Client Case Studies

Biopharmaceutical Company enhances productivity by implementing OPM suite and FDA validation

This customer is a biopharmaceutical company that discovers, develops, and intends to commercialize medicines for the treatment of serious medical conditions. They have product candidates in clinical trials for the potential treatment of cancer, rheumatoid arthritis, and eye disease. The Company is also a contract producer of commercial drug substances.

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Challenges

The life sciences industry is caught between pricing pressures and the ever increasing costs of drug discovery. The increased competitiveness along with higher regulatory hurdles are making it harder for companies to bring new drugs to market, safety issues are leading to product withdrawals. The greatest need at present is to escalate productivity that too cost-effectively.

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Solution

To ensure public health, federal regulations require all manufacturers to maintain secure and auditable trails of information pertaining to every phase of the development and manufacturing process. Built into the Oracle E-Business Suite is a framework that complies with the FDA’s 21 CFR Part 11 and cGMP regulations governing electronic records and e-signatures.

CTE implemented Oracle 11.5.9 with full FDA validation and Sarbannes-Oxley audit. Oracle Financials was already in place prior to the Process Manufacturing project. Some streamlining of the current Oracle Purchasing was done to facilitate the OPM installation.

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Benefits

• Streamlined process
• Enhanced productivity
• Reduced time to market

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