Information Management Systems Enable Manufacturing Facilities to Ramp Up Productivity - Reporting requirements and safety regulations make reliable IT systems a high priority at the manufacturing lev

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Information Management Systems Enable Manufacturing Facilities to Ramp Up Productivity
Reporting requirements and safety regulations make reliable IT systems a high priority at the manufacturing level.


BioPharm International


EBR and PAT applications offer enormous benefits to pharma companies. As regulations grow more complex, reporting more demanding, and markets more volatile, plant-level IT needs to give their pharma companies new measures of flexibility to improve efficiency and hem in costs.14 Companies need continuous availability to make these applications deliver their business value, but they shouldn't be worrying about providing the required high availability. High availability is its own competence, with its own specialists. Better to use them as a cost-effective and reliable solution than try to grow internal capabilities that takes time and money, with the high potential that they can easily move to a competitor.

Dave Femia is the director of the life science practice at Stratus Technologies 111 Powdermill Rd., Maynard, MA. 61754, (978).461.7000.

REFERENCES

1. DePalma, A,"In Search of Consistency," http://pharmamanufacturing.com/ 03/18/2003, http:// http://www.pharmamanufacturing.com/articles/2003/71.html.

2. "Quality by Design: A Challenge to the Pharma Industry," http://www.fda.gov/ohrms/dockets/ac/02/briefing/3869B1_07_Camp.ppt, CAMP Member Companies March 2002

3. "Continuous Quality Assurance for Improved Business & Process Performance in Pharmaceuticals (Proceedings)," IQPC, London, 7/1/2005.

4. "Continuous Quality Assurance for Improved Business & Process Performance in Pharmaceuticals (Proceedings)," IQPC, London, 7/1/2005.

5. "Continuous Quality Assurance for Improved Business & Process Performance in Pharmaceuticals (Proceedings)," IQPC, London, 7/1/2005.

6. Bartholomew, D, "MES Goes Prime Time," http://pharmamanufacturing.com/, 10/20/2004 http:// http://www.pharmamanufacturing.com/articles/2004/225.html.

7. Martin, R,"Pharmaceutical and Life Sciences Industry Outlook: Growth and Efficiency Enabled by Demand-Driven Supply Networks," AMR, 9/17/2004.

8. "Continuous Quality Assurance for Improved Business & Process Performance in Pharmaceuticals (Proceedings)," IQPC, London, 7/1/2005

9. "Best Practices for Continuous Application Availability," Donna Scott, Gartner, 12/2/2004, Data Center Conference.

10. Pharmaceutical cGMPs for the 21st Century — A Risk-Based Approach, Final Report, Fall 2004. http:// http://www.fda.gov/cder/gmp/gmp2004/GMP_finalreport2004.htm

11. "ICH Q9, Note for Guidance Quality Risk Management" (draft), European Medicines Agency, May 2005.

12. "A Risk-Based Approach to Compliant Electronic Records and Signatures," ISPE/GAMP, February 2005

13. "GAMP Guide for Validation of Automated Systems, GAMP4," ISPE/GAMP, December 2001.

14. Larson, K,"Changing Pharmaceutical Industry Must Leverage Manufacturing IT," http://pharmamanufacturing.com/, 12/31/2003 http:// http://www.pharmamanufacturing.com/articles/2004/197.html.


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