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Manufacturing

Manufacturing

Batch Records

Electronic Batch Records

Ensure compliance and improve efficiency by automating your paper-based systems.

The U.S. Food and Drug Administration's (FDA) Current Good Manufacturing Practices (CGMPs) require proof of proper handling for every step of the production process. Batch records and other types of manufacturing documentation demonstrate this level of accountability. Paper-based systems are cumbersome and error-prone. The right electronic batch record (EBR) software system removes the documentation burden from quality and manufacturing teams. It also improves product quality and key performance metrics.

MasterControl Electronic Batch Records™ (EBR)
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Benefits of an EBR System

01

Adhere to regulations easily.

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Under regulations found in 21 CFR Parts 210-211, EBR must demonstrate the accomplishment of every significant step. This includes production, packaging and holding of each batch of a drug product. The right solution helps you meet these requirements and adhere to the FDA’s CGMPs.

02

Track and manage production data.

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Electronic batch records make it simple to track and manage production data. In a paper-based process, it can be difficult to ensure forms are routed to the right place in the correct sequence. EBR software eliminates these problems. It helps maintain data integrity, save time and ensure compliance.

03

Avoid frequent mistakes.

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Paper-based batch records are problematic. Illegible entries and other documentation errors happen too often. Efforts are accidentally duplicated. These and other mistakes can cause significant production delays. It’s time to stop pushing paper. Focus on developing a quality product and getting it to market faster.

04

Operate from a single source of truth.

Manufacturing

With a paper-based system, you can never know with certainty that you are reviewing the most recent batch record. Only one person at a time can review a set of documents. Someone needing to look at those documents must track them down. EBR software makes it possible to store accurate, complete data in one central location. Anyone with permission can access the data at any time from anywhere.

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The Competitive Advantage of Going Paperless

CGMPs require extensive EBR systems documentation. This includes the following:

• Batch dates.

• Identity of major equipment/lines used.

• Components/materials used and their weights and measures.

• In-process and laboratory control results.

• Complete labeling control records.

• Sampling.

• Identification of personnel supervising or checking each step.

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Comply With 21 CFR 210-211

Pharmaceutical companies have traditionally used paper (hard copy) to maintain production batch records. With the advent of 21 CFR Part 11 in 1997, the FDA began to accept EBR systems. When you adopt an EBR system, it must be in compliance with regulations found in 21 CFR Parts 210-211. The requirements include a time-stamped audit trail, reporting, electronic signature and security requirements.

Achieve right-first-time production.

EBR software prevents mistakes from slowing the entire production process.

Download the Product Data Sheet