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1. Serialization & Traceability Consulting
1. Serialization & Traceability Consulting
We provide expert consulting to help pharmaceutical companies design and implement serialization and traceability solutions that meet global compliance requirements. Our services cover:
End‑to‑end solution design and implementation
Partner and Product Onboarding
Integration across Level 3, Level 4, and Level 5 systems
Compliance with GS1 standards and regulatory mandates
Ongoing support for system upgrades and audits
EPCIS Issue management
2. Computer System Validation (CSV)
2. Computer System Validation (CSV)
Validation is one of the most critical aspects of the pharma industry. We offer:
Risk‑based validation strategies aligned with FDA, EMA, and MHRA guidelines
Validation of both software and hardware systems
Audit‑ready documentation and compliance deliverables
Support for inspections and regulatory reviews
3. Electronic Validation Services
3. Electronic Validation Services
We strongly recommend electronic validation for efficiency and compliance. Our team are experts in the ValGenesis electronic validation tool, offering:
Paperless validation processes
Streamlined documentation management
Compliance with 21 CFR Part 11 and Annex 11 requirements
Our Services
Partner Onboarding
Smooth serialization on-boarding for partners with complete compliance according to country regulation.
Data Management
Data managed as per the ALCOA principle. With this we met serialization data security & integrity requirements.
EPCIS Data Handling
EPCIS data issues (V1.0, 1.2) are identified, resolved, and investigated for smooth supply chain operations.
Issue and Change Mangament
Requests and Incidends are managed and resolve as per the SLA. The changes are evaluated and implemented as per the partner Change managment process
Software and Hardware Validation
Validation plays crucial role in pharma industry. Every software and hardware validated, as per V model adhere to GxP Process.
DSCSA Integration
DSCSA is now enforce in USA and mandatory for prescription drugs in finished dosage. This need integration with between CMO's, wholesalers and distributor with smooth data flow.
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