MES for Pharmaceutical Manufacturing: How to Shorten Batch Review and Reduce Manual Documentation

MES for pharmaceutical manufacturing brings batch execution, equipment data and quality documentation into one controlled process. Operators follow the approved recipe, the system checks materials and process parameters, and QA receives a complete record with exceptions clearly marked. For the business, this can mean fewer manual entries, faster deviation investigations and less time spent reviewing each batch.

This article is written for production directors, quality managers and teams responsible for plant digitalisation. It explains where MES software for pharmaceutical manufacturing supports daily operations, which metrics to collect before the project and how to choose the right scope for the first implementation.

The need for MES rarely starts with a missing dashboard. It is usually visible in the batch record.

In many plants, production data still passes through several stages of manual recording. A weight reading is entered into a form, process parameters are later copied into a spreadsheet, and gaps in the documentation are discovered only during QA review. When a deviation must be investigated, the team also has to collect information from equipment and systems that do not provide one consistent view of the batch.

MES may be worth considering when:

MES connects the production plan with execution on the shop floor. ISA-95 describes this area as the layer between business systems and process control. This is where an order from ERP gains its production context: materials, equipment, operators, parameters, checks and the final execution record.

The first question should therefore be: which activities around a single batch take the most time and create the highest risk of error?

The easiest way to assess MES is to follow one production batch. The steps below show where the system can control the sequence of work and the way data is recorded.

ERP sends the order number, product, quantity and due date. MES assigns the correct recipe and instructions for the selected process variant.

Operators do not need to search through folders or check whether a document is still current. Once the order starts, they see the approved sequence of operations. Version history makes it possible to confirm which parameters and instructions were used for a particular batch.

Before dispensing, the operator scans the material code. MES can verify its identity, batch number, release status, expiry date and required quantity.

If the material does not meet the process rules, the system may block its use or require a decision from an authorised person. At the same time, it records which raw material batch was used in the finished product. This genealogy helps the team define the scope of a deviation, complaint or recall.

The system guides the operator through approved process steps. It may require confirmation of cleaning, equipment status, an in-process control result or an electronic signature.

A block before the next step is useful when an omitted action could affect product quality or the reliability of the batch record. Too many blocks slow down work, so each rule should come from the process and its risk assessment.

Temperature, weight, mixing time, pressure and speed can be sent to MES from a PLC, SCADA system, scale or another device. Each record should include the time, source equipment and connection to the relevant batch and operation.

Older machines do not always prevent integration. The first task is to check available signals, communication options and the reliability of timestamps. When an automatic reading is not possible, a manual field can control the format, acceptable range and required verification.

A value outside its limit can trigger an alert, require a comment or stop the operation. The event becomes part of the batch history together with the user, time and further decision.

Integration with QMS can pass the relevant data to a deviation or CAPA process. The quality team then receives the source information without copying the event description from a production form.

The electronic batch record, or eBR, brings together materials, process parameters, signatures, inspection results, alerts and change history. Review by exception directs QA to out-of-range values, manual entries, communication interruptions and missing confirmations.

An electronic record saves the most time when data is created during execution. A digital copy of a paper form still requires people to enter and verify the same information manually.

Benefits should be connected to data from the plant. Without a baseline, it is difficult to distinguish a better process from a simple change of software.

A simple calculation helps estimate the scale. If QA spends six hours reviewing one batch and the plant closes 40 batches per month, the process uses 240 hours. Reducing review time by two hours would release 80 hours each month.

This is an example calculation, not a performance promise. The real result depends on the process, data quality and the amount of information collected automatically.

This process combines material identification, limits, confirmations and data from scales. MES can guide the operator, verify the raw material and record the result without manual copying.

A pilot is worth considering when documentation corrections often concern weights, batch numbers or material selection.

MES can check packaging materials, artwork versions, line status, counters and line-clearance confirmations. The record links events to a specific order and time range.

Packaging is a good candidate when line data and operator checks are stored separately.

The plant can begin by bringing parameters, alerts, materials and user actions into one view. This can shorten the time needed to reconstruct the process without introducing a full eBR across the entire line.

A pilot should solve a problem that can be measured before and after launch. The number of installed modules is not a useful measure of success.

ERP usually stores orders, products, quantities and material information. MES manages execution. PLC and SCADA systems handle control and process values, LIMS manages samples and laboratory results, and QMS supports deviations, CAPA and change control.

ISA-95 helps define the boundaries and information exchange between business and manufacturing systems.

Each data field needs one source of record. A material release status should not be updated independently in ERP, MES and a spreadsheet. The project also needs clear rules for failures, including local storage, loss of communication, later reconciliation and responsibility for assessing the effect on the batch.

These decisions often require more work than the operator screens.

Regulatory requirements should shape the way the system works, but they should not dominate every discussion about its use.

EU GMP Annex 11 requires a risk-based approach, application validation, infrastructure qualification and controls covering access, changes, audit trails, backup and business continuity. Annex 15 links qualification and validation activities to the system lifecycle and a documented risk assessment.

WHO describes data integrity through the ALCOA+ principles. Records should be attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring and available.

For products supplied to the US market, the company should also assess the scope of 21 CFR Part 11 together with the underlying regulations that require the record.

At the time of publication, EudraLex still lists the January 2011 revision of Annex 11 as the current version. The European Commission published a draft revision in 2025 covering areas such as system lifecycle management, supplier oversight, audit trails, security and electronic signatures. The consultation draft is not yet the binding version of the annex.

For users, every regulatory requirement should lead to a clear system function. An audit trail is useful when QA can see the previous value, the new value, the user, the time and the reason for the change. A checked box in a product specification is not enough.

MES cannot define a process that the company has never described clearly. It will not decide who owns the recipe, which system holds the official data or whether a local exception is still needed.

Projects often underperform when:

Before configuration starts, the team should remove unnecessary steps, assign data owners and define decisions for system or communication failures.

Risk also increases when production, QA, automation and IT do not review the same batch record before writing the requirements.

Choose one process, one batch record and one measurable objective. For example:

These figures illustrate how to define an objective. The values used in a real project must come from the plant.

Review a recently completed batch together with production, quality, automation and IT. Mark every place where data is copied, a decision is delayed or information has to be reconciled manually.

The analysis should produce:

The explitia team implements MES and connects it with ERP, SCADA and other OT and IT systems. The discussion can begin with one batch and its data flow before the company selects a platform or module scope.

MES guides batch execution, checks materials and operating conditions, records process parameters and builds an electronic production history. It can reduce manual entries, identify missing information earlier and shorten batch record review.

No. An electronic batch record can be one part of MES. MES may also cover order execution, recipes, materials, resources, process data and system integrations.

Yes. A pilot on one line or product family allows the company to test integrations, user workflows, metrics and validation scope before extending the system.

Often yes. Data may be collected through PLC, SCADA, OPC or an additional integration layer. The team needs to assess available signals, timestamp accuracy, data reliability and the ability to connect each reading to a specific batch.

Start with one process and one batch record. Measure manual entries, review time, correction rates and the time needed to reconstruct batch history. These figures provide a basis for defining the pilot scope and its acceptance criteria.