MetricStream's 21 CFR Part 11 Compliance

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Overview of 21 CFR Part 11
The FDA introduced 21 CFR Part 11 in to effect on August 20, 1997. All companies and organizations that are in industries regulated by the FDA must follow these regulations. These apply primarily to administrative practice and procedure in the handling of electronic records, use of electronic signatures, and in reporting and record keeping requirements. The main subparts of Part 11 are:

Subpart A
General Provisions

§ 11.2 Implementation.
Per the requirements under 11.2, all documents or parts of a document to be submitted must be identified by the customer as being present in public docket No. 92S–0251(which contains the type of submission the agency accepts in electronic form). This docket also specifies the agency receiving unit(s) (e.g., specific center, office, division, branch) to which such submissions may be made. Documents to agency receiving unit(s) not specified in the public docket will not be considered as official if they are submitted in electronic form; paper forms of such documents will be considered as official and must accompany any electronic records.

§ 11.3 Definitions.
The following definitions of terms that apply to this part are provided for reference purposes:

1. Act means the Federal Food, Drug, and Cosmetic Act (secs. 201- 903 (21 U.S.C. 321-393)).
2. Agency means the Food and Drug Administration.
3. Biometrics means a method of verifying an individual's identity based on measurement of the individual's physical feature(s) or repeatable action(s) where those features and/or actions are both unique to that individual and measurable.
4. Closed system means an environment in which system access is controlled by persons who are responsible for the content of electronic records that are on the system.
5. Digital signature means an electronic signature based upon cryptographic methods of originator authentication, computed by using a set of rules and a set of parameters such that the identity of the signer and the integrity of the data can be verified.
6. Electronic record means any combination of text, graphics, data, audio, pictorial, or other information representation in digital form that is created, modified, maintained, archived, retrieved, or distributed by a computer system.
7. Electronic signature means a computer data compilation of any symbol or series of symbols executed, adopted, or authorized by an individual to be the legally binding equivalent of the individual's handwritten signature.
8. Handwritten signature means the scripted name or legal mark of an individual handwritten by that individual and executed or adopted with the present intention to authenticate a writing in a permanent form. The act of signing with a writing or marking instrument such as a pen or stylus i preserved. The scripted name or legal mark, while conventionally applied to paper, may also be applied to other devices that capture the name or mark.
9. Open system means an environment in which system access is not controlled by persons who are responsible for the content of electronic records that are on the system.

Subpart B
Electronic Records

§ 11.10 Controls for closed systems.
(a) Validation of systems to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records.

• Ultimately, the customer is responsible for validation of the MetricStream solution. MetricStream provides a set of products and services for the validation of the software. These services provide the customer with the tools and documentation to conduct the validation effort in an efficient and seamless manner. MetricStream offers an Installation Certification Service and an Operational Certification Service that ensure that the operating version of the software in the installed system configuration conforms to prepackaged validation tests.

(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.

• When any data is collected by MetricStream software, it is stored in an Oracle database for future retrieval. MetricStream software has multiple checks to ensure that partial records are not ‘committed’ to the database, and that integrity of data in the database is maintained. Users with the right level of authority can view and print the data and reports of files at any time. Data and reports can be electronically mailed and/or exported in to alternate formats such as Microsoft Excel. The customer is responsible for granting authority to personnel to allow them to view and print specific reports and data.

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

• All records created in the MetricStream solution are stored in a secure Oracle database. The customer is ultimately responsible for the archival and backing up of the records in the database. It is also necessary to have a procedure for retrieval of records. MetricStream provides recommended backup, maintenance, and retrieval procedures for the database in its Operational Certification Service documentation. Following these procedures provide a high level of protection to the data stored in the database. Customers must also set procedures to ensure that both the original data and backups of the data are available for the entire retention period.

(d) Limiting system access to authorized individuals.

• MetricStream security protocols utilize multiple password security to ensure the highest level of limitation of system access. A log-on user id and password is required by the application every time a new session is started. In addition, any station that is left idle for more than 5 minutes requires re-authentication when the user returns. To limit access against situations when a user leaves a station idle for a period of time, all documents and records require a second password for submission to the database.

(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.

• MetricStream Solution stores every entry of a record independently. When the entry is a modification of a previous record, this entry is stored as a new record in our system, thus not obscuring the previous record in any way. An audit trail with time stamps is maintained of all creations, modifications, or deletions made in the system. In addition, every time pre-specified fields are changed MetricStream Solution also captures the “Reason for Change”. The system administrator should ensure that these trails are retained for the period stipulated by the FDA.

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

• MetricStream’s Process Flow Designer provides systems checks that ensure that events can only ‘travel’ down a permitted path (e.g., Step A and B have to be completed before Step C is initiated). For parameter and data collection, certain fields that are tagged as mandatory have to be filled before they can be submitted to the system

(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.

