Documentation challenges are undermining Pharma OpEx programs

In recent years competitive pressures in the pharmaceutical industry have caused many companies to focus on increasing profitability by implementing Operational Excellence (OpEx) programs.

Although the OpEx approach to continuous improvement holds great potential for pharmaceutical manufacturers, many struggle to realize its full benefits. The quality and consistency of documentation is a common cause of problems throughout the industry. 

In this paper we

• examine areas where documentation-related problems arise, and
• suggest how companies can solve these problems.

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