JPN_cubeLMS_FDA 21 CFR Part 11 Self Check List

Regulation

Compliance

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:

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

CRScube システムは Closed systemで、一度生成されたデータファイルは変更できません。Audit Trail 機能は data loggerを含め、システムのすべての相互作用をキャプチャして修正記録が作成されます。

システム Validation(検証）は、正確性、信頼性、一貫した性能、および無効または改変された記録を識別できる能力を保証し、2つの形態のシステム検証と電子記録の検証機能を提供します。

1. システム検証手順は SOP 151 Software Developmentに従ってシステムを開発し、要件、デザイン設計、および設計に基づいて実施されたテスト文書などの重要な活動を文書化します。

2. 電子記録の検証を実施します。

   1. 入力されたデータの検証手順を実行する機能

      • 文字、数値、日付 Type 入力データチェック

      • Field Check: 必須データ入力チェック

      • Edit Check: 正常範囲の値を外れる場合は Warning Messageまたは確認作業を行うようにします

[11.10b] 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.

Role & Privilegeに従って設定されたユーザーにより電子記録の確認およびコピーの作成が可能です。 ダウンロードしたファイルは、人が読める形式で、完全かつ正確です。 必要に応じて、携帯媒体 (例 : CD-ROM) に印刷またはコピーでき、後で監査 / 検査のために保管できます。

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

データ保護のための手順を提供します。

• データ上の変更について確認および警告メッセージを出力します

• データ修正の理由(Editing Reason)入力機能を提供します

[11.10d] Limiting system access to authorized individuals.

認証された個人に対してのみシステムにアクセスできるようにし、ID/PW を使用します。

• ID/PW 入力によるシステムアクセス

• 5回 Login 失敗時にユーザーの Lock が行われ、→ パスワードの再設定によりアクセス可能

• 設定された Role & Privilegeにより、ユーザーのシステムアクセスが制限されます

[11.10e] 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.

cubeLMS は、運用中に発生した変更事項を Audit Trailを通じて、システム自体によるタイムスタンプ、ユーザー ID、入力値、変更事由の情報から追跡できます。

Data Audit Trail の項目は次のように構成されています。

• No. : Audit Trail の Row Number

• Date/Time : Dataが入力 & 修正された Date & Time

• User : Dataを入力 & 修正した User

• Value : 入力 & 修正された Value 値

• Reason : Data 修正時に Userが入力した事由

1. Data の削除は List に表示されませんが、実際には Data は削除されません。

2. Audit Trail は read-only で表示され、修正および削除はできません。

3. Audit Trail は Data が保管される期間だけ保管され、システム内でいつでもアクセスできます。

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

cubeLMS は、各個人ごとの Training Record を管理するシステムです。

ユーザー Flow は管理者と一般ユーザーで区分され、管理者は Lecture 作成 → 修正 → 受講内容管理の手順で進みます。

一般ユーザーは登録済みの講義確認 → 受講 → 受講内容管理の手順で進みます。

[11.10g] 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.

cubeLMS は、許可された人のみが ID を作成でき、ユーザーを特定できます。登録済みユーザーは Role & Privilege に従ってシステムの使用が制限されます。

• アクセス権限が付与された Company に限り、アクセスの参照、修正が可能です。

• 参照権限のみを持つ場合、修正、入力機能が制限されます。

• Lecture の作成および修正に対する権限が制御されます。

• 管理的な活動(ユーザー管理、システム設定など)を行う権限が制御されます。

[11.10h] Use of device (e.g., terminal) checks to determine, as appropriate, the validity of the source of data input or operational instruction.

cubeLMS は別途 device を使用しないため、適用対象ではありません。

[11.10i] Determination that persons who develop, maintain, or use electronic record / electronic signature systems have the education, training, and experience to perform their assigned tasks.

SOP 102 Personal Training に従って作業に関連する教育を実施し、その実施記録を各自の教育記録として文書化しています。

End User に対する Training を実施し、システム上で User Manual を提供しています。

[11.10j] 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.

Sponsorと CRO組織に該当するプロセスです。

[11.10k] 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.

cubeLMS は次の SOP に従って、システム関連文書を作成、管理、および配布しています。

• システム開発に関連する成果物の作成管理

  • SOP 151 Software Development

• 文書の配布、管理、アクセスに関する管理プロシージャを提供

  • SOP 112 Document Control

  • SOP 121 System Manual

  • SOP 155 Change and Configuration Management

Regulation

Compliance

[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.

cubeLMSはClosed Systemのため適用対象ではありません。

Regulation

Compliance

[11.50a] 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.

cubeLMSは電子署名を実施しないため、適用対象ではありません。

[11.50b] 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).

cubeLMSは電子署名を実施しないため、適用対象ではありません。

Regulation

Compliance

[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.

cubeLMSは電子署名を実施しないため、適用対象ではありません。

Regulation

Compliance

[11.100a] Each electronic signature shall be unique to one individual and shall not be reused by, or reassigned to, anyone else.

cubeLMSは電子署名を実施しないため、適用対象ではありません。

[11.100b] 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.

Sponsor と CRO の組織に該当するプロセスです。

[11.100c] 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.

Sponsor と CRO の組織に該当するプロセスです。

Regulation

Compliance

[11.200a] 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;

(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.

cubeLMSは電子署名を実施しないため、適用対象ではありません。

[11.200b] Electronic signatures based upon biometrics shall be designed to ensure that they cannot be used by anyone other than their genuine owners.

cubeLMSは生体認証をサポートしていません。

Regulation

Compliance

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:

[11.300a] Maintaining the uniqueness of each combined identification code and password, such that no two individuals have the same combination of identification code and password.

cubeLMSはユーザー ID / Password の組み合わせが常に一意であることを確認します。ユーザー ID の変更はできません。

[11.300b] Ensuring that identification code and password issuances are periodically checked, recalled, or revised (e.g., to cover such events as password aging).

cubeLMSはログイン Password が90日ごとに変更されるよう制御されています。

[11.300c] 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.

cubeLMSはIDや Passwordを生成するデバイスを提供していません。IDや Passwordを忘れた場合は、Find your ID, Reset Passwordを通じてパスワードを初期化した後、システムにアクセスできます。

[11.300d] 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.

システムへのログインに失敗した場合は、残りの試行回数を表示し、5回ログインに失敗するとユーザーアカウントを Lock した後、アクセスを制御します。

[11.300e] 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.

cubeLMSは トークン または カードのようなデバイスを使用しません。