Record integrity
Production data must be recorded at source, timestamped and with user context.
/ INDUSTRIAL SOLUTION
02
MES Pharma
Paperless, traceable and controlled operations management for pharmaceutical manufacturing.
Consolidate electronic batch records, operator routing, material tracking, quality checks and electronic signature flows on the production floor into a single MES backbone.
Explore the solutionDo not just digitize the production instruction; Execute each step in the correct product, material, equipment, and authorization context.
Process discipline
Operations must proceed according to the approved MBR, current instructions and defined tolerances.
Quick review
Quality teams should be able to focus on deviations and exceptions rather than scanning the entire record from scratch.
/ ELECTRONIC BATCH RECORDGuide production,
Guide production,
create the batch record in real time.
MES Pharma turns the operations in the master batch record (MBR) into executable shop-floor steps. Operator entries, automation data, material consumption, equipment status and quality results are combined in the electronic batch record.
GuideGuide the operator through the correct step
RecordRecord actual results at the source
ReviewReview exceptions quickly
- Approved production flowVersion-controlled MBRs, instructions, parameters and control points are used.
- Electronic signaturesCritical steps are managed through role, authority and signature requirements.
- Review by exceptionOut-of-tolerance values, alarms and deviations are highlighted for review.
From ERP order to batch release,
data that does not lose its context.
Work order, recipe, material, equipment, process and quality information progresses in the context of a common batch with controlled integrations.
PLANEXECUTIONEVIDENCE
/ MES PHARMA CAPABILITIESAt critical points in regulated production,
At critical points in regulated production,
control, traceability and evidence.
Scope; It is structured according to product type, facility architecture, quality system and verification strategy.
Master batch record
Product, process, source and quality steps are defined by a version-controlled master record.
Electronic batch record
Manual and automatic realizations in a single, searchable batch file is collected.
Weighing and distribution
Lot, expiration, condition, weighing tolerance and material consumption are verified.
IPC and sample flows
In-process controls, sample requests and result confirmations are associated with production.
Audit trail and signature
Critical changes, user actions and electronic approvals are kept trackable.
ERP, LIMS and automation
Work order, quality result and process data are integrated with controlled interfaces.
Execute the right step with the right person,
under the right conditions.
MES doesn't just collect data; It also enforces business rules that prevent the operation from progressing if defined preconditions are not met.
Resource and material
Status, authority and availability is verified.
→Instruction and process
Approved steps are executed.
→Alarm and deviation
Out of tolerance condition managed.
→eBR and release
Batch proof quality is presented.
Proceed from use case to live system,risk-based and controlled.
- 01Determine scope and target
Product family, line, regulation scope and measurable business objectives are clarified.
- 02Extract process and data model
MBR, roles, equipment, material, exception and data flows are modeled.
- 03Design integrations
ERP, LIMS, warehouse, identity management and automation boundaries determined.
- 04Configure the pilot
A highly representative product flow is digitized end-to-end.
- 05Verify and commission
Risk assessment, test evidence, training and operating procedures is completed.
- 06Template and scale
The approved model spreads to other products, lines and facilities in a controlled manner.
MES architecture
adaptable to different pharmaceutical production structures.
Solid dosage
Weighing, granulation, tableting, coating and packaging processes.
Liquid and semi-solid
Preparation, mixing, transfer, filling and line cleaning operations.
Sterile production
Environmental conditions, aseptic steps and critical intervention records.
Biopharma
Complex batch flows, material pedigree and in-process quality controls.
MES Pharma provides technical controls that support the compliance process; Final compliance is managed with validated system lifecycle and operating procedures.
21 CFR Part 11
Supports access, authorization and registration controls under electronic records and signatures.
EU GMP Annex 11
Supports design that complies with risk management, security, audit trail and lifecycle expectations in computerized systems.
GxP verification
User requirements, risks, test evidence and change control are included in the project scope. is taken.
How we turned a similar need
into an operating solution.
Customer and facility information has been anonymized to meet confidentiality obligations.
Let’s assess MES/MOM fit
for your production operation.
We will review your current systems, priority use cases and integration needs with the relevant engineering team.
Request an MES fit assessment Your request is routed directly to the relevant engineering team.