Electronic Batch Control with Title 21 CFR Part 11 Compliance Software
Electronic Batch Records
In industries with stringent regulations, our V5 Electronic Batch Record System guarantees precise ingredient measurements and tracing. This avoids expensive excesses and batches that don’t meet specifications. Brochure
The system sets strict tolerances for each ingredient, depicted through a green speedometer-style target zone. A recipe cannot be completed unless all ingredients align within these tolerances.
Efficiently scanning and validating lot numbers, the system offers real-time inventory tracking, thereby eliminating the need for expensive traceability documentation. For integration with ERP, refer to our ERP Page
The system provides an EBR (Electronic_Batch_Record), complete with a digital review process and sign-off mechanism, adhering to with 21 CFR Part 11 standards. Our data security aligns with the ALCOA principles and fulfills GMP standards. SG Systems offers the necessary IQ/OQ documentation support.
Intuitive Batching Display
Our user-friendly interface lets management efficiently schedule production tasks (or directly import from ERP) across one or multiple specialized batching terminals.
Every ingredient step comes with distinct requirements (whether weighed, entered manually, counted, managed in bulk, etc.). Additionally, ingredients can be measured in horizontal (campaign) or vertical (batch) configurations, either sequentially or non-sequentially.
Personalized operator logins grant different access and control degrees, meticulously documenting all operations. This can be a local login or utilizing Active Directory.
Safety Protocols, SOPs & QA
Targeted notifications guide operators in complying with requirements, including Allergens, Safety Directives, HACCP, and SOPs.
Integrate the most recent GHS Safety & Allergen Icons to consistently present to operators when needed.
Design a tailored repository of quality assurance queries and responses, catering to the mandates of HACCP, COSHH, SOPs, GMP, and other safety and quality guidelines.
The system chronicles answers to batch-related queries, enabling a digital-first QA approach.
Ingredient / Batch Labels
Many label printing options exist to identify Ingredient / Batch printing applications. (Click here for finished product label printing).
Standard Label Fields
Job & Batch Number, Recipe Code, Recipe Description, Operator Code & Name, Produced Date & Time, Batch Expiration, Mix Size, Batch Size, Bag Number, Weigh, Container Count.
Labeling Events (events which generate labels)
Ingredient weigh, lot change, batch end, container change, separate ingredients, non-weighed items, suspended / aborted batch.
V5 Formula Control Scale System
Device Specifications
The SG15 Touch Panel is a IP69K robust industrial PC tailored for challenging production environments. Typically, it comes with a stainless steel stand and an integrated scale. However, it can also interface with various scales and balances through its inbuilt connectors.
This device boasts compression seals to enhance ingress defense. Cable insertions are both sealed and safeguarded.
These terminals come preloaded with software programs that operate on either Windows or Linux as the underlying OS.
The stainless steel holders, weighing systems, and printer casings are meticulously welded and finished to top-tier manufacturing criteria.
Supported Devices:
Weighing Tools (2 x serial RS232 ports).
Barcode Scanners (direct USB or Bluetooth)
Label & RFID Printers (via network)
Reporting Printers (networked)
Temp Sensors (serial RS232)
PLC & control gear (serial/network connections)
Connectivity
These panels employ TCP/IP protocols, connecting to databases over a wired or wireless LAN. This setup enables several terminals to liaise with a primary database. Terminal maintenance is achieved via VNC or RDC.
V5 Traceability makes digital batch records and compliance with 21 CFR Part 11 considerably easier
George Dust, Life Plus
Pharmaceutical Recipe Formulation
The V5 Traceability system by SG Systems is a comprehensive Electronic Batch Record (EBR) solution designed for the pharmaceutical industry to meet strict regulatory compliance requirements. It guarantees accurate ingredient measurements and traceability, avoiding excesses and non-conforming batches by setting precise tolerances. The system features an intuitive batching display with a user-friendly interface for efficient production task scheduling and management, ensuring that every step of ingredient processing meets specified requirements. Safety protocols and quality assurance are embedded into the system, guiding operators through allergen management, HACCP, and SOPs compliance.
In addition to facilitating compliance with Title 21 CFR Part 11, the system supports personalized operator logins, providing different levels of access and control while meticulously documenting all operations. The SG15 Touch Panel, an integral part of the system, is built to withstand challenging production environments and comes preloaded with software compatible with both Windows and Linux operating systems.
