Electronic Batch Manufacturing records and MES in Pharmaceutical

A white Paper on the adaption of eBMR and MES in the Pharmaceutical Industry

1. Base eBMR
BASE INFORMATION MANAGEMENT PVT. LTD.
ELECTRONIC BATCH MANUFACTURING RECORD

2. CHAPTER 1
eBMR
Overview
and
Business Strategy
Metis eBMR automates the batch manu-
facturing record(BMR). The software
runs on an iPad or an Android device,
digitizes the BMR, eliminates the need to
use paper records.
The concept used in eBMR is ‘paper on
glass’. Since it reproduces the interactiv-
ity of a paper based BMR on the digital
platform, it makes the transition to the
eBMR platform easy.

3. EBMR - OVERVIEW
1.What is eBMR
2.The Landscape
3.Process flow
4.Benefits of eBMR
SECTION 1
Overview
SECTION 1.1
What is eBMR
Before we understand an eBMR, lets understand a BMR. BMR
is a paper document which is used in the manufacturing floor
to capture the complete record of the process carried out for a
batch.
A BMR template is created for each product, which defines
the way manufacturing is to performed.
BMR Template encapsulates
•A step by step instructions to the operator to perform
the step
•An empty space to capture the observation of the opera-
tor while performing the manufacturing task.
The template is used for product throughout the manufactur-
ing process by the operator as a guideline to perform the
steps. The process parameters and observations during the
process are recorded.
The eBMR is essential in simple terms digitization of the BMR
document. If you talk in simple terms, you can call scanning
of the paper copy and store it in a standard document manage-
ment system(DMS) to store, retrieve and archive the paper
copy in digital format. Though as a definition it sounds true
and logical, in the current context we are talking about eBMR
2

4. is not just scanning of the BMR. The eBMR is to define, cap-
ture, store and archive BMR information in intelligent man-
ner. Naturally the entire lifecycle of eBMR is executed in a digi-
tal device, like PC, laptop or a tablet.
eBMR provides an intelligent and interactive way
•Author and Define the BMR template
•Step by step instructions to the operator to perform the
task
•Realtime recording of observations and process parame-
ters by the operator during manufacturing process
•System provides intelligent alerts of exception while
the manufacturing execution is going on.
•Review of eBMR on digital format with exceptions high-
lighted.
•Integrate with manufacturing machines to pull out in-
formation and push operating set up and instruction in
realtime
•Store, Achieve, Retrieve and Retire BMR information
in digital form
SECTION 1.2
The Landscape
As indicated earlier, eBMR co-exists in a digital environment
along with many other software. It needs to interact and inte-
grates with other softwares in order to deliver the value.
It integrates with ERP, LIMS, QMS, MES and individual
equipments or machines.
SECTION 1.3
Process flow
A broad level process flow involves 4 areas, design the tem-
plate, define the batch detail, execute and Confirm the eBMR.
3
Events/Exceptions
Process Parameters
BOM/Process
INTERACTIVE 1.1 eBMR Software Landscape

5. Broadly the process flow involves
•Design the template
•Execute the eBMR
•Review eBMR
•Confirm the eBMR
Design the Template
For each product a eBMR template is to be designed. The template
like the paper based template defines the way the manufacturing
has to be carried. It also defines the inputs that are to be captured
and calculations involved.
Execute the eBMR
When the manufacturing has to be done for the product, the batch
information is defined in the ERP. The release process of eBMR
pulls out information from the ERP and Template; creating an exe-
cution template.
For each process the template is filled by the operator during the
execution of manufacturing. This information is simultaneously is
checked by the quality assurance (QA). On completion of the proc-
ess, review can be done by the reviewer.
Confirm the eBMR
Once the manufacturing process is over, eBMR is confirmed
4
eBMR Template Design
Release eBMR
Define the Work Order
For Each Process
Execute eBMR Check eBMR
Confirm eBMR
Review eBMR
Dispense RM

