Electronic Batch Record Systems by Industrial Technology Systems (ITS)

Industrial Technology Systems (ITS) proudly offers Electronic Batch Record Systems (EBRS) designed to revolutionise the way pharmaceutical production facilities manage data.

Our 21 CFR Part 11 compliant EBRS is a cutting-edge solution that replaces cumbersome manual data capture processes with streamlined, efficient electronic record-keeping.

Challenges of Paper-Based Systems

Traditionally, pharmaceutical manufacturers have relied on paper-based systems to painstakingly document operator actions.

These archaic systems pose significant challenges in terms of administration, enforcement, and verification during batch approval and release processes.

The time and effort required for manual data verification can be overwhelming, causing delays in product release and hindering regulatory compliance efforts.

The Advantages of Electronic Batch Record Systems

Recognising the need for a modern and efficient alternative, pharmaceutical manufacturers are increasingly turning to Electronic Batch Record Systems.

ITS has been at the forefront of this digital transformation, delivering substantial benefits to our clients. These benefits include:

  • Increased Productivity: EBRS streamlines data capture, reducing the time and effort needed for documentation. This translates into improved productivity and faster manufacturing processes.

  • Reduced Time to Market: With faster data processing and approval, pharmaceutical companies can bring their products to market more swiftly, gaining a competitive edge.

  • Enhanced Regulatory Compliance: ITS EBRS solutions are fully compliant with 21 CFR Part 11, the FDA's stringent rule for electronic records and signatures. This ensures that our systems meet the highest standards for data integrity and regulatory compliance.

Success Stories

The customer's system was upgraded by ITS with the addition of a batch control system, capable of automatically controlling the plant by means of Unit Operations. The new system had to function in accordance with the principles of the ISA-88 batch control standard.

ITS Electronic Batch Record Systems Features

ITS specialises in designing and implementing EBRS systems using standard off-the-shelf products, ensuring cost-effective and scalable solutions.

Our systems offer secure access through web browsers, and data capture devices efficiently record critical data.

The system is designed to automatically create and control electronic forms for various activities, including:

  • Work order creation

  • Component dispensing

  • Line clearance

  • Component collection

  • Production interventions

  • Production output

  • Product quality sampling

  • End-of-batch checks

  • Return to stock

  • Waste calculations

  • Product handover and packing

Benefits of ITS EBRS Reports

One of the most significant advantages of ITS EBRS is the speed and efficiency it brings to the batch approval and release processes.

Our system generates comprehensive batch reports that enable pharmaceutical manufacturers to complete these critical tasks in a fraction of the time required by manual processes.

This not only reduces the elapsed time between product creation and approved release but also results in substantial cost savings associated with work in progress.

How ITS can help?

ITS Electronic Batch Record Systems are a game-changer for the pharmaceutical sector.

By embracing our state-of-the-art EBRS, manufacturers can significantly reduce product time-to-market, enhance productivity, and ensure compliance with FDA/MHRA regulations.

With ITS, you have a trusted partner dedicated to improving your operational efficiency and regulatory adherence in the pharmaceutical industry.