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Professional Services Consulting Onboarding Services. Events Upcoming. Webinar Recordings. Experts Talk Sessions. Announcing codebeamer Try Now. System Maintenance! Data Backup, Recovery, and Contingency Plans! Change Control. If the name displayed by the screen during a data entry session is not that of the person entering the data, then that individual should log on under his or her own name before continuing.
The ability to change the date or time should be limited to authorized personnel and such personnel should be notified if a system date or time discrepancy is detected. Changes to date or time should be documented. Dates and times are to be local to the activity being documented and should include the year, month, day, hour, and minute. The Agency encourages establishments to synchronize systems to the date and time provided by trusted third parties. Clinical study computerized systems will likely be used in multi-center trials, perhaps located in different time zones.
Calculation of the local time stamp may be derived in such cases from a remote server located in a different time zone. Prompts, flags, or other help features within the computerized system should be used to encourage consistent use of clinical terminology and to alert the user to data that are out of acceptable range. Features that automatically enter data into a field when that field is bypassed should not be used.
Electronic patient diaries and e-CRFs should be designed to allow users to make annotations. Annotations add to data quality by allowing ad hoc information to be captured. This information may be valuable in the event of an adverse reaction or unexpected result. The record should clearly indicate who recorded the annotations and when date and time. Recognizing that computer products may be discontinued or supplanted by newer possibly incompatible systems, it is nonetheless vital that sponsors retain the ability to retrieve and review the data recorded by the older systems.
This may be achieved by maintaining support for the older systems or transcribing data to the newer systems. When migrating to newer systems, it is important to generate accurate and complete copies of study data and collateral information relevant to data integrity.
This information would include, for example, audit trails and computational methods used to derive the data. Any data retrieval software, script, or query logic used for the purpose of manipulating, querying, or extracting data for report generating purposes should be documented and maintained for the life of the report. The transcription process needs to be validated. FDA expects to be able to reconstruct a study. This applies not only to the data, but also how the data were obtained or managed.
Therefore, all versions of application software, operating systems, and software development tools involved in processing of data or records should be available as long as data or records associated with these versions are required to be retained. Sponsors may retain these themselves or may contract for the vendors to retain the ability to run but not necessarily support the software.
Although FDA expects sponsors or vendors to retain the ability to run older versions of software, the agency acknowledges that, in some cases, it will be difficult for sponsors and vendors to run older computerized systems. In addition to internal safeguards built into the system, external safeguards should be in place to ensure that access to the computerized system and to the data is restricted to authorized personnel.
Staff should be thoroughly aware of system security measures and the importance of limiting access to authorized personnel. Access to the data at the clinical site should be restricted and monitored through the system's software with its required log-on, security procedures, and audit trail. The data should not be altered, browsed, queried, or reported via external software applications that do not enter through the protective system software.
There should be a cumulative record that indicates, for any point in time, the names of authorized personnel, their titles, and a description of their access privileges. The record should be in the study documentation accessible at the site. If a sponsor supplies computerized systems exclusively for clinical trials, the systems should remain dedicated to the purpose for which they were intended and validated. If a computerized system being used for the clinical study is part of a system normally used for other purposes, efforts should be made to ensure that the study software is logically and physically isolated as necessary to preclude unintended interaction with non-study software.
If any of the software programs are changed the system should be evaluated to determine the effect of the changes on logical security. Controls should be in place to prevent, detect, and mitigate effects of computer viruses on study data and software.
The sponsor should ensure and document that computerized systems conform to the sponsor's established requirements for completeness, accuracy, reliability, and consistent intended performance. Good Guidance Practices. Enter your email address to subscribe:. Signed documents must be easily accessible to those with a valid need to use them.
Electronically signed documents must also be stored securely so there is no risk of corruption of the signature or the data contained within. The Code of Federal Regulations is very user-friendly and easy to understand. For more information, or to read these regulations in their entirety, users can visit the FDA's website online.
The text of 21 CFR Part 11 is located within this site. The regulations are easily organized with clickable links, and allow users to print or bookmark sections for later use. Arbour Group has provided us with competent validation project leadership that has enabled us to complete projects in a timely and cost effective manner. The regulatory assistance provided by Arbour Group has enabled us to enhance our compliance profile with life sciences customers. Their Managed Services for software development and quality assurance play a key role in controlling business risk and reducing costs.
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