6. SECTION 1.4
Benefits of eBMR
The advantages of an eEBR system can be grouped into two
categories:
Operational efficiency
Compliance improvements.
★Operation Benefits
•Reduced cycle times – reductions in the physical pass-
ing of records between departments will lead to an over-
all reduction in the time needed to produce and ship
product.
•Improved accuracy and consistency of batch record –
Highlight the errors in batch record, which in turn will
decrease the time spent by quality assurance in the re-
view of these records.
•Reduced costs of compliance – automation of quality as-
surance functions and reporting features in the software
will decrease the effort required to spot product devia-
tions.
•Increased productivity – electronic exchange of batch
records decreases the amount of time spent collecting
the various components of the batch record from differ-
ent departments. The review process can start even be-
fore the batch is completed
•Cost avoidance – batch records must be retained for at
least one year after the expiration of product. Use of elec-
tronic batch records can eliminate the need to allocate
resources to the storage and retrieval of archived batch
records.
★Compliance Benefits
•Error reduction in documentation
•Enforce data entry and sequencing
•Provide immediate user feedback to adverse results
•Eliminate calculation errors
•More effective review
•Eliminate redundant verifications
•Review by exception-exceptions are highlighted
•Documentation requirements
•Improve the demonstration of compliance
5

7. DEFINE THE EBMR STRATEGY
1.Define the scope and objective of the eBMR
project
2.Define the integration strategy
3.Plan out the infrastructure
4.Define the testing and validation strategy
5.Manage the transitions
6.Prioritize the products which are to be
digitized.
SECTION 2
Strategy
Define the eBMR Strategy
For a successful eBMR implementation, it is important to de-
fine the eBMR strategy. Below is a methodology for the same
1) Define the scope and objective of the eBMR project
eBMR as a term can range from standard ERP manufacturing
functionality to fully automated Manufacturing Execution So-
lution(MES). Depending upon the business objective and the
level of digital enabled equipments availability, the scope
should be defined to what extent automation is to be done.
A typical eBMR landscape in the context of manufacturing en-
vironment
Since it involves transition of way of physical working in shop
floor, progressive and phase wise implementation is always
simple and effective.
Within the eBMR functionality itself there are many enhance-
ment can be done to the the product BMR to take advantage
of the digital platform.
2) Define the integration strategy
The eBMR as a solution requires integration with other soft-
ware like ERP, Quality Management Systems (QMS), Labora-
tory Management System(LIMS), Manufacturing Execution
System (MES) and the manufacturing machines. Depending
on the landscape in which the eBMR to be implemented the
integration strategy has to defined.
6

8. Except the ERP all other integration are optional and can be
done in a phased manner. From the ERP following informa-
tion are essential to be extracted and provided to eBMR soft-
ware.
Bill of Material - Information about material required at each
stage.
Inventory Information - Information about inventory avail-
able. The material issues has to be sent back to ERP for record-
ing material consumption.
3) Plan out the infrastructure
As the eBMR has to be executed in realtime basis in the manu-
facturing floor. So there should be availability of device and
connectivity.
Best method is to execute the eBMR in a tablet device (iPad or
Android) connected on the wifi network to the eBMR server.
4) Define the testing and validation strategy
eBMR has 2 different and distinct components of softwares.
Template Designer
Product eBMR
The Template Designer can be validated like any standard soft-
ware. However as the Product eBMR defines and controls the
way the eBMR should work, it is important to ensure accu-
racy. Also the template designer allows write formulae and
script to achieve specific functionality. There should proper
planning done to ensure the accuracy of working of designer
as well as template from regulatory prospective.
5) Manage the transitions
From user friendly perspective the ‘paper on glass‘ requires
least amount change in terms of change. The eBMR can be
more intuitive compared to a paper based BMR. Still in terms
of physical working there is a change, an adequate change
management should be carried out. Designing the template
carefully and training the operators adequately is essential.
For overall ease of transitions, print outs of eBMR can be
taken, signed and stored during the transition phase.
6)Prioritize the products which are to be digitized.
From an implementation perspective, the migration of prod-
ucts can in done a a phased manner. Product should be se-
lected based on the complexity involved. There is a lot of addi-
tional benefits can be achieved in eBMR, which may require
change in the base BMR document itself.
Few examples are.
Include audio visual intuitive instructions
Include easy to understand controls to capture information.
Include steps to capture images as evidence for work done
7

9. Implement barcode scanning in eBMR for accurate informa-
tion capturing.
Simple products can be selected and migrated to eBMR, so
that added advantages can be evaluated.
8

10. CHAPTER 2
Technology
eBMR is built on the J2EE platform and
runs on the Oracle / DB2 database. The
eBMR can be accessed using the mobile
app available in iOS and android apps
store.

