PR GB. 21 CFR part 11 Compliance

Transcription

1 PR GB J 21 CFR part 11 Compliance

2 21 CFR Part 11 This describes the FDA (Food and Drug Administration) requirements for handling electronic records that are created, modified, maintained, archived, retrieved and transmitted in accordance with the requirements set forth in the FDA regulations. It also describes the criteria under which the agency considers electronic signatures and their associated electronic records to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper. Areas of application: Sterilization, Freeze-drying Environmental Chambers Aseptic Fillers/ Packaging Cold Storage Blending Operations Power Generation Utility plant monitoring Electronic signature An electronic signature associates the measurement data acquired by the paperless recorder with a signature. 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 that individual's handwritten signature. An electronic signature includes: the name of the signatory, date and time of execution of the signature, and the implication (significance) of the signature (e.g. checking, approval,...) Audit Trail Audit trail records cover modifications to system components that are significant for the recording and analysis of GMP-relevant data. Audit trail records are inseparably linked to electronic records. Electronic records Electronic record means any combination of text, graphics, data, audio or pictorial material, and other information representation in digital form that is created, modified, maintained, archived, retrieved or distributed by a computer system. Electronic records as understood by 21 CFR Part 11 are: GMP-relevant, electronically generated, stored on a non-volatile medium, can be accessed and interpreted by technical means, and have been created after August 20 th GMP (Good Manufacturing Practice) GMP are rules laid down to ensure good practice in manufacture. GMP data GMP data are data that arise during manufacture, checking, packing, warehousing and distribution of a product, and which directly affect the quality of a product, form part of record documentation, and can be inspected by the appropriate authorities. Responsibilities System owner validates his process and maintains it in the validated condition. Administrator works on behalf of the system owner; assigns access authorizations for the system components. User use the system components in accordance with the authorizations that have been assigned to them.

3 Hardware components 6 to 36 universal measurement inputs data storage on CompactFlash card, internally: MB, externally: unrestricted recorder configuration from keys or PC min. storage cycle 125 msec RS232 or RS485 data transmission via MODbus protocol PROFIBUS: transmit measurement data and texts to the LOGOSCREEN es Ethernet / MODBus TCP / IP: transmit measurement data, user lists and configuration data to the LOGOSCREEN es fetch measurement data and configuration data from the recorder access control by means of a user list audit trail components Software components components for controlling system access and for executing electronic signatures Security Manager software components for keeping PC audit trails Audit Trail Manager software PC Security Manager software System and security components Audit trail functionality All changes to the device software of the LOGOSCREEN es and the PC software components are recorded and documented in the audit trail. PC audit trail All changes to the PC software components of the LOGOSCREEN es are recorded and documented in the PC audit trail. The audit trail functionality is a component of all PC programs (PCA3000, PCC, Setup program, PCAT, PCS). Device audit trail data are shown in the evaluation software PCA3000. Audit trail entries cannot be altered or deleted, and are inseparably linked to the electronic records. Additional PC system components Setup software PCA 3000 PCC The PC Security Manager software ensures that only authorized persons can gain access to the system components and execute electronic signatures on electronic records. Setup software The LOGOSCREEN-es setup software is a configuration software for project design, commissioning and diagnosis. Setup data can be read out from the recorder or transferred to the recorder via the interface or Compact- Flash card.

