The electronic batch record, in real time
DataFlows Pharma is the manufacturing management system for medicines, cosmetics and food supplements. It covers the journey from raw material receipt to batch release: quality control, manufacturing, packaging, warehouse and delivery, with an audit trail and electronic signature at every step.
- Built on the requirements of EU GMP, Annex 11 and 21 CFR Part 11
- Electronic batch record on a tablet, with verification by scanning
- Integrated warehouse, with stock tracked on every container
Benefits
In many plants, the batch record is still printed, filled in by hand and then checked line by line by quality assurance. Every transcription is a chance for error, and releasing a batch can wait for days because of a missing signature or an illegible figure.
DataFlows Pharma moves these records to where the work is done. The operator runs the procedure step by step on a tablet, scans the materials and enters the parameters, while the system checks quantities and limits on the spot. Quality assurance looks only at what went out of parameters.
Raw materials, laboratory results, quality decisions and deliveries sit in the same place, with a full history for every batch.
From raw material receipt to batch release
Every stage is recorded at the moment it happens, on a computer or on the mobile terminal, and the documents come out of the data already entered.
Receipt and quarantine
Raw materials enter the system in two stages: quantitative receipt against the purchase order, and approval of each batch. Until the quality decision, the stock stays in quarantine and cannot be used.
- Own label on every container, mandatory scan before approval
- Checks at receipt: clean containers and transport, temperature, the supplier’s certificate of analysis
- Purchase orders only to suppliers approved for that item
- Supplier’s batch, manufacturing date and expiry or retest date
- The supplier’s unit of measure is converted automatically to the stock unit
Sampling and testing
The laboratory receives samples per batch and enters the results for every requirement in the active specification. The verdict is calculated automatically, and the batch becomes usable only when all results are compliant.
- Initial sampling, retest or resampling, with the quantity movement in stock
- Certificate of analysis generated for every sample
- A non-compliant result automatically opens an OOS investigation, which blocks batch release
- Trends outside the usual values (OOT) are flagged before they become non-conformities
- QA decision per batch, with document number and date, separate from the QC role
Manufacturing with an electronic batch record
The operator receives the batch record on a tablet and goes through the steps in order. They cannot skip a step and cannot add any material other than the one specified in the procedure.
- Material addition with identity scanning and quantity tolerance check
- Line clearance as a checklist, before start-up
- Process parameters and in-process controls (IPC), with an on-the-spot verdict
- Signature on every step, plus a witness for critical steps
- Uncleaned equipment or expired calibration: the step requires a reason and becomes an exception for QA
Packaging, reconciliation and release
At the end, the system balances the materials: how much the department received, how much was consumed, how much goes back to the warehouse and how much was lost. The finished product gets container labels, and the batch is released by signature.
- Automatic material reconciliation, with loss thresholds per item
- Return of unused materials to the warehouse, with approval
- Container plan for the finished product, with labels generated by the system
- The labelled batch is visible in stock but cannot be used until the release signature
- QA review of the batch record, by exception, closed with an electronic signature
Warehouse and delivery
The warehouse works with DataFlows Depo, on the same data. The batch’s quality status appears at every scan, and an expired batch cannot be delivered.
- Transfers from the warehouse to the department, with preparation, scanning and confirmation at destination
- Stock statuses: quarantine, approved, rejected, returned, damaged and more
- Batch and container allocation on sales orders, with partial deliveries
- Stock counts through scanning sessions, closed with a signed approval
- Dispatch under signature, from the mobile terminal
Returns and market recalls
Starting from a batch, you immediately see which customers received it and in what quantity. The recall is approved, quantities are reserved, and the return is received into stock with the right status.
- List of orders and customers that received the batch, grouped by customer
- Quantity to recall on every position, with approval
- Customer returns, with relabelling and complaint flag
- Return to supplier by container, with scanning and confirmation
The quality system, in the same application
Deviations, corrective actions and changes no longer sit in separate spreadsheets. They start from production or the laboratory and stay linked to the batches they affect.
Data integrity, verifiable at inspection
Software isn’t certified, it is validated at the user’s site. We build the application on the requirements inspections look for and give you the documents validation starts from.
What an inspector finds in the system
- Audit trail on every record: old value, new value, author, time and reason
- Electronic signatures with meaning (performed, verified, approved, released, witnessed), with password re-entry
- The signature stays bound to the signed data; if the data changes, it shows as outdated
- Mandatory reason when changing critical fields and GMP settings
- Separation between who requests and who approves, with no administrator bypass
- Permissions by role and department, with a menu adapted to each role
The validation package
- User requirements (URS) with a traceability matrix
- Risk analysis and position against Annex 11 and 21 CFR Part 11
- Data integrity statement, based on the ALCOA+ principles
- IQ, OQ and PQ qualification templates
- Procedures for users and roles, backup, continuity, incidents and audit trail review
- GAMP 5 classification, category 5
From the raw material container to the customer
You can start from either end: from a bag of raw material, from a batch of finished product or from an order.
