MES/EBR | Migrating from Paper to Electronic | Malcom Associates
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Migrating from Paper to Electronic (EBR/MES)

EBR/MES benefits will not be fully realized until you ‘simplify and lean the existing paper Batch Record documentation and data workflow FIRST’.

When simplifying and leaning the documentation and workflow first, the question “Are you ready for EBR/MES deployment?” can be answered and financially justified.

In accordance with FDA, paper-and-ink based and electronic data record-keeping systems are subject to the same requirements:

  • § 211.68 requires that backup data are exact and complete, and secure from alteration, inadvertent erasures, or loss
  • § 212.110(b) requires that data be stored to prevent deterioration or loss
  • § 211.100 and § 211.160 require that certain activities be documented at the time of performance and that laboratory controls be scientifically sound
  • § 211.180 requires true copies or other accurate reproductions of the original records; and
  • § 211.188, § 211.194, and § 212.60(g) require complete information, complete data derived from all tests, complete record of all data, and complete records of all tests performed

A workflow, such as creation of an electronic master production and control record (MPCR), is an intended use of a computer system to be checked through validation (see § 211.63, § 211.68(b), and § 211.110(a)).

If you validate the computer system, but you do not validate it for its intended use, you cannot know if your workflow runs correctly.  For example, qualifying the Manufacturing Execution System (MES) platform, a computer system, ensures that it meets specifications; however, it does not demonstrate that a given MPCR generated by the MES contains the correct calculations.  In this example, validating the workflow ensures that the intended steps, specifications, and calculations in the MPCR are accurate.

This is similar to reviewing a paper MPCR and ensuring all supporting procedures are in place before the MPCR is implemented in production (see § 211.100, § 211.186, and § 212.50(b), and the guidance for industry PET Drugs — Current Good Manufacturing Practice (CGMP)) 1.

What We Do

We perform a comprehensive assessment of the batch record transactions, workflow, equipment capabilities, in-process testing frequencies, and data collected.  We also assess interfaces with current and future systems to confirm and/or invalidate EBR/MES requirements.

This assessment can be conducted (recommended) as part of a batch record simplification and leaning initiative to identify where opportunities for improvement are needed before EBR/MES deployment.  This results in reduced implementation time and costs.

The assessment defines the necessary work instructions, data and signature transactions to meet regulatory and process control requirements.  Elements of the assessment:

  • Group steps into logical unit operations to minimize the number of system transactions
  • Justifies all data requirements and consolidation of data to eliminate redundancy and unnecessary transactions
  • Defines data sources, review and verify “validated” parameter values and acceptable ranges
  • Defines guidelines for what is required to be documented/captured to meet cGMP regulatory compliance
  • Confirm and/or recommend changes to user and functional requirement specifications
  • Identify what data to integrate to EBR/MES
  • Revisions and development of SOPs to support and comply with system functionality and interfaces

( 1 Data Integrity and Compliance With CGMP Guidance for Industry, April, 2016)

Contact Us to learn more about our paper to electronic migration expertise.