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Oracle Implementation at a Manufacturing Facility

Overview

The world's largest fully integrated plasma collection company, the client is a world leader in the therapeutic protein industry. It distributes products to over three-quarters of the world's markets and produces nearly one-fifth of the world's plasma-based therapies. The client maintains complete control over the product cycle to ensure quality, purity and safety of its therapies. Research and development activities form a major part of the client's operations.

Business need

Healthcare industry perhaps faces the most stringent process control regulations and compounding the situation further are the complex processes involved in product cycle and R&D. The client enterprise needed a system to manage its information and research data efficiently while enabling generation of reports related to deviation, Corrective And Preventive Action (CAPA), etc during the product cycle and for its R&D processes.

The company partnered with Infosys to implement a product release and deviation tracking system. Initially executed for one of the manufacturing facilities of the company, the solution was later to be rolled out in other facilities. Infosys decided to implement the relational database -- Oracle8i.

The challenges

The sheer number of processes involved and the need to keep track of each one of them presented numerous challenges:

The rudimentary system of the client included many manual procedures resulting in a large number of human errors.
The complex and large number of iterations preceding the rollout of a finished product meant extensive documentation.
Apart from deviations, many other sub-processes such as compliance requirements needed to be tracked.
The regulatory requirements warranted a multi-layer record keeping system complicating report generation.
The system was also required to be compliant with FDA’s 21 CFR part 11 guidelines for electronic records and signatures.
Given the enormous data and its sensitive nature, a multi-layered security system was imperative to give the client a tight access control to avoid discrepancies.

Infosys' Role

The Infosys team consisted of business consultants from the healthcare domain who had extensive experience in relational database management. The program was managed using Infosys' Global Delivery Model (GDM).

The client was using a FoxPro system to help keep track of deviations, which lacked scalability and failed to cater to the increasing requirements of the client. Infosys decided to replace it with Oracle8i relational database package. Infosys partnered with the client to:

Implement an efficient product release and deviation tracking system
Address the quality and security requirements

Keeping in mind the client's requirement to handle large amounts of information, Infosys proposed to use a two-tier client-server architecture -- Oracle8i for the database and Developer for client forms/reports. All meta-data regarding the database structure as well as the form structure was stored using Designer6i repository.

Benefits

Infosys' proprietary Global Delivery Model (GDM) resulted in almost 40 percent reduction in cost of ownership for the client besides giving the client on-time delivery and a high quality solution.
The system enabled the execution of a new robust business process.
CAPA documentation and workflows with separate business rules for manufacturing and R&D incidents enabled easy generation of standard and ad-hoc reports.
The client achieved compliance with FDA's 21 CFR Part 11 regulations for a closed system.
The system put in place an elaborate access control and system security.
The new system minimized manual processes facilitating easy and error-free information management.
A traceability matrix that links user and functional requirements, functional test plans and test reports was put in place for client's future requirements.
Infosys enabled the client to document its system development as per cGMP requirements.

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