21CFR, Fette America

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Fette tablet presses are equipped with an operator interface terminal, running on a Bernecker and Rainer (B&R) 5000 Pentium computer. They are equipped with control software written by Fette's software development department located at our facility in Schwarzenbeck, Germany. While our system complies with most of the regulations set forth in 21CFR Part 11, we have assembled an action plan to enable us to achieve full compliance

by the end of 2002. The plan includes a complete review of the regulation itself, a review of our control system software and the procurement of the services of an American based consulting firm specializing in computer based systems validation and 21CFR Part 11. The following lists the specific requirements set forth in "Good Practice and Compliance for Electronic Records and Signatures, Part 2 Complying with 21 CFR Part 11 Electronic Records and Electronic Signature - A Document produced jointly by ISPE and PDA" and our assessment of the current system's capabilities and compliance status, plus the steps we will take to achieve full compliance by the end of 2002. Each section has been addressed individually, including our plans for compliance. 11.10 (a) Electronic Record/Electronic Signature (ER/ES) system should be able to identify changes to electronic records in order to detect invalid or altered records. In practice, this means having an adequate audit trail that can be searched for information. For example, to determine whether any changes have been made without the appropriate authorization. Access to controlled files is controlled from the operating system security, not accessible to the customer. Corrupted data files cannot be imported. Altered data files will not overwrite existing data files. A change log tracks system changes through normal channels. 11.10 (b) ER/ES systems should allow applicable electronic data to be accessed in human readable form. ER/ES systems need the ability to electronically export applicable data and any associated data (e.g. audit trails, configuration information relating to identification and status of users and equipment). All data can be read on the screen or printed in a human readable form. Electronic data, production reports, change reports, alarm (diagnosis) reports and machine set-up profiles can be exported. Importing these records will not overwrite the exported data. 11.10 (c) ER/ES systems should be able to maintain applicable electronic data (including any associated data, e.g. audit trails configuration information relating to identification and status of users and equipment) over periods of many years, regardless of upgrades to the software and operating environment, and should be able to export such data electronically and in human readable form. Fette maintains a repository of all source and executable software for all versions of software, plus a recovery procedure to re-install the system back to the factory settings (for application data). 11.10 (d) ER/ES systems should restrict access in accordance with pre-configured rules that can be maintained. Any changes to the rules should be recorded. The software has a password and user identification (ID) system. Additionally, features of the software can be assigned to different security levels. The change of a user ID's level of access is not recorded in the audit trail. Audit trails can be exported and maintained by super-user accounts. 11.10 (e) ER/ES systems should be capable of recording all electronic record create, update and delete operations. Updates should not obscure previous value. Data to be recorded must include, as a minimum: time and date, unambiguous description of event and identity of the operator.