4 The setup software with teleservice is a new feature. Teleservice can be used for online polling of the recorder data. The data are shown solely in alphanumerical form (not as diagrams). PC Evaluation software PCA3000 Using the PC evaluation software PCA3000, LOGOSCREEN es data (including the device audit trail data) are archived, analyzed and evaluated. LOGOSCEEN es data can be read into a PC and archived by means of the CompactFlash card, or via the interface. In the JUMO PCA3000, users that have been authorized by the administrator can electronically sign archived batch data or data for a defined time period. An electronic signature includes: the name of the signatory the time stamp the significance of the signature The device audit trail entries are stored in the audit trail register. Using the Back up data function, you can copy data from an archive for general data backup. We offer you: Tamper-proof data storage Process data are stored in an unpublished binary data format. Storage medium in the recorder: CompactFlash card. A high level of access control security Access to the system (device and PC components) is managed through user lists and rights files. A software program (Security Manager) has been developed for administrators to create user lists/ rights files. Traceability of system changes Logging in to/logging out from the system, modifications of the device configuration, modification of user lists, etc., are all recorded in a device and a PC audit trail. Audit trail data are inseparably linked to the process data. Data archiving The data recorded by the LOGOSCREEN es can be archived both locally and on network servers. Device data are stored in an archive, where they are made available for analysis and evaluation. The raw data present in the archive remain unaffected during analysis (high data security). Backing up process data We support your data backup through our PC evaluation software PCA3000. Process data can be backed up with regard to time, configuration, batch or signature. Backed up data can be read directly through the PCA3000. Advice/ Training We are happy to answer fundamental questions arising from 21 CFR Part 11 compliancy, train your staff on our system and support you during the creation of the validation documents. PCA Communications software The PCA Communications software (PCC) enables the transfer of data from the LOGOSCREEN es to the PC, via the serial interface (cable or modem) and Ethernet (TCP/ IP).

5 Examples of different security levels Delivery ex-works Fulda: The recorder is supplied ex-factory with a default user list User: Master Password: 9200 Rights: all rights for device User: Users Password: 0 Rights: limited rights for device Security level 1 PC Administrator User User LOGOSCREEN es 1. Installation of the PC Security 1. Installation of the required PC 1. A user list with up to 30 users Manager software with software components with is set up by the administrator license numbers on the license numbers on the in the PC Security Manager administrator PC. users' PCs. software and transferred to 2. Creation of PC/ device 2. Commissioning of the software the device. user lists. without password. 2.Only the persons listed in the 3. The global security settings Access authorization is user list are allowed to log in the Security Manager controlled solely by the in to the device, using their remain as set at the factory. Windows operating system individual passwords. during log-in to PC. 3. All users are given unlimited 3. All users are given unlimited rights to the device rights for the programs (can be defined in the they are using form of a user profile). (can be defined in the form of a user profile). 4.Data can be read out from the device through Compact-Flash card Installation of the PC Security 1. Installation of the required PC 1. see security level 1 Manager software with license software components with 2. see security level 1 numbers on the license numbers on the 3. User rights are allocated administrator's PC. users' PCs. task-related by the 2. Creation of PC/ device. 2. Commissioning of the software administrator user lists. without password (can be defined in the form 3. The global security settings (see security level 1). of a user profile). in the Security Manager are 3. The rights of the users for 4. see security level 1 configured to customer specification. the programs they are using are restricted by the administrator (can be defined in the form of a user profile). 1. Installation of the PC Security 1. Installation of the required PC 1. see security level 2 Manager software with software components with 2. see security level 2 license numbers on the license numbers on the 3. see security level 2 administrator's PC. users' PCs. 4. Only authorized persons can 2. Creation of PC/ device 2. Commissioning of the software read out data from the device, user lists. with additional password. via the interfaces 3. The global security settings 3. The rights of the users for the (RS232, Ethernet) in the Security Manager are programs they are using are provided in the device. configured to customer specification. restricted by the administrator (can be defined in the form of a user profile). Different security levels can be freely set in accordance with customer requirements through configuration of the global security settings and allocation of user rights by the administrator.

6 Fax reply (for fax number see address below) PR GB JUMO LOGOSCREEN es 21 CFR part 11 Compliance Please send me detailed information (Data Sheet ) Sender: Please send me the White Paper (Part No. TN ) Please send me your Product Information LOGOSCREENes (FAS 626) Name Company Address Please send me your: Product Guide (PR GB) Free CD Products Industry Please contact: Name... Phone Fax Phone... Date/time... Date stamp and signature JUMO GmbH & Co. KG JUMO Instrument Co. Ltd. JUMO Process Control, Inc. Street address: JUMO House 8 Technology Boulevard Moltkestraße Temple Bank, Riverway Canastota, NY Fulda, Germany Harlow, Essex CM 20 2TT, UK USA Postal address: Phone: Phone: JUMO Fulda, Germany Fax: JUMO Phone: sales@jumo.co.uk Fax: Fax: Internet: info@jumo.us mail@jumo.net Internet: Internet: /