Chrom&Spec 21 CFR PART 11 COMPLIANCE

§ 11.10 Electronic Records

“Chrom&Spec” uses unique check-sum algorithm along with standardized approach, based on X.509 certificates, to maintain data integrity of all data files.

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

Ampersand intensively validates software with tests, designed specifically to ensure accuracy, reliability and consistent performance.

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.

Comprehensive reports and all raw data can be made available for inspection in human-readable format.

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

All data records are stored in protected storage in write- and modification- protected files. Only authenticated users can retrieve data.

11.10 (d) Limiting system access to authorized individuals.

“Chrom&Spec” implements reliable authentication system, based on recognized cryptographic algorithms (MD5 hashing with salt values and AES encryption). “Chrom&Spec” defines several access levels for users to control access to different software functions.

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.

The secure, computer-generated, time-stamped audit trail is embedded into data file itself. It ensures data integrity during data storage and file transfer

“Chrom&Spec” ensures that record changes cannot obscure previously recorded information. All versions of data files are kept; there is no overwriting of information.

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

“Chrom&Spec” uses system checks to validate user inputs and implements wizards to guide users through permitted sequences of steps.

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.

“Chrom&Spec” security subsystem, based on recognized cryptographic algorithms (MD5 hashing with salt values and strong AES encryption) ensures that only authorized individuals can use the system. User access to particular software functions (including electronic signing of data records, altering records, managing of user records) is controlled by administrators with “access level” technology, implemented in the software.

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.

Full integration of “Chrom&Spec” with particular equipment and devices allows performing all necessary checks.

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.

All employees in Ampersand ltd. have adequate education and work experience. Records of the education and employment history of Ampersand Ltd. employees can be made available during audit of Ampersand ltd.

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.

This is responsibility of organization, which implements and uses electronic signatures, to define policies.

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

k)(1) This item is a responsibility of the end-user. (K)(2)All modifications in “Chrom&Spec” development are documented, timed stamped and audit trailed in Ampersand version-control system.

§ 11.50 Signature manifestations.

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.

“Chrom&Spec” electronic records contain the name of the signer, date and time when the signature was executed, and the meaning associated with the signature.

Both machine-readable data and human-readable screen and paper reports contain the name of the signer, date and time when the signature was executed, and the meaning associated with the signature.

§ 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.

Electronic signatures are embedded into data files to ensure long-term association. “Chrom&Spec” uses recognized cryptographic algorithms and standards (X.509 certificates, SHA1 hashing and RSA encryption) to ensure that signatures cannot be excised, copied, or otherwise transferred to falsify an electronic record.

§ 11.100 General requirements.

“Chrom&Spec” ensures that certificates, automatically generated by the software, are unique to one individual.

“Chrom&Spec” also supports secured exporting and importing of user certificates issued by other Certification Authorities. In such a case, Certification Authority must ensure that each electronic signature is unique to one individual and cannot be reused by, or 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.

This is a responsibility of the customer organization to verify the identity of the 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.

This is a responsibility of the customer organization and of the persons using electronic signatures.

§ 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. (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.

(a)(2) “Chrom&Spec” encrypts certificates and private keys with strong AES algorithm to ensure that only the certificate owner can use it. Encryption key is derived from user password with salt values and is never stored in any files. It makes it impossible to copy, transfer or falsify somehow user’s electronic signature.

(a)(3) In order to use an electronic signature user must specify login name and password. Initial password for the user is assigned by administrator. During first login user is prompted to change his password, so the combination login name /password is known to the individual only. Only the individual himself is allowed to change his password afterwards.

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

There are no electronic signatures based upon biometrics in “Chrom&Spec”.

§ 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.

“Chrom&Spec” maintains uniqueness of user login names.

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

With “Chrom&Spec” administrators can configure identification code and password periodic check and revision, including password aging.

(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.

With “Chrom&Spec” administrators can at any time disable or enable user accounts and create new user accounts.

(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.

In “Chrom&Spec” only the user himself knows his password. Software uses recognized MD5 one-way hashing with salt values to validate user password and to ensure that no one can restore a password by analyzing any records or files, created by “Chrom&Spec”.

“Chrom&Spec” can be configured in such a way that unauthorized access attempts automatically disable user account and corresponding notification is placed in system audit trail.

(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.

“Chrom&Spec” does not use devices such as tokens or cards.