Aczet 21 CFR Part 11 Compliance Software – Secure Data Management for Regulated Laboratories

In regulated industries such as pharmaceuticals, biotechnology, and food manufacturing, maintaining FDA-compliant electronic records is not just a best practice—it’s a legal requirement. The Aczet 21 CFR Part 11 PC Software is a validated, audit-ready solution designed to ensure full compliance with FDA 21 CFR Part 11 regulations for electronic records and signatures (ERES). Integrated seamlessly with Aczet CM/CY Series Laboratory Balances, this software provides secure, traceable, and tamper-proof data management for precision weighing applications.

Key Features & Benefits

1.) Full Compliance with FDA 21 CFR Part 11

• Electronic Signatures (ESIG) – Ensures authorized personnel authentication with unique user credentials (username, password, or biometric options).
• Audit Trail Functionality – Automatically logs all balance interactions, including:

1. User logins/logouts
2. Calibration changes
3. Weight measurements
4. Data modifications or deletions

• Data Integrity Protection – Prevents unauthorized alterations with encrypted storage and read-only archived records.

2.) Secure & Centralized Data Management

• Real-Time Data Capture – Directly transfers weight measurements from Aczet CM/CY balances to a secure database.
• Cloud & Local Storage Options – Supports SQL databases, network storage, or FDA-compliant cloud solutions.
• Custom Report Generation – Exports data in PDF, CSV, or XML formats for regulatory submissions.

3.) User Access & Permission Controls

• Role-Based Access (RBAT) – Assigns different permission levels (e.g., Operator, Supervisor, Administrator).
• Two-Factor Authentication (2FA) – Optional SMS or email verification for high-security environments.

4.) Integration with Aczet Laboratory Balances

• Plug-and-Play Compatibility – Works seamlessly with Aczet CM/CY Series Analytical & Precision Balances.
• Automated Calibration Logs – Records all calibration events with time stamps and user IDs.

5.) Audit-Ready Documentation

• Pre-Configured Compliance Templates – Ready-to-use SOPs (Standard Operating Procedures) for FDA audits.
• Electronic Batch Records (EBR) – Supports GMP/GLP workflows with batch-wise data tracking.

Technical Specifications

Applications of Aczet 21 CFR Part 11 Compliance Software

1.) Pharmaceutical Manufacturing

• Ensures batch traceability for raw material weighing.
• Complies with FDA & EU GMP for drug formulation.

2.) Biotechnology & Life Sciences

• Maintains data integrity for research documentation.
• Prevents data falsification in clinical trials.

3.) Food & Beverage Industry

• Tracks ingredient measurements for quality control.
• Meets FSMA (Food Safety Modernization Act) requirements.

4.) Chemical & Petrochemical Labs

• Secures hazardous material records for compliance.
• Prevents unauthorized access to sensitive data.

Why Choose Aczet 21 CFR Part 11 Software?

• Trusted by Regulated Industries – Aczet balances and software are used in FDA, WHO-GMP, and ISO 17025-certified labs.
• Seamless Integration – No complex setup; works instantly with Aczet balances.
• Future-Proof Compliance – Regular updates to meet evolving regulations.
• Dedicated Support – Includes validation documentation (IQ/OQ/PQ) for easy audits.

Why Choose UP Scales?

UP Scales is a trusted name in the weighing industry, known for delivering high-quality, reliable, and accurate weighing solutions. Here’s why professionals prefer UP Scales:

• Government Calibration Verification Certificate: Our balances come with a Government Calibration Verification Certificate and stamping by the Legal Metrology Department, ensuring compliance with legal standards.
• 1-Year On-Site Warranty: We offer a 1-year on-site warranty, ensuring prompt technical support and maintenance.
• Same-Day Free Delivery & Installation: Enjoy same-day free delivery and installation services in Delhi NCR, minimizing downtime and getting your operations up and running quickly.
• Expert Customer Support: Our team is always ready to assist you with any queries or technical issues. Call us at 9899008683 for immediate support.

Government Calibration and Free Delivery (Limited Area):

UP Scales offers optional Government Calibration Verification Certificates and NABL Certificates for an additional fee. We also provide free delivery and installation for customers in Noida, Greater Noida, Delhi and Ghaziabad.

Safety First - COVID-19 Compliant Deliveries:

Our delivery and installation engineers strictly adhere to all COVID-19 safety guidelines established by the Indian Health Ministry and the World Health Organization.

Contact UP Scales Today:

For a free quote, brochure, or to discuss your specific weighing needs, contact UP Scales today! We offer a 1-year on-site warranty.