Q: What are good business practices for outsourcing?

Wright: Best practices for an offshore outsourcing engagement include:

• Addressing intellectual property issues up front
• Defining clear service-level agreements
• Implementing non-disclosure agreements
• Identifying on-site and offshore project owners, process champions, and quality owners
• Recommending organizational changes, if needed
• Planning for employee issues
• Anticipating cultural differences
• Implementing good vendor governance processes
• Planning for disaster recovery and business continuity
• Doing up-front risk assessment
• Implementing robust change management
• Assuring physical and network security.

Wright: Planning for employee issues is a key priority of any outsourcing engagement. While there isn't enough space to address this issue here, up-front planning is necessary to minimize the impact of outsourcing on existing employees.

Q: What do regulatory agencies say about outsourcing?

Wright: This is probably the area of greatest concern for life sciences firms, but there really are no regulatory restrictions to using offshore facilities. If a company's validated system development and testing procedures meet FDA requirements, it really doesn't matter where the work is done as long as the correct procedures are rigorously followed.

Q: What about compliance with 21 CFR Part 11?

Wright: For IT solutions requiring 21 CFR Part 11 compliance, it's important to partner with an outsourcing provider with significant life sciences experience who has up-to-date regulatory experience and high-level certified processes. The vendor should not only know how to implement compliant systems but should be qualified to advise on the regulations. The same consideration applies to HIPAA and Sarbanes-Oxley regulations.

Q: Do you recommend that life sciences companies use IT offshoring?

Wright: Yes! And those who move first will achieve a significant competitive advantage. But vendor selection is critical. The key to success is local vendor staff with substantial domain experience. They should remain engaged in the project throughout and should be coupled with highly qualified offshore technical resources to lower the project cost.