Labelled container
Every drum or bag has a QR code with the item, the batch and the container number. You see how much is left in it and where it was used.
Manufactured batch
Actual consumption is recorded on every raw material batch. The request, the production order, the return and the losses are linked in a single timeline.
Delivery and recall
You know which customers received every batch. In a recall, the list of affected orders is ready, grouped by customer.
Production planning, on real stock
The production plan starts from orders and real stock, not from a separate spreadsheet. You see in advance whether you have the approved raw materials and whether the department and equipment are available.
- Batches planned from sales orders and the minimum stock of finished product
- Raw material check before launch, only on approved and unallocated batches
- Material requirements calculated from the recipe, for the size of each batch
- Campaigns: several batches from the same recipe, launched together
- Open purchase orders count as future stock
- Calendar by department and equipment, with cleaning and calibration status visible when scheduling
Pharma, cosmetics and food supplements
The same base, configured to the rules of each field. In the app you’ll also find a legislation section with the official sources for each field, plus a GMP glossary.
Medicines
For medicine manufacturing, the system follows EU GMP requirements, with a focus on the batch record, batch release and data integrity.
- Electronic batch record and QA review by exception
- Audit trail and electronic signature, following the principles of Annex 11 and 21 CFR Part 11
- Stability studies and retest dates tracked
- Serialisation for prescription medicines (FMD): batch-level record, with sales blocked if incomplete
- Market recalls started from the batch
Cosmetics
For cosmetics, records follow the good manufacturing practices of ISO 22716 and the requirements of Regulation 1223/2009: traceable batches, controlled specifications, tracked deadlines.
- Versioned recipes and procedures, approved before use
- Batch traceability, from raw material to delivered product
- Quality control per batch, with a certificate of analysis
- Labels on containers and on the finished product, generated by the system
- Returns and complaints linked to the batch
Food supplements
For supplements, what matters besides traceability are raw material specifications and shelf life. The system keeps records per batch and blocks the delivery of expired batches.
- Versioned specifications per item, with QA approval
- Receipt with verification of the supplier’s certificate of analysis
- Batches, expiry and retest dates tracked automatically
- In-process controls and material reconciliation
- Records ready for HACCP principles and customer audits
Implementation and validation
The duration depends on the number of products, procedures and connections to the ERP. We set it after the process analysis, together with the validation plan.
Process analysis
We start from your current procedures and batch records and write the user requirements together.
Configuration
We enter the recipes, master procedures, specifications and approval workflows, by the roles in the plant.
Data and connections
We import items, stock and partners from the ERP, in a test run first.
Validation
We carry out the IQ, OQ and PQ qualification based on the validation package and the traceability matrix.
Training and go-live
Operators, the laboratory and QA work on real batches, with us alongside in the first weeks.
Questions we hear often
A computerised system is validated at the user’s site, on their processes. We give you the validation package: user requirements, traceability matrix, risk analysis, IQ/OQ/PQ templates and operating procedures. We carry out the validation together with your quality team.
The system is treated as configured and custom-developed software (category 5), and the validation documentation starts from that classification.
No. Log entries are only ever added; they cannot be edited, deleted or switched off, not even by an administrator. Critical fields require a reason for every change.
Every signature has a meaning (performed, verified, approved, released, witnessed) and requires password re-entry. The signature is bound to the signed data: if the data changes later, the signature shows as outdated and has to be redone.
Yes. We start from them when building the master procedures. The steps, parameters and controls stay yours; only the place where they are filled in changes.
Yes. Items, stock, partners and production steps are imported in a controlled way, with a test run, and permanent connections are made over API.
Weighing is recorded by scanning the material and entering the quantity, with a tolerance check. A direct connection to scales is under development. Label printers are already integrated.
On your own server, in the plant’s network, or in a dedicated cloud. Backups are configured locally or externally, with the retention period you choose.
Yes. The basic flows are the same: batches, specifications, quality control, traceability. What differs are the rules enabled and the documents generated, which we configure for your field.
Starting from the batch, the list of orders and customers that received it is generated on the spot. The recall is approved and tracked in the same system.
The batch record with all signatures, the audit trail of every record, the deviations and CAPAs linked to the batch, laboratory results and equipment history, without having to gather them from several places.
Yes. You can start, for example, with the warehouse and quality control, then move on to the electronic batch record. We agree on the order during analysis.
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