11. EBMR TECHNOLOGY
1.The Designer
2.Designer Application-eBMR Authoring Tool
3.eBMR Client
4.Semi structured database
5.Extend the functionalitySECTION 1
eBMR Technology
SECTION 1.1
The Technology Designer
The designer is a What You See is What You Get(WYSIWYG)
editor to create a template for a product. The designer on the
fly generates a html5, java script, jquery and css3 components
for each process, which is used in rendering the layout of the
eBMR. The user interacts with the layout like a web applica-
tion.
Template can be designed to achieve extremely custom looks
to match the need of the product. However if there is a need to
create a layout which is interactive in a extremely customized,
a free hand html + javascript program can be written and at-
tached to the process. In such a case, the designer functional-
ity is overridden with the free hand program.
10

12. SECTION 1.2
Designer Application
The designer application, also known as eBMR Authoring Tool is a
web based application which helps in
Design Master Template for an activity
Create a Process Route for a product
Associate the master template to an activity of a product.
SECTION 1.3
The Technology eBMR Client
The eBMR client is a native iPad and Android application, which
allows the user to execute the BMR using a hand held device.
Though the layout is rendered using dynamically generated html5
and css3 component, the eBMR has the ability take the advantage
of device hardware to capture information.
Capture a store and image using device camera. The camera im-
age in many instances can be used as an evidence of performing a
task. The camera image is stored along with BMR information.
Use barcode scanner to capture information.
Use video player to play multi media content to perform a illustra-
tive instructions
Capture information from a bluetooth enabled device. eBMR can
connect with external bluetooth enabled device and capture infor-
mation and integrate directly.
11

13. Use augmented reality for guided operation of complex proc-
ess. The eBMR supports a web API to invoke augmented real-
ity component. The component needs to be developed for
each process separately.
SECTION 1.4
SEMI STRUCTURED DATABASE
The information of eBMR for each product and process is com-
pletely different. Also over a period of time for the same prod-
uct and process the information can change.
From a data integrity prospective, the eBMR stores the instruc-
tions and layout information.
eBMR implements XML technology to store the information.
This maintains the complete layout, instructions, calculations
data observation in formatted as well as analyzable manner.
All the analyzable content in the eBMR is identified as a
unique variable name. The variable can be defined in the de-
signer. The variables can be calculated using arithmetic ex-
pressions. The expressions are defined in javascript language.
SECTION 1.5
EXTEND THE FUNCTIONALITY
Each components in eBMR is a standard based javascript and
html component. Additional components can be created using
the web technology.
12

14. CHAPTER 3
Design
Each product requires a specific eBMR
digital template.
The eBMR Designer helps to author, re-
view and maintain the eBMR templates.

15. THE EBMR TEMPLATE
1.Template
2.The Model and Variables
3.Layout and Components
4.Master template
5.Approval of eBMR templateSECTION 1
The eBMR Template
SECTION 1.1
Template
Template is the core definition of the eBMR. The eBMR tem-
plate has 2 distinct parts :
Model - defines the list of variables which will hold the infor-
mation, observation and calculations in an eBMR.
Layout - has the sequential instructions and varibles for the
process. The layout stores the information on how the eBMR
should look for a specific process. Predefined eBMR compo-
nents are provided by the designer for easier capturing of in-
formation.
Both these components together define the way the process is
to be performed.
The way the process is performed includes :
•The steps that are to be performed
•The sequence in which the steps are to be performed
•Instructions for performing the steps
•Variables in which information is to be captured
•Calculations to be performed, based on values cap-
tured
•Conditional flow of steps
14

