as this requirement is a function of controlled and managed use of technology in regulated operations.

Can be included in the network security.

Sec. 11.300 Controls for identification codes/passwords

(c) 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.

(c) Not applicable to TMS as this requirement is a function of controlled and managed use of technology in regulated operations.

Sec. 11.300 Controls for identification codes/passwords

(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.

(d) The TMS technology tool and platform architecture do not support automatic policing and alarms for breaches of security. It is recommended that this requirement be a function of controlled and managed use of technology in regulated operations.

Sec. 11.300 Controls for identification codes/passwords

(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.

(e) Not applicable to TMS as this requirement is a function of controlled and managed use of technology in regulated operations.