The Pharmaceutical industry discovers, develops, produces, and markets drugs or pharmaceutical drugs for use as medications to be administered (or self-administered) to patients, with the aim to cure them, vaccinate them, or alleviate the symptoms. Pharmaceutical companies may deal in generic or brand medications and medical devices. They are subject to a variety of laws and regulations that govern the patenting,testing, safety, efficacy and marketing of drugs.
Profile #1
Requirement
The Legacy applications functionality of Product Management with streamlined Change Management approval process. There were 4 different application was holding the above functionality. The Material management based on different rules with the variant management was custom available needs to be fitted into PLM system.
Consulting
Oracle Agile PLM was the proposed product of Product Collaboration and Product Portfolio Management features was able to handle the functionality. Predominantly configuration approach was taken however customization was also introduced to achieve the functionality for business automation which reduced lot of efforts. The turn around time was reduced to 70% from the existing approach. The GxP process was followed for the Implementation
Profile #2
Requirement
This project required the Installation and Operational Qualification of implementation which has been based on the business requirements. The Functional Test cases and System Integration Test cases design and development was the ask from the Business. The Validator framework was expectation which needs to be fool proof for the functionality from the Business.
Consulting
Installation and Qualification of Development, Test, QA and Production Environment was handled by the team. The Operational Qualification of the implemented system was driven from the User Requirement Document and all the scenarios was analysed and drafted. All the probable Operational Qualification scenarios were listed down and signed off from the business. Based on the scenarios all the execution of test cases resulted in robust system for end users. The GxP process was followed for the Implementation
Profile #3
Requirement
This client wanted document management system which closely associated with the product components. The document varies from procedure of instruction, standard operating procedure, device information and part details. This shall be improvised by the revision management of the documents and parts.
Consulting
Oracle Agile PLM Product Collaboration module was implemented for this requirement where we have Documents are managed with the Change Management with the approval process and linking to the corresponding Part information. Once the revised document is published to the ERP system for the manufacturing downstream. The GxP process was followed for the Implementation
