Industry
Electronic batch records, recipes and process data for chemical and pharmaceutical plants
We place process values from reactors, mixers, granulators and filling equipment into an ISA-88 batch structure and link them to recipes and quality records.
Our clients
- Siemens
- Anadolu Isuzu
- BSH
- Tofaş
- Toyotetsu
- Martur
- Turkcell
- Vodafone
- Doğadan
- Pakmaya
- Bross
- Abdi İbrahim
- Nobel İlaç
- Plastimak
- Dalgıç Kalıp
- Barbaros Motor
- Magneti Marelli
- Rözmaş
- Sanel
Every batch in chemical and pharmaceutical manufacturing closes with a set of documents: recipe, charge quantities, temperature and pressure profiles, deviations and sign-offs. In many plants that record is still assembled from paper batch sheets, printouts from equipment screens and separate chart recorders.
VOLSOFT takes process data from the controllers of reactors, mixers, dryers, granulators, tablet presses and filling machines, or from the existing SCADA/DCS. The data is modeled per batch, phase and step along ISA-88 lines, with recipe and material data coming from the ERP.
The goal is less manual compilation of batch records and deviation reviews based on data. For records that will be used in a validated system, the structure is designed with the client's quality and validation team, with GMP, 21 CFR Part 11 and EU GMP Annex 11 requirements in view. Every project runs on Proxus.
What we deliver
Chemicals and pharma
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ISA-88 batch structure
Process data is kept in a batch, unit procedure, phase and step hierarchy, so every value is stored knowing which step of which batch it belongs to.
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Recipe and charge data
Recipe parameters and material lots come from the ERP; weighing and dosing values are recorded as the actual charge.
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Process profiles and deviations
Temperature, pressure, pH, agitator speed and flow profiles are stored in the historian. Out-of-limit values are flagged for deviation review.
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Audit trail and access
Who changed which value and when is recorded; user roles and access rights are designed together with the data model.
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Tablet, capsule and filling lines
Counts, rejects and stoppages on tablet presses, capsule fillers and blister machines are kept with OEE and the batch record.
Processes we work on
Where the data starts in chemicals and pharma
- Reactors and mixing vessels
- Distillation and crystallization
- Granulation and fluid bed drying
- Tablet presses
- Capsule filling and blister packaging
- Liquid and cream filling lines
- Weighing and dispensing stations
- Purified water and HVAC monitoring
- CIP/SIP systems
How a project runs
From discovery to live, step by step
- 01
Process and requirements analysis
Equipment, the existing SCADA/DCS, recorders and batch sheets are reviewed on site. With quality and validation, we decide which records fall under which requirements.
- 02
Data model and ISA-88 mapping
Units, phases and steps are defined and tags are mapped to them; naming and access rules are documented.
- 03
Pilot unit
Data collection and batch records go live on one reactor or line, and results are compared with the existing paper record.
- 04
ERP integration and rollout
Recipes, materials and production confirmations are connected to the ERP. Further units are added, users are trained and documentation is handed over.
Built on Proxus
Proxus stores time-stamped process values in its historian, makes them queryable by batch and step and passes them to the ERP and quality systems.
Proxus is the industrial data platform built by the VOLSOFT team.
Frequently asked questions
Common questions
What is ISA-88?
ISA-88 is a standard that defines how recipes, equipment and procedures are modeled in batch manufacturing. It describes a process as a hierarchy of batch, unit procedure, phase and step. That structure lets process data be recorded consistently against the batch and step it belongs to.
What data is collected for an electronic batch record?
Recipe parameters, material lots, weighing and dosing values, process profiles such as temperature, pressure and pH, alarms, deviations and user actions. Which records are mandatory depends on the plant's quality system and the regulations it falls under.
Can data be taken from an existing SCADA or DCS?
Yes. Data can be read from the existing SCADA/DCS over OPC UA or from its database without changing the control system. Where needed, we connect to equipment controllers directly.
Is the system ready for GMP validation?
Validation is the plant's own process and is run by the client's quality team. VOLSOFT designs the audit trail, access control and documentation to support that process and works alongside the validation team.
How long does a project take in a chemical or pharma plant?
It depends on the number of units, the record requirements and the validation scope. Projects usually start with a pilot on one unit or line, and the scope is set during the discovery call.
Related pages
Often looked at together
- Solution Process Monitoring Process values tracked by recipe and batch, with SPC, alarms and batch reports. Explore →
- Service Industrial Data Governance ISA-95 data model, tag naming, data ownership, access control and IT/OT security. Explore →
- Service ERP–MES Integration Work-order and production feedback integration with SAP, Dynamics and other ERPs. Explore →
- Technology OPC UA integration Connecting to OPC UA servers with security modes and certificates, node selection and data modeling. Explore →
- Service Dashboards and Reporting Line screens, shift and management reports, plus integration with existing SCADA and historians. Explore →
Next step
Let’s turn your goal into a clear engineering scope.
Tell us about your plant, your machines and your goal. An integration engineer will set up a discovery call with you.
