|
Batch Records System and Device History Records
 Electronic Batch Records (EBR) System for pharmaceutical companies and Device History Records (DHR) for medical device companies are included in the Quality Management module. The EBR system can easily integrate with your CAPA, nonconformance, deviations or other quality process. The quality processes are connected within the system and reports and/or trend alerts can be set so managers are never out of touch with their quality and regulatory systems.
Moving to an electronic system automates the routing, notification, escalation, and approval for your batch records. It also provides a centralized repository for all EBR related documentation that makes search and retrieval easy.
Quality Manager’s configurable forms tool allows for the easy creation of a form to meet each company’s specific needs. Some of the fields available include batch dates, identity of major equipment/lines used, components/materials used and their weights, in-process and laboratory control results, complete labeling control records, sampling, and identification of personnel supervising or checking each step.
 The task manager automates task assignment and follow-up via automatic e-mail notification. Tasks are automatically sent via email to Outlook or other email systems, so users do not need to be logged into the system to be up to date on their workload. Any recurring EBR-related activities can be included in a task profile, however users have the option to add tasks on an ad-hoc basis to individual EBR events. Quality Manager incorporates escalation capability for any task not completed by deadline.
|
Title21 Software’s Batch Records:
• Meets 21 CFR Part 11 requirements with a signature manifestation that includes name, date, time, and meaning of electronic signature (reviewed, approved, rejected, etc.)
• Decreases time spent tracking down pieces of information; a central repository allows for easy search and retrieval
• Allows companies to become virtually paperless
• Is part of the Quality Manager Module, so other quality events such as equipment calibration, complaints, CAPAs are linked to ensure compliance with FDA regulations and ISO quality standards
• Integrates with the Document Control and Training Modules to create a “Closed Loop” Quality Management Solution
|
Some of the reports available include:
EBR Summary: Gives a top level view of all the EBRs in the system, categorized by owner and department.
EBR Detail: Includes batch dates, identity of major equipment/lines used, components/materials used, electronic signatures.
EBR by Owner: Lists EBRs categorized by owner within specific date ranges.
Open EBR: Lists open EBRs categorized by department.
|
|
