Agilent Response to 21CFR Part11 requirements for the Agilent ChemStation Plus

Transcription

1 Agilent Response to 21CFR Part11 requirements for the Agilent ChemStation Plus 1. Preface This document describes which requirements of the FDA s rule for electronic records and electronic signature (21 CFR Part 11) are fulfilled by the Agilent ChemStation Plus chromatographic data system. The answers are based on revision B or higher of the Agilent ChemStation and revision B or higher of Agilent ChemStore and ChemStation Plus Security Pack. 2. Applicable Sections of 21 CFR Part CFR 11 Sections ( = applicable / = not applicable) 11.1, 11.2, 11.3 Possible scenarios with ChemStation Plus operated as a closed system Electronic Record only (without signature) Electronic Signature Based upon ID Code & Password (a) (b) (a), (b), (d) (c), (e) Page 1 of 5

2 3. Response to the sections of 21 CFR Part11 Result can be: = A function to fulfil the requirement is implemented in ChemStation Plus No = Function is not implemented = not applicable Reference in 21CFR Part11 Description Result Comment Controls for closed systems (system access is controlled by persons who are responsible for the content of electronic records that are on the system) 11.10(a) 11.10(b) 11.10(c) 11.10(d) 11.10(e) Validation The computerized System shall be validated in accordance with applicable Corporate Standards and regulatory requirements to ensure Accuracy, Reliability, Consistent intended performance and the Ability to discern invalid or altered records. Ability to generate accurate and complete copies of records in human readable & electronic form. Protection of record to enable their accurate and ready retrieval throughout the record retention period. System access shall be limited to authorized individuals. Secure, time-stamped, computer generated audit trails, to independently record operator entries & actions that create, The validation of the Data System is the responsibility of the organization, which operates the system and not of the software vendor. Agilent develops its products according to the well established product lifecycle concept, which is a phase review process for soft- and hardware development, in order to ensure consistent product quality and conformity with regulation guidelines for product development. Agilent delivers a fully qualified data handling system together with all necessary services, which are needed to implement such a system to meet the requirements of the FDA regarding 21CFR Part11. Agilent uses both export functions as part of the software functionality as well as general database copy and archiving functionality to create accurate and complete copies in electronic form. All data including all audittrail data can also be printed as human readable copies of the records. Agilent ChemStation Plus offers amongst other functionality standard Oracle database storage and data management functionality as a key concept to secure and protect electronic records. But full protection in terms of regulatory agencies also includes application of additional procedural controls. These procedures must be defined by the system administrator along with a compliance expert and they must be applied to the data system. Examples could be company policies for password renewal and user management as well as data backup and restore policies. Agilent ChemStation Plus Security Pack has a secure, user-independent audit trail. The audit trail can be viewed and is saved together with the electronic record in the Page 2 of 5

3 11.10(f) 11.10(g) 11.10(h) 11.10(i) modify or delete a record. Record changes must not obscure the previous recorded information. Audit trails shall be retained & available for review & copy as long as that required for the subject e- record. Operational system checks to enforce the proper sequencing of steps. Authority checks shall ensure that only authorized users can use the system, electronically sign a record, access the computer system input or output device, alter a record and perform the specified operation. Device or terminal checks to determine the validity of the source of data input or operation. SOP's & records to prove education, training and experience of the persons who develop, maintain or use systems. database and in the archive. All result versions along with the related raw and meta data are stored in the relational database and cannot be overwritten nor deleted. All versions can be retrieved and viewed. All means for record retention are provided. The built-in archive/delete tool (client-server version only) allows for easy data transfer to other disks and or media to free up database space while keeping a complete audit-trail of all archive and delete operations. It allows secure archiving of data. A catalogue of all archive units is maintained and can be queried. Archive units that were created during the archive/delete procedure can be completely restored to the database including audit trails. Appropriate storage of and access to the media containing the archive units have to be ensured by the organization to allow retrieval in the required timeframe. Operational system checks are not as critical in analytical systems as they might be in manufacturing production control software. However, Agilent uses a clear prerun/run/postrun structure in its Run control functionality to ensure proper sequencing steps. Another example for a process that requires sequenced steps is the archive/delete procedure - records must be archived before they are allowed for deletion. Each user must logon to the software with a user-id password combination before they can use the system. This applies at initial program start AND after every inactivity timeout on the computer program. Only a successful logon to the system offers access to the chromatographic software functions such as data acquisition, data review, result approval or archiving functionality. Instrument serial numbers are transferred electronically. This is done automatically from the instrument. Agilent software developers as well as support personnel receive appropriate training to fulfil their development and maintenance tasks. Training records are kept in a company-wide training database. Details on the training curriculum of the people involved in the development of the Agilent ChemStation Plus can be viewed during an audit. In addition Agilent provides a basic familiarization for users and administrators during the installation of the product. A set Page 3 of 5