Label printing options are varied, catering to different requirements for identifying ingredients and batches. The system’s connectivity protocols allow for seamless integration with other manufacturing equipment and real-time data tracking, which is crucial for maintaining competitive and profitable pharmaceutical manufacturing operations.
Overall, the V5 Traceability system enhances operational efficiency by reducing human error, improving batch consistency, and ensuring GMP compliance. It represents a significant shift from manual to electronic batch records, streamlining pharmaceutical manufacturing processes and improving the quality control, data integrity, and overall efficiency of manufacturing operations.
Pharmaceutical Formulation FAQ’s
What is the V5 Electronic Batch Record System? The V5 EBR system is a specialized digital tool for pharmaceutical manufacturing, ensuring precise ingredient tracking and compliance with regulatory standards like 21 CFR Part 11.
How do EBRs like V5 Traceability improve pharmaceutical manufacturing? EBRs like V5 Traceability streamline batch recording, enhance accuracy, reduce manual errors, and ensure regulatory compliance, significantly improving overall manufacturing efficiency.
What regulatory standards are addressed by V5 Traceability EBR? V5 Traceability complies with 21 CFR Part 11 and other GMP standards, ensuring data integrity and secure, compliant manufacturing processes.
What’s the difference between traditional Batch Manufacturing Records (BMR) and V5 EBRs? Unlike manual BMRs, V5 EBRs automate the documentation process, reducing errors and streamlining production, making them more efficient and reliable.
How does V5 Traceability manage variability in drug manufacturing? V5 Traceability adapts to different manufacturing conditions and processes, efficiently handling the high variability and dynamic nature of pharmaceutical manufacturing.
What are the benefits of using V5 Traceability in pharmaceutical manufacturing? V5 Traceability reduces human error, enhances batch consistency, improves GMP compliance, and increases overall operational efficiency in pharmaceutical manufacturing.
Can V5 Traceability integrate with existing manufacturing equipment? Yes, V5 Traceability is designed to integrate seamlessly with a variety of manufacturing equipment, enhancing operational efficiency and data accuracy.
What training is required for effective use of the V5 Traceability EBR system? Training for V5 Traceability involves understanding its software interface, compliance requirements, and functionalities specific to pharmaceutical manufacturing.
How does the V5 Traceability system contribute to environmental sustainability? By digitizing records, V5 Traceability reduces paper use, contributing to more sustainable manufacturing practices.
What is the future outlook for EBR technology like V5 Traceability? The future of EBR technology, including V5 Traceability, is promising due to its operational efficiency, compliance benefits, and adaptability to various manufacturing needs.
What challenges do manual batch record processes pose? Manual batch processes, often slow and error-prone, face challenges in efficiency, accuracy, and compliance, which are addressed by EBR systems like V5 Traceability.
How do EBR solutions like V5 Traceability address inefficiencies in manual processes? V5 Traceability and similar EBR solutions offer real-time validation and automated workflows, significantly improving process efficiency and reducing manual errors.
Why is data tracking important in pharmaceutical manufacturing? Efficient data tracking, crucial for competitive and profitable manufacturing, is facilitated by EBR systems like V5 Traceability, enabling real-time data collection and analysis.
How do EBR systems like V5 Traceability enhance data tracking and quality control? V5 Traceability improves data tracking and enables prompt quality event identification and corrective actions, crucial in pharmaceutical manufacturing.
What problems arise from disconnected systems in batch record management? Disconnected systems hinder collaboration and efficiency. EBR systems like V5 Traceability ensure seamless integration and communication between different manufacturing processes.
How does V5 Traceability handle the dynamic nature of pharmaceutical manufacturing? V5 Traceability is designed to be flexible and adaptable, efficiently managing the variability and complexities inherent in pharmaceutical production.
What are the key advantages of EBR solutions over traditional systems? EBR solutions like V5 Traceability offer greater flexibility, error reduction, and adaptability, particularly in environments with high variability like pharmaceutical manufacturing.
How does V5 Traceability impact the overall efficiency of manufacturing processes? By automating and streamlining batch records, V5 Traceability enhances the overall efficiency, collaboration, and compliance of manufacturing processes.
Why is shifting from manual to EBR systems like V5 Traceability essential? Transitioning to EBR systems like V5 Traceability is critical for modern manufacturing efficiency, data integrity, and compliance with regulatory standards.
What overall impact do EBRs have on pharmaceutical manufacturing operations? EBRs like V5 Traceability revolutionize manufacturing operations by improving documentation accuracy, ensuring compliance, and enhancing operational efficiency and quality control.
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