As of version 6.0, BioNumerics can be used in an FDA 21 CFR Part 11 compliant setting. The module Audit Trails & Versioning together with the user and security features in the Database Sharing Tools module provides all the tools and functions required for keeping electronic records. The compliance is applicable to all BioNumerics components and functions and extends to all BioNumerics plugin tools.
The flexible object-oriented database design allows individual components of the database (objects) to be managed in different audit regimes according to the local requirements (full-tracking, only logging, restoring allowed or not, overwriting deleted allowed or not, etc.). For example, all experimental data and sample information (fingerprints, characters, sequences, information fields...) can be fully audited along with the entire processing flow, while comparisons (clusterings, dimensionings) can be left unaudited or logged only.
The Audit Trails & Versioning tools add great power and value to one of BioNumerics' cornerstones, the database. In terms of user-friendliness, flexibility and possibilities, it goes far beyond the requirements of FDA 21 CFR Part 11, making the system also an invaluable asset for institutions and companies that do not require this compliance but have interest in the increased data management power, i.e.:
Below is an extract from FDA's Code of Federal Regulations, Title 21, containing the requirements for Electronic Records and Electronic Signatures, and the implementation for each requirement in BioNumerics.
PART 11—ELECTRONIC RECORDS; ELECTRONIC SIGNATURES
Subpart B—Electronic Records
11.10 Controls for closed systems.
11.30 Controls for open systems.
11.50 Signature manifestations.
11.70 Signature/record linking.
Subpart C—Electronic Signatures
11.100 General requirements.
11.200 Electronic signature components
and controls.
11.300 Controls for identification codes/passwords.
Authority: Secs. 201–903 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321–393); sec. 351 of the Public Health Service Act (42 U.S.C. 262).
Subpart B—Electronic Records
§ 11.10 Controls for closed systems.
Persons 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.
Several tools assist in achieving this: audit trails, modification privileges, lock/unlock, consistent backup strategy…
(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.
Audit trails allow the creation of both human readable reports and detailed XML exports that contain the full state of any record at any time.
(c) Protection of records to enable their accurate and ready retrieval throughout the records retention period.
Data is never removed in the database; all versions are stored. The database itself should be properly backed up.
(d) Limiting system access to authorized individuals.
Authentication control can be enforced at the level of the OS, the relational database, and BioNumerics (user and security tools).
(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.
The BioNumerics audit trail system meets all these requirements.
(f) Use of operational system checks to enforce permitted sequencing of steps and events, as appropriate.
BioNumerics has a sophisticated system of users and privileges that allows fine tuning of permitted and prohibited actions for each authenticated user. In addition, custom scripts can be developed that execute, verify and validate specific required workflows.
(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.
See previous item.
(h) Use of device (e.g., terminal) checks to determine, as appropriate, the validity of the source of data input or operational instruction.
BioNumerics checks the data integrity before updating it in the database. In addition, custom scripts can be developed that generate specific data entry forms and check the validity of the input data against a set of rules
(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.
To be provided by customer.
(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.
To be provided by customer.
(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.
To be provided by customer.
§ 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 § 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.
Controls for open system should be addressed at the level of data storage (e.g. encryption of databases or hard disk volumes).
§ 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.
The BioNumerics signature system includes these items with every 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).
BioNumerics keeps a full history of each signature ever applied to an object, even previous versions.
§ 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.
BioNumerics uses sophisticated cryptographic methods to link a signature to the document content (RSA).
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.
Every user in BioNumerics is unique and can never be reused.
(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.
To be implemented by customer.
(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.
To be provided by customer.
(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.
To be provided by customer.
§ 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.
Enforced by BioNumerics.
(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.
Enforced by BioNumerics.
(2) Be used only by their genuine owners; and
The authentication system enforces this.
(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.
To be implemented by the customer.
(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
§ 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.
Enforced by BioNumerics.
(b) Ensuring that identification code and password issuances are periodically checked, recalled, or revised (e.g., to cover such events as password aging).
Optionally enforced by BioNumerics.
(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.
Signature keys can be revoked and replaced by authorized users of the system.
(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.
Possible through the logging possibilities of BioNumerics.
(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.
Not applicable.
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