16. SECTION 1.2
Variables
Variable is a definition of information that are to be captured
and stored during performing a step in eBMR. A value can be
assigned to a variable through an input component or a calcu-
lation. There are two types of variables -
a)Global Variable : can be used across any process within the
eBMR. The value contained in this variable is available
across all further processes.
b)Local Variable : can be used only within a specific process,
in which the variable is defined. The value contained in this
variable is not available to any other further process.
Fig BMR Application Designer - Variable definition
Variable Attributes
15
NAME ATTRIBUTE DESCRIPTION
Variable Name Unique name of the variable across the eBMR
Description Description explains the purpose of the variable
Type
Type of variable defines the type of information to
be captured in the variable. Type in eBMR
involves higher degree of encapsulation compared
to data types used in standard programming
language.
Type of variable also encapsulates the way the
variable should interact with the user in the step.
There are predefined components for each type of
variable, which is explained in detail in
components section
Minimum Value Minimum value that is expected to be captured in
this variable. If the observation is less than this
value, at run time the eBMR shows an exception.
Maximum Value
Maximum value that is expected to be captured in
this variable. If the observation is more than this
value, at run time the eBMR shows an exception.
Default Value
Optional default value that may be assigned to the
variable as initial value.
Calculation
Expression
Calculation expression can be defined in
javascript syntax, to calculate the value of the
variable. In this calculation expression can use
other eBMR variables.

17. SECTION 1.3
Layout and Components
The layout designer is a WYSIWYG html5 editor to design the
layout of the “instructions” and “variables”. The designer cre-
ates a XML model in which the variable values are to be
stored and a XSL which renders the layout.
eBMR layout template supports all html tags. Heading and la-
bels can be used to define the instructions.
There are pre-defined components which can be placed on the
eBMR layout for rapid designing. Depending on the type, the
component interacts with the user in a predefined way. To
specify how this component has to interact with the user, the
designer requires additional attributes. These additional attrib-
utes can be different for each type of components.
A component can be bound with multiple variables to store
the information which would be captured or generated during
execution.
Define the Layout
There are preconfigured layout defined in the eBMR designer.
A css3 document is associated with each layout. Each layout
by default provides a predefined sequence of steps. The layout
can be customized based on the requirement. The following
are typically found in a template -
Header : The static header of a template. This remains fixed
on top when the user scrolls down.
Steps: Steps are defined as html5 sections inside the template.
Each step is assigned an unique identifier, which determines
the sequence in which steps have to be performed.
Instructions and components required to perform the step
are defined herein.
The eBMR designer provides other html5 components like ta-
ble, list, bullets, paragraphs, etc. to design the layout.
The layout designer also supports text formatting like bold,
italic, underline and colors.
Types of Components
16

18. Text : is text information that can be captured and its value
displayed within the layout.
Number : can capture, store and display numeric information.
The numeric value can participate in calculations of others
variables.
Timestamp :
Timestamp stores the time. It shows a running clock on the
user interface. On touch or click of the clock captures and
stores the time. This type of component is used for capturing
“real time” information from the system clock.
Speed :
The speed component provides an interactive graphical inter-
face for capturing speed values for machine setting. The value
that has been set to the variable is shown in the center. The
value is also depicted in analog form, showing the knob posi-
tion. On touch or click of the control an interactive knob is dis-
played which allows to set the value. The value can also be
typed manually to set a specific number.
Heat :
The heat type of component is used for inputing and storing
temperature. A temperature icon is displayed. On touch or
click of the icon the system shows a thermometer control to
input the information. The value can be typed manually to
set a specific number.
Cool :
This is similar to the heat type of component. Only difference
is it indicates a cooling is required instead of heating.
Perform :
A perform type of component is used for displaying the time
stamp information and to indicate that the specific step is com-
pleted. On touch or click on the icon, the system displays
more information about the performer. The performer infor-
mation is captured by default within the eBMR when a step is
completed.
17