This record should be secure from subsequent, unauthorized alteration. Audit trails must be available in human readable form and able to be exported in both hard copy and electronic copy. Audit trail captures alarms, parameter changes, batch starts and stops, and whether a batch has been deleted, among other processes. These records are secure from unauthorized alteration and can be exported on paper and electronically. All audit actions include a time and date stamp. The audit trail captures when the operator logs in and logs out. All actions between that time and attributable to the operator, even though the operator's user ID is not listed with each record in the audit trail. 11.10 (f) Where operations are required in a pre-defined order for example in batch manufacture, the ER/ES system should enforce that ordering through the system's design. The Fette software operates the machinery in a logical sequence of operation, but this operation is invisible to the user and cannot be changed through normal configuration channels. 11.10 (g) ER/ES systems should restrict use of system functions and features in accordance with configurable rules that can be maintained. Any changes to the rules should be recorded. The software has a password and user ID system. Additionally, features of the software can be assigned to different security levels. Changes to the access level of features are currently not captured, but will be captured in a future modification. 11.10 (h) Where pharmaceutical organization requires that certain devices act as sources of data or commands, the ER/ES system should enforce the requirement. The Fette software is a closed system, as defined by 21CFR Part11 and obtains inputs from the control devices and user input. All data is checked for validity (and verified under the software validation). 11.10 (i) Supplier requires procedure to demonstrate that persons who develop and maintain electronic record/electronic signature systems have the education, training and experience to perform their assigned tasks. Fette has procedures in place related to ISO9001 systems that assure only qualified individuals have access to the software development. Resumes of persons working with the software development are available on request. 11.10 (j) Policy needed to describe the significance of electronic signatures, in terms of individual responsibility, and the consequences of falsification both for the pharmaceutical organization and for the individual. It is the responsibility of the pharmaceutical customer to procedurally define the significance of the electronic record. 11.10 (k) Where systems documentation is in electronic form and can be changed by the pharmaceutical organization, an electronic audit trail should be maintained, in accordance with 11.10 (e) above. Once pharmaceutical documentation is turned over to the customer (and the customer can elect to receive electronic files), the customer is responsible for the maintenance and procedural control of those files. 11.50 ER/ES systems must ensure signed electronic records contain information associated with the signing that clearly indicates all of the following: The printed name of the signer; The date and time when the signature was executed and; The meaning (such as review, approval, responsibility or authorship) associated with the signature.

These items are subject to the same controls as other electronic records. The information can be stored within the electronic record or in logically associated records, but must always be shown whenever the record is displayed/printed. Fette software maintains a user ID associated with all electronic records. It is the responsibility of the customer to maintain a reference of user IDs to the signers' names. It is possible to print a partial batch record to exclude the user ID, but the user ID of the person who printed the report is captured in the audit trail. All electronic records have a date and time stamp (from the PC clock). The change of the time and date is recorded in the audit trail. The activities the operators make using the Fette software should be qualified by the customer as to the level ownership the operator is assuming. 11.70 ER/ES systems must provide a method for linking electronic signatures and handwritten signatures, where used, to their respective electronic records, in a way that prevents the signature from being removed, copied or changed to falsify that or any other record. Electronic signatures cannot be falsified because they cannot be removed, copied, or re-applied. 11.100 (a) ER/ES system should enforce uniqueness, prevent re-allocation of electronic signature and prevent deletion of information relating to the electronic signature once it has been used. Electronic user IDs are unique. Duplicate user IDs cannot be used. People who have the same name must use different user IDs. A system administrator cannot view passwords for others, but can otherwise maintain user accounts. 11.200 (a) (1) ER/ES systems providing non-biometric electronic signatures need at least two distinct components. Pharmaceutical organization needs to establish how it will ensure that both components of electronic signature are entered if the session has not been continuous. ER/ES system should enforce that both components are entered at least at the first signing and following a break in the session. The user IDs in Fette software, contain a unique user ID and password. In order for an electronic record to be generated the user must be logged in, and that necessitates both the user ID and password. Future software versions will prohibit the operator from leaving the machine or for automatically logging the user out. 11.200 (a) (3) ER/ES system should not provide any ordinary means of accessing electronic signature (e.g. passwords). The customer is responsible for procedures to keep passwords secret. The Fette software encrypts the passwords and does not allow passwords to be viewed through any ordinary means. 11.300 (b) System should force passwords to be periodically changed and also enable ID/password combinations to be rendered inactive without losing the record of their historical use. It is recognized that this may not be possible, e.g. for certain embedded or PLC systems, in which case use procedural controls. The pharmaceutical customer must ensure that procedures are in place for password maintenance. The Fette software does not force periodic password changing. It is expected that this feature will be available in the future. 11.300 (d) System should provide notification of attempted unauthorized

access and should take preventative measures (e.g. lock a terminal after a specified number of failed attempts, retain card). Future versions of the Fette software will link the password methods to the NT operating system, which will allow for the same aspects of the NT password authority. This will allow for use of security logs, recording of unauthorized attempts, and response to security breach attempts. Return to Menu