The operator writes.
The document is filled in and then filed away.
Electronic Batch Record · Digital Batch Record
Don’t digitize the form. Digitize manufacturing.
Design your formulas, processes, screens, controls and printouts. Turn the execution of every batch into digital, traceable, connected evidence.
For pharmaceutical, cosmetics, food and other regulated manufacturers.
Digital manufacturing thread
From the planned process to what actually happened
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01
Master formula
Current version · 2.4
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02
Production order
Sample batch · active order
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03
Weighing
Raw material · quantity · operator
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04
Manufacturing and controls
Stages · equipment · parameters
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05
Review and release
Results · approval · evidence
User
Date and time
Material
Equipment
Result
Signature
FastOfi knows what was supposed to happen and records what actually happened, based on the configured process.
A question for your operation
Is your Batch Record truly digital?
Digitizing a form doesn’t mean digitizing manufacturing. Watch this concept piece and think about everything that happens between an instruction and the release of a batch.
It isn’t a product tutorial: it’s an invitation to rethink what an EBR should record.
More than a document
A Digital Batch Record is much more than an electronic form.
A form lets you type on a screen. An EBR can digitally represent and record how manufacturing is executed: formula, materials, stages, activities, operators, equipment, controls, results, approvals and evidence.
The operator types on a screen.
The record is stored digitally, but it is still a form.
The process guides and connects.
It can validate, control, keep evidence and feed other processes.
A digital form records what you type.
A digital process records what you do.
FastOfi is designed to support this third level.
Execution evidence
Every process leaves a digital footprint.
Structure each activity with the information your process needs to link to the batch.
Weigh
Raw material, batch, theoretical and actual quantity, tolerance, user, time, equipment and result.
Manufacture
Stage, materials, parameters, operator, equipment, times and notes.
Control
Variable, expected value, result, tolerance, owner and acceptance.
Clean
Area, equipment, procedure, owner, date, result and evidence.
Approve
User, role, date and time, decision, signature and notes.
What happens on the plant floor is recorded digitally.
Configuration, not programming
Build your Batch Record. No coding.
Your team knows the process. FastOfi gives them the tools to turn that knowledge into a digital workflow that authorized people in your organization can configure.
- 01 Design your formula
- 02 Define your stages
- 03 Design your screens
- 04 Set up controls and rules
- 05 Define approvals
- 06 Design your printouts
- 07 Run the batch
- 08 Get the digital batch file
Your process changes. Your EBR can change with it.
Formulas
From master formula to manufacturing logic.
Organize components, quantities, units, tolerances, instructions, stages and versions to fit how your operation is configured.
FORMULA → PROCESS → EBR
Screens
The screen adapts to the process.
Configure numeric fields, material selection, controls, tolerances, instructions, photos, documents, signatures and evidence for each stage.
Build the screen your operator needs.
Printouts
The batch file also generates documents.
Use the captured data for the Batch Records, orders, process records, labels, reports and internal documents you configure.
RECORD ONCE. USE THE INFORMATION MANY TIMES.
Routine process configuration can be done by the authorized team without software development for every change. The scope depends on each organization’s configuration and permissions.
Connected information
Production data can work for the whole company.
Information shouldn’t be locked inside a form. When the process is digital, data can be linked and reused based on the available integration capabilities.
One operation. One data point. Many uses.
PRODUCTION PROCESS
One reliable data point
Captured during execution
Production
Inventory
Quality
Traceability
Equipment
Maintenance
KPIs
Audit
Documentation
Batch traceability
From formula to release.
Link the batch to its activities, materials, users, equipment, dates, times, results and approvals.
Data integrity · ALCOA+
- Attributable
- Who performed the activity
- Contemporaneous
- When it was recorded
- Original
- Which record is the source
- Accurate
- What actually happened
- Complete
- What information was linked
- Consistent
- How traceability is maintained
- Weighing started
- Raw material identified
- Quantity recorded
- Control approved
- Process started
- In-process control
- Stage completed
- Quality review
- Release
Regulated operations
Designed to build digital evidence of what happened during manufacturing.
FastOfi includes capabilities focused on the integrity, traceability and evidence management of production records.
BPM
Good Manufacturing Practices (Colombia)
Good practices built into operating and recording workflows.
INVIMA
Regulated processes and documentation
Configurable records and forms to support the applicable regulatory processes.
21 CFR Part 11
Signatures and audit trail
Electronic signature, traceability and history capabilities aligned with the applicable requirements.
GMP
Good Manufacturing Practices
Structured processes for environments that require control and record integrity.
ISA-88.00.04
Concepts for structuring and modeling batch processes.
GAMP 5
Relevant principles for regulated computerized systems.
ALCOA+
Attributes that guide data integrity and traceability.
These references are not automatic certifications and do not guarantee regulatory compliance. Final compliance depends on each organization’s implementation, configuration, procedures and use.
Impact on your operation
More control during execution. More context afterwards.
Less paper
Digitize records and processes that rely on paper forms today.
Less data entry
Capture information while the process is running.
More traceability
Link users, batches, processes, equipment, materials and results.
More control
Build rules, validations and approvals into the configured workflow.
More flexibility
Adapt formulas, screens, processes and printouts.
More information
Turn manufacturing data into useful information for other areas.
Process flexibility
Your operation changes. Your Batch Record can change too.
Formulas
Products
Pack sizes
Controls
Equipment
Stages
Approvals
An EBR shouldn’t become a straitjacket. Configure the process so it can evolve with your operation, within your organization’s permissions.
Configure your process. Don’t rebuild your software.
Designed for manufacturing
A digital process that adapts to your industry.
Pharmaceutical
Formulas, weighing, manufacturing, controls, traceability and release.
Cosmetics
Batch processes, raw materials, controls and documentation.
Food
Production, parameters, controls and traceability.
Other regulated industries
Configurable processes and digital manufacturing evidence.
What would your Batch Record look like if it were designed around your process?
Show us how you manufacture today and see how that process could look in FastOfi.
Frequently asked questions
Clear answers to get started.
Is FastOfi a digital form?
No. FastOfi lets you configure digital workflows to execute and record complete production processes, not just capture text on a screen.
Can I design my own Batch Record?
Yes. The solution lets you configure formulas, processes, screens, controls, approvals and printouts to fit your organization’s needs and permissions.
Do I need a developer to change my EBR?
The authorized team can make routine process configuration changes without relying on software development for each one. The exact scope depends on how the solution is implemented.
Can I change my formulas and keep versions?
FastOfi supports formula and version management according to the organization’s configuration.
Can I create different screens for different processes?
Yes. Screens can be configured for the needs of each stage, including fields, controls, instructions and evidence.
Can I generate the Batch Record as a document?
Yes. Captured data can be used to generate the printouts configured by the organization.
Does FastOfi record who performed each activity?
The platform can link the user, date, time and other activity information, according to the implemented configuration.
Does FastOfi have an audit trail?
FastOfi offers traceability and change history capabilities. The scope and available evidence depend on implementation and configuration; regulatory suitability must be validated for each use.
Is FastOfi suitable for regulated processes?
It is aimed at companies that need to structure, control and keep digital evidence of their manufacturing processes. The solution supports, but does not replace, each organization’s validation and procedures.
Can I integrate the Batch Record with Inventory and Quality?
Data can be linked within the FastOfi ecosystem. Integrations and available scope are reviewed with the team based on your operation.
The next step
Don’t turn your Batch Record into just another form.
Turn your manufacturing into a digital process. Design your formulas, configure your processes and record what happens to build a traceable digital file for every batch.