19. Check :
Once a task is performed, a checker needs to check and con-
firm that the task in the step was executed properly. Checker
icon allows a checker to confirm the step. The timestamp
shows the time when the checking action was confirmed. Like
perform, the check icon on a touch or click shows more infor-
mation about the checker.
Barcode Input :
The Barcode component is invoked to scan a barcode and ac-
cept the input, thus reducing human errors while recording
critical information.
Material Charging :
This component can be invoked when material has to be
charged to a vessel / machine. The process requires a barcode
scanning of the material before it is charged. The system vali-
dates the material details like Item code, Lot number, and the
Quantity which are part of the barcode information.
Invoke an external API :
This component provides a versatile tool to interface the
eBMR with devices,machines or another software application.
For example the API can be used to communicate with weigh
scale and fetch the weight directly to the eBMR. An API can
also be used to get machine parameters, outputs from testing
equipment.
Link to a document :
A process instruction may require a user to refer to a docu-
ment to effectively complete his/her task. This component pro-
vides an online access to the document and ensures that the
user is referring to the “right” version of the document.
Image :
This component allows the designer to place an image static
on the BMR page. When invoked it can display an image to
the user.
Link to a video :
18

20. This component retrieves a video from a repository to help the
user to understand the process and provide visual aid to help
complete the assigned task
SECTION 1.3
Master Template

Master template is the definition of the way a specific process
is executed. A master template is required to be defined for
each distinct way a process is executed.
SECTION 1.4
Approval of eBMR Template
Each BMR Master Template has to be reviewed and approved
before it can be used in eBMR.
19

21. EBMR PROCESS
1.Process Route
2.Create eBMR for a Product

SECTION 2
eBMR Process
SECTION 2.1
Process Route
The previous section we saw how the template for a process is
defined. However the manufacturing of a product involves
multiple processes to create finished goods from raw materi-
als.
We further need to define the sequence of processes to be per-
formed for a product. This is known as the process route. The
process route is further broken down to operations.
The operations are further broken down to activities that have
to be performed.
A master template is assigned to the product, which defines
the steps to be performed under a operation.
For Example
There will be a Process Route defined for a product - Tablet A
Which would entail multiple operations like Granulation,
Compression & Coating
Within the Granulation operation there would be activities
like Sifting, Blending and Lubrication
For each activity there would be a template associated.
To complete Lubrication a number of steps have to be fol-
lowed, which is defined in the template.
20

22. 21
Granulation
Sifting
Compression
Coating
Blending
Lubrication

23. CHAPTER 4
Execution
Once the eBMR design is done and ap-
proved, it can be executed while the prod-
uct is being manufactured.

24. MANUFACTURING EXECUTION USING EBMR
1.Overview
2.Create the work order
3.Firm Plan
4.Release
SECTION 1
Manufacturing Execution
SECTION 1.1
Overview
Manufacturing execution process involves the workflow from
the point of deciding to manufacture a batch of product to the
delivery of the finished product to the warehouse.
★Product definition (ERP)
•BOM
•Process Route
★Manufacturing
•Shop Order Creation
•Release Shop Order
★eBMR
•Pick- Weigh and dispense operation
•Perform Manufacturing Operation
★Completion of manufacturing - transfer the finished goods
to the warehouse
SECTION 1.2
Create the Work Order
23

25. Before you can work on an eBMR for a product and batch, a
work order (shop order) has to be created in the ERP system.
The work order defines following critical information about
the product and batch -
Item
Batch Number
Batch Size
Manufacturing Date
Expiry Date
Refer to ERP documents for more details on work order.
SECTION 1.3
Firm Plan
Firm planning a work order does the following -
Explodes the bill of material
Allocates Inventory to the work order
Explodes the process route
Allocates the work center to the process.
SECTION 1.4
Release
The work order release process sets the work order status as
“released”, which indicates it is set to start manufacturing.
During the release process the eBMR template is picked up
and a empty template is created for the work order. The
empty template is used during to execution process to fill up
manufacturing information.
24

