Proteus has over 20 years of experience addressing the needs of the Pharmaceutical Industry. Vision ERP addresses Pharma processes for the Manufacturing, Supply chain, Salesforce, and Compliance requirements.
Our customers range from Start-Up companies to large Multi-national Pharmaceutical companies with operations in multiple geographical regions.
Pharmaceutical ERP (Enterprise Resource Planning) is a specialized business management suite tailored for the life sciences industry. Unlike standard software, a Pharma ERP integrates formula management, quality control (QC), and regulatory reporting into a single source of truth.
Why it’s essential: Pharma manufacturers face unique challenges like short shelf lives, stringent FDA/MHRA audits, and complex chemical formulations. Without a specialized system, risks of cross-contamination, failed audits, and manual data errors skyrocket.
Features and solution architecture that will assist you in a smooth compliance like 21 CFR Part 11, GAMP 5, and ALCOA+ principles.
Precise tracking of API (Active Pharmaceutical Ingredient) consumption.
Gain visibility into every stage of production, linking raw materials to final dispatched units.
Streamlined procurement and quality testing cycles.
One of the most critical requirements for any pharma company is the ability to conduct a mock recall or trace a product instantly. VISION ERP provides bi-directional, end-to-end traceability.
When a batch is initiated, a unique Work Order is linked to a specific FG Lot Number. As materials are issued, the system records exactly which raw material lot numbers (including supplier batch data) were consumed.
Beyond Materials: It also logs the specific machines, equipment used, and the personnel involved at every stage.
If a quality issue arises in the field, you can enter the FG Lot Number to instantly see the entire genealogy. You will identify the exact Work Order, the specific chemical batches used, and the supplier details, enabling a targeted and surgical recall rather than a costly mass withdrawal.
Feature | Specialized Pharma ERP (e.g., VISION ERP) | Generic ERP (Tally, SAP B1, ERPNext) |
Inventory Logic | Lot & Batch Centric: Tracks specific chemical lots, potency variations, and re-test dates. | Item Centric: Primarily tracks quantity on hand without deep batch genealogy. |
Regulatory Compliance | Native 21 CFR Part 11: Built-in electronic signatures and immutable audit trails. | Manual/Optional: Often requires expensive third-party add-ons or manual record-keeping. |
Quality Control (QC) | Hard-Stop Integration: System prevents sale or movement of any batch until QC clears it. | Soft Integration: Usually a manual “status update” that can be bypassed by users. |
Production Records | Automated BMR/BPR: Generates Batch Manufacturing/Packing Records in real-time. | Generic Work Orders: Designed for assembly lines, not regulated chemical processes. |
Expirations | Automated FEFO: System automatically locks expired stock and enforces First-Expiry usage. | Basic Alerts: Usually just a date field; does not typically “lock” the inventory from use. |
Traceability | Bi-directional: Instant “Seed-to-Sale” tracking. | Fragmented: Often requires manual cross-referencing of different ledgers or reports. |
Manage complex SOPs and bill of materials (BOM).
Manage complex SOPs and bill of materials (BOM).
Integrated sampling plans and COA (Certificate of Analysis) generation.
Real-time recording of shop floor activities
Manage carrying and forwarding agents (C&F), schemes, and expiry returns.
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