• MetricStream security protocols utilize multiple password security to ensure the highest level of limitation of system access. A log-on user id and password is required by the application every time a new session is started. In addition, any station that is left idle for more than 5 minutes requires re-authentication when the user returns. To limit access against situations when a user leaves a station idle for a period of time, all documents and records require a second password for submission to the database. MetricStream allows for different passwords to be set for each type of transaction (such as record entry, record update, record approval, etc.)

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

• MetricStream solution is a fully web-based software package that can be delivered through the customer’s corporate Intranet. After it is installed, access at the device level needs to be controlled through firewall and VPN administration. Access to MetricStream solution may be opened up to third parties that are part of an extended secure network controlled by the customer.

(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.

• MetricStream provides training for the software suite. It is the ultimate responsibility of the customer to ensure that persons that use the suite have the education, training, and experience to perform their assigned tasks.

(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.

• The customer needs to establish and adhere to written policies that hold individuals accountable and responsible for actions initiated under their electronic signatures

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.

• MetricStream solution provides documentation for operation and maintenance of its product in soft and hard copy formats. It is the responsibility of the customer to ensure that appropriate controls are maintained over the distribution of, and access to this documentation. We shall inform the customer, and ship to the customer immediately any changes in systems documentation. MetricStream follows strict procedures for revision and change control of its documentation and software.

• MetricStream solution is a closed system as per the definition set forth in Section 11.3 above. Access at all points to MetricStream Solution is restricted to authorized users.

§ 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.

(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).

• MetricStream Solution Reports and electronic records contain and indicate the name of the signer and the date and time when the signature was executed. In addition, the meaning associated with the signature is also stored and reported. The items identified are stored and subject to the same controls as the electronic record, and are included in any printout or display of the record.

§ 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.

• The electronic signature is comprised of two parts – the user id and the password. The user id is linked to respective electronic records. To ensure that the electronic signature cannot be copied or transferred, the password component of the signature is not stored with the record. By maintaining the user id with the record, it is ensured that the signature cannot be excised.

Subpart C
Electronic Signatures

§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.

• MetricStream Solution ensures that the electronic signature (the user id/password combination) is unique at any point in time. It is the responsibility of the customer to ensure that a user id assigned to one individual is not reassigned to anyone else.

§11.100 General requirements.
Each electronic signature shall be unique to one individual and shall not be reused by, or reassigned to, anyone else.

• MetricStream Solution ensures that the electronic signature (the user id/password combination) is unique at any point in time. It is the responsibility of the customer to ensure that a user id assigned to one individual is not reassigned to anyone else.

(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.

• It is the responsibility of the customer organization to ensure that before they verify the identity of the individual before they assign a user id to that individual.

(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.

• The customer organization is entirely responsible for managing the 11.100 c) (1) and (2) clauses listed above.

§ 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.

• MetricStream Solution employs two distinct identification components - a user id and a 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.

• MetricStream security protocols utilize multiple password security to ensure the highest level of limitation of system access. A log-on user id and password is required by the application every time the user first logs in to the system. In addition, any station that is left idle for more than a predefined number of minutes requires re-authentification when the user returns. Every document requires the author to use a second document-level password for submission of the document. Therefore, the first signing is executed using all electronic signature components. To limit access against situations when a user leaves a station idle for a period of time, all subsequent signings, documents and records require a second password (electronic signature component) for submission to the database. MetricStream allows for different passwords to be set for each type of transaction (such as record entry, record update, record approval, etc.)
  
  (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.
  
  
• MetricStream Solution ensures this by forcing the user to log on with the user id and password every time a new session is initiated.

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

• It is the customer’s responsibility that the components of a user’s electronic signature (user id and all passwords) are used only by the genuine owner of the signature. The customer must clearly explain to all users the penalty associated with sharing an electronic signature with others.

(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.

• MetricStream Solution only allows the assigned user (genuine owner) to use their individual electronic signature. The system administrator may, however, reset all assigned owners' electronic signatures. A log is maintained if the system administrator does reset any assigned owner's electronic signature. The customer must define procedures to ensure that if a system administrator is going to reset any user's electronic signature, or if a system administrator is going to log in as another user, such an activity must be done in the presence of another individual.

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

• MetricStream software electronic signatures are not based upon biometrics.

§ 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:

(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.

• MetricStream software ensures that the electronic signature (the user id/password combination) is unique at any point in time. It is the responsibility of the customer to ensure that a user id assigned to one individual is not reassigned to anyone else.

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

• MetricStream software ensures that the login password component of the electronic signature is changed every month. Any other procedures for recalling and revising passwords need to be set forth by the customer.

(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.

• When a user informs supervisors or the system administrator that an electronic signature may have been compromised, the electronic signature can be immediately deactivated in the MetricStream software. The customer is responsible for establishing any further loss management procedures and controls.

(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.

• When a user attempts to log in to the MetricStream system thrice with an invalid electronic signature, MetricStream software immediately locks out access to that user id and/or session. All such attempts are logged in the MetricStream software’s repository, and the system administrator is immediately alerted of such events.

(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.

• MetricStream software does not use any devices in its electronic signature.