26. SECTION 2
Pick Weigh and Dispense
PICK WEIGH AND DISPENSING
1.Overview
2.Scanning the barcode
3.Integrating with weighing scale
4.Handling excess and shortage
SECTION 2.1
Overview
Pick weigh and dispense introduces electronic material man-
agement in weigh and dispense areas. It enables work order
related material tracking for the W&D process and ensures
GMP compliance as defined in the FDA guidelines. 
•Provides intuitive, user-friendly controlled dispensing to en-
sure dispensing accuracy
•Check the correctness of the information, e.g. item number,
batch (number, status and expiry date), sub batch (number,
status)
•Handle tare, net weight and gross weight and receive them
directly from weigh scales
•Ensure usage of the allowed quantity of components and pre-
vent operators from weighing unapproved quantities
•Provides real-time calculations for potency adjustment
•Manage actual quantity of components to be weighed. Man-
age additional quantity/sub-batch of a component to be
weighed
•Operate scale information and interface scales directly from
the WSD interface
•Generate bar code labels for the source and destination con-
tainers
25

27. •Maintains audit trails
Overview of the Process
Integration of the module with the ERP ensures that raw mate-
rials and ingredients to be issued are based on the BOM or
recipes defined and the SOPs.
This integration brings about significant improvements in effi-
ciency, performance and an enhancement of the right-first-
time factor for weighing, leading to improvement in product
consistency and reduction of wastage. It allows organizations
to track any problems, determine root causes and meet man-
dated reporting and tracking requirement. 
26
Dispensing Process

28. PERFORMING MANUFACTURING
1.Overview
2.Performing Manufacturing
3.Checking Process
4.Review of eBMR
SECTION 3
Perform Manufacturing
SECTION 3.1
Overview
During a manufacturing execution process, the eBMR is filled
using the eBMR Mobile application. The steps are performed
by the performer and the checker checks to ensure that the
steps are being performed as expected.
On completion of a process
the duly completed eBMR
must be reviewed by the re-
viewer.
The user manual provides
a detailed explanation on
how to perform various
tasks with examples.
SECTION 3.2
Performing Manufacturing
The Performer selects Work Order->Process->Activity to acti-
vate the template for the activity on the eBMR Mobile applica-
tion.
A preview mode displays the entire unit activity on the screen.
The performer selects the step next, command to perform the
next required step. The eBMR Mobile Client, automatically ac-
27

29. tivates the next eligible step in the template. From the tem-
plate layout system activates the block of eBMR, relevant for
the task is highlighted. The performer reads the instructions
and performs the task as described. He may capture informa-
tion during this process which is stored in the eBMR data
model.
Once the task is completed, the performer selects the “task
completed” option, which places the users’ digital signature
against the task.
The performer will not be able to alter any information on the
tasks that are “completed”.
SECTION 3.3
Checking Process
In order to confirm that a process has been executed as per re-
quirement the “checker” has to be login to the eBMR and navi-
gate to Work Order->Process->Activity as a checker. The
steps which are already completed can be confirmed by the
checker. The checker will not have rights to carry out any
modification in the eBMR information. He/she can, however
mention a remark towards specific tasks, if there was any de-
viation during manufacturing.
On confirmation of the task by the checker, his /her signature
shall appear against the task.
While designing the eBMR, the tasks that need a checker con-
firmation need to be identified, and place holders for checker
have to be created.
SECTION 3.4
Review Process
Once the process is completed, the eBMR for the said process
is forwarded to the designated reviewer for review and ap-
proval. Multiple level reviews and approval workflows can be
defined in the workflow engine.
The reviewer gets a notification that a review task has to be
performed. The system provides a preview of the completed
eBMR of the process. The reviewer can view the exceptions in
variables range in the eBMR highlighted in red color.
The authorized reviewer can change selected value in the
eBMR before his approval by providing a reason of change be-
fore his approval.
Once the review process is completed it is locked from editing
and can not be changed.
28

30. BMR
BMR, Batch Manufacturing Record
Related Glossary Terms
Index
eBMRFind Term

31. eBMR
Electronic Batch Manufacturing Record.
Related Glossary Terms
Index
BMRFind Term

32. Paper on glass
Paper on glass is a term used to define a methodology used in automating the BMR in
electronic medium. The exact layout of the physical paper is reproduced on the elec-
tronic screen and execution is done.
Related Glossary Terms
Index
Drag related terms hereFind Term