The PMC Suite technology can replace paper-based systems and outdated and/or fragmented electronic systems with an effi cient electronic envi- ronment supporting “science to compliance.” According to data presented at several Accelrys user group conferences, the single-platform PMC Suite allows for the following key benefi ts8


:


• Up to 25% improvement in productivity • 50% reduction in cycle time • Signifi cant reductions in regulatory compliance risk.


Other benefi ts include improved knowledge management, data mining, and technology transfer among the various domains, including R&D, manufacturing, and commercialization; adherence to QbD initiatives; and an overall faster time to market.


References 1. Forbes. The truly staggering cost of inventing new drugs. http://www. forbes.com/sites/matthewherper/2012/02/10/the-truly-staggering- cost-of-inventing-new-drugs/


2. MedicineNet.com. Drug approvals—from invention to market… a 12-year trip. http://www.medicinenet.com/script/main/art. asp?articlekey=9877


3. International Conference on Harmonisation. Pharmaceutical Quality System Q10. 2008. http://www.fda.gov/downloads/Drugs/Guidances/ ucm073517.pdf


4. Singh, A.; Aggarwal, G. Technology transfer in pharmaceutical indus- try: a discussion. Int. J. Pharma . Bio Sci. 2010, 1, 3.


5. Scholten, B. Integrating ISA-88 and ISA-95. http://www.isa-95.com/ subpages/technology/techdes/isa-88_and_isa-95.php


6. Power, M.; Wlodarczyk P. Process defi nition management: using ISA- 88 and BatchML as a basis for Process Defi nitions and Recipe Normal- ization. Presented at the WBF European Conference. Nov 10–13, 2008; Barcelona, Spain.


7. U.S. Food and Drug Administration. Part 11, electronic records; elec- tronic signatures—scope and application. http://www.fda.gov/ regulatoryinformation/guidances/ucm125067.htm


8. 2012 IMACS in Review, 8th Annual IMACS at 2012 Accelrys User Group Meeting—May 7–9, 2012, Boston, MA; 2013 PMC Suite User Confer- ence: In Review—June 4-5, 2013, Princeton, NJ.


Daniela Jansen, Ph.D., is Product Marketing Manager, BIOVIA, Dassault Systèmes, Vélizy, France (previously Accelrys); e-mail: Daniela.jansen@3ds. com; www.3ds.com/products-services/biovia


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