Production

Pharmaceuticals

Batch control, quality, regulatory requirements and full traceability of the manufacturing process.

Key capabilities

GMP validated processes

Electronic batch records

Batch control and quarantine

Deviation Management (CAPA)

Audit trail of every action

Serialization and reports

Practical examples

FAQ

Do you meet GMP requirements?

Yes, with validation package (IQ/OQ/PQ) and full audit trail.

Do you support electronic signatures?

Yes, with role-based permissions and record locking.

How is the quarantine of incoming raw materials managed?

Each delivery enters a quarantine area and is released only after an approved QC protocol with an electronic signature.

Do you maintain a CAPA process?

Yes - registration of deviation, investigation, corrective and preventive actions with deadlines and responsible persons.

How is system validation done?

With a complete package of IQ/OQ/PQ documentation, test scenarios and inspection-acceptable protocols.

Is serialization and Track & Trace possible?

Yes, we support generation and reporting of unique identifiers by packaging and aggregation.

Tell us about your goals - we will contact you to discuss consultation options.