4 11.10(j) Establishment of & adherence to written SOP for system access management and responsibility of actions made under one's identifier or signature. of administrator and user training courses is available Controls for open systems (systems on which access is not controlled by the persons responsible for the content of the records that are on). Agilent ChemStation is not designed to operate as an open system Signature manifestation 11.50(a) Signed records must contain and show: 1. The printed name of the signer 2. Date & time when the signature was executed 3. Meaning of the signature 11.50(b) All items identified in 11.50(a) 1 to 3 must be subject to the same controls as for electronic records and must be included as part of any human readable form of the electronic record Signature / Record linking Signature must be linked to the record to ensure that the signature cannot be excised, copied or transferred to falsify a record Electronic signatures- General requirements (a) (b) (c) Each e-signature shall be unique to one individual. The identity of signer shall be verified before access & use of e- signature is authorized. Declaration to FDA of e-signature use prior to or at the time of such use. The printed name of the signer, the date and time stamp of the signature execution and the reason for signing are stored in a userindependent audit trail with the electronic record. A comment outlining the reason for the signature is mandatory. See comment on linking records and signatures under The Agilent database concept automatically links audit-trail table data through the database schema to the respective electronic records. This link is part of the software program and cannot be modified, or accessed without the original data dictionary and database schema. Both are property of Agilent technologies and they are not available to unauthorized users Electronic signature components and controls (a) Non biometric (a)(1) Employ at least two distinct identification components such as an identification code and password. ChemStation Plus uses User-ID/password combination for unique identification (a)(1)(i) A series of signings executed during a continuous period of controlled access: Use all electronic signature components for the first signing and at least one electronic signature For subsequent signings in a continuous signing session user ID and password are required. Page 4 of 5

5 11.200(a)(1)(ii) (a)(2) (a)(3) component for subsequent signings. One or more signing not executed during a continuous period of controlled access: Each signing shall be executed using all electronic signature components. The Signature must be used only by its owner. Irregular use must require collaboration of two or more individuals All actions including electronic signatures are covered through the time-based inactivity timeout. After an administrator-configured time, each user must re-execute their identification code. The time between two inactivity timeouts is defined as a continuos session. This continuous session ends when the inactivity timeout kicks in. Starting a new session requires a complete re-identification through user-id and password. Both User-Ids and passwords are kept unique to users. Even the system administrator only knows User-Ids as he sets up the users. The password is only known to the individual users as it is defined at each user s individual first logon. Thus this requires active collaboration with the purpose of sharing passwords to enable irregular use of somebody else identification (b) Biometrics The Agilent ChemStation does not use biometric devices Controls for identification codes / passwords (a) Uniqueness of combined identification by identification code and password Both User-Ids and passwords are kept unique to users. Even the system administrator only knows User-Ids as he sets up the users. The password is only known to the individual user as it is defined at each user s individual first logon. Thus this requires active collaboration with the purpose of sharing passwords to enable irregular use of somebody else identification (b) Periodical change of passwords Password policy configuration is part of ChemStation Plus administration functionality (d) Detection & audit trails for: all access & signing operations, any attempt of unauthorized use of a password with an immediate report to the system security units Each database has one central repository for all security violations. The system immediately reports and documents security violations. This includes the system and computer ID along with the operator name and application identification, allowing for an immediate check of the potential security leak. Page 5 of 5