Pharma Express^sm is a pre-configured, integrated and enhanced ERP solution for the life sciences industry.

Companies in the Life Sciences industry are faced with a host of challenges including reducing time to market, consistent and better product quality, increasing time to value, improving product safety, softening margins and downward pricing pressures. Globalization, mergers and acquisitions pose additional challenges to IT in providing an integrated, compliant, and enterprise-wide platform to support the ever-changing and increasing demands from business and regulatory agencies worldwide.

Pharma Express^sm for SAP from Intelligroup helps companies meet the above challenges in a cost-effective manner. Pharma Express^sm is a scalable solution that can be deployed for both SMB's and large-scale companies. It can be reconfigured to meet the business needs of biotechnology and medical device/diagnostics industry segments. A hosted version of Pharma Express^sm in a completely validated data center, as a packaged solution, is available for SMB companies to achieve a lower TCO without compromising on compliance and validation.

Pharma Express^sm: Intelligroup's Pre-configured, Integrated and Enhanced SAP Pharmaceutical Industry Solution

Pre-configured Solution for Critical Life Sciences Processes
Pharma Express^sm is built using Intelligroup’s expertise in regulatory affairs, domain knowledge and deep ERP experience to enhance core R/3 to meet the stringent and ever increasing demands from regulatory compliance/validation. The pre-configured solution with pre-defined validation package enables rapid deployment for a variety of business scenarios. When bundled with the Compliance Kit, it ensures the solution is maintained in a current and compliant state throughout its lifecycle. This leads to a high-level of reduction in the total cost of ownership.

Pharma Express^sm incorporates SAP Best Practices for the highly regulated pharmaceutical industry and seamlessly integrates key business processes used in the compliant manufacturing, sales and distribution of pharmaceuticals including contract management, chargebacks, order management, process manufacturing, quality management, inventory and financials. Version 2.0 enforces cGxP compliance including 21CFR Part 11 requirements and covers the following areas:

Enhanced and additional business scenarios will be available in the next, soon to be released, version of Pharma Express^sm and will be Powered by NetWeaver.

Application Deployment and Management

Pharma Express^sm is supported with a variety of deployment options tailored to meet customers’ business needs, budgets and preferences such as:

	Integrating a subsidiary to the parent company
	Integrating an acquired company with a parent company
	Phased global rollouts
	Simple extension for ERP deployment of newer applications.

The deployments methodology is achieved by the extensive use of business configuration sets (specifically designed by SAP for pharmaceutical industries) with Solution Manager as the dashboard. Companies can implement Pharma Express^sm in a standalone mode or in combination with the Compliance Kit. Companies can leverage Intelligroup’s hosting services where applications are hosted in a fully validated and state-of-the-art data center. Ongoing support and maintenance of applications are handled 24x7 from Intelligroup’s Global Center of Excellence.

With a host of complementary solutions and service offerings, Intelligroup will be able to address the various business needs from discovery through commercial manufacturing and distribution for a regulated environment in a life sciences industry. It provides a lower total cost of ownership without compromising on quality and compliance.

Pharma Express^sm Features

Process Manufacturing

	Pre-release status checks of components prior to controlled release
	Rule-based batch determination using dynamic batch selection criteria
	Material consumption reconciliation and lot history reporting
	Material quantity calculation with respect to active ingredient proportion
	Batch rework process
	Digital signatures with local verification and user-defined approval signature strategy to record process parameter results and usage decisions
	Support 21CFR Part 11 compliant processes for management of electronic batch records and digital signature recording and process instruction sheets (PI sheets)
	New product development

Active Ingredients Management

	Balancing component quantities to active ingredients
	User-defined, rule-based batch allocation process
	cGmP and validation compliant dynamic batch search procedures
	Batch management
	Dynamic batch selection criteria based on shelf life requirements, active ingredient content, FIFO, batch status and restricted use date
	Automatic restriction of batches that have a shelf life below the minimum requirements

Materials Management

	Inventory movements for returns to vendors from blocked stock, one step inter-plant transfer of blocked stock and inter-plant returns of blocked stock
	Ship-on-hold, and in-transit pallet and batch visibility for shipments between manufacturing and distribution locations

Quality Management

	Automatic inspection lot creation for reserve samples and stability samples
	Digital signatures with local verification for inspection plans and methods, sample drawing procedures, usage decisions and inspection results recording
	Sample stability inspection with lot audit trail
	Pipeline material inspection
	Manufacturing part control

Sales and Distribution

	DEA License Tracking
	Handling of Controlled Substances with Form 222 integration
	Batch Recall
	Contract Management
	Fully-integrated Chargeback solution with EDI
	Batch Determination
	Pallet ID Management
	Custom WMS Solutions

Product Genealogy

	Complete product lifecycle genealogy that includes lot tracking, disposition reporting and archiving, and closure
	Adheres to Good Manufacturing Practices (GMP)
	Lot traceability reporting and lot/batch usage, reconciliation and closure

Reporting/Interfaces

	Standard reports typically required for regulated manufacturing and distribution environments
	Ready to run EDI and ALE interfaces
	Interfaces to RF devices
	Interfaces to Best of Breed systems