February 11, 2012
| Bio-IT World > Regulatory Compliance


Regulatory Compliance


STRATEGIC INSIGHTS

Regulatory Compliance

Introduction

BY ANTHONY STRATTNER 

Strategic Insights 
· Introduction
· PDMA Compliance in 12 Steps
· What's the Problem?
· Systematize Your Regulatory Info!
· The Quality System Edge
Process integration isn't just good insurance.
By Lisa Griffith
January 12, 2004 | Since the year 2000, drug companies have been charged with more than $2.5 billion in fines by the U.S. government. Many of these fines have been for deliberate drug-pricing fraud, but many others were for regulatory noncompliance post facto. Once a drug company becomes the target for litigation, and comprehensive compliance documentation fails to materialize, the feds assume negligence.

Moreover, senior managers no longer get a pass by claiming that they didn't know what was happening in their companies. That's only fitting because, as the first story in this special report points out, compliance programs must have total buy-in and oversight from top management to be effective. The mere existence of a program is no guarantee it will work. Culture trumps technology every time.



PDMA Compliance in 12 Steps 








White Papers & Special Reports

sgi whp 2
Managing the Modern Genomics Data Flood
Sponsored by SGI

Managing and storing the perfect storm of multi-disciplined data pouring from next generation sequencers and other omics instruments is a central challenge in life sciences. Discover in this paper how the SGI ArcFiniti storage solution, optimized for unstructured genomics and life sciences data can: 

  • Reduce costs, proactively protect data integrity, and deliver the high performance I/O required for genomics data processing and analysis.  
  • Effectively manage capacities from 156TB to 1.4PB as a disk based, integrated hardware and software platform 


sgi - whp 1
Turning Genomics Data into Practical Insight
Sponsored by SGI

With worldwide sequencing capacity approaching 13 quadrillion DNA bases annually turning genomics data into knowledge is a true computational challenge. Read this paper and learn how the SGI UV coherent shared memory platform can:  

  • Speed results time while cost competitively tackling the most difficult computational problems across all omics disciplines. 
  • Push performance by scaling to extraordinary levels, up to 256 sockets (2,560 cores, 4,096 threads) per single system (one OS image). 

Provide support for up to 16TB of coherent shared memory in a single system image enabling extreme efficiency across a wide range of compute demands. 



accerlys-logo_2012_wh
New Complimentary Market Survey…
Collaborations and Communications Within Drug Discovery Research
Sponsored by Accelrys
This survey was conducted by the Cambridge Healthtech Media Group in January, 2012. It was sponsored by Accelrys related to their HEOS initiative to gather valid information around externalizing collaborative research while improving communications in the cloud. With 310 qualified industry respondents the survey findings reveal useful usage and trends patterns.  An insightful follow-on discussion and webinar related to this survey, and the HEOS by Scynexis SaaS portal is also available on the Bio-IT World website for complementary viewing.
 


Job Openings

tessella logo 
Scientific Software Engineer
Boston MA
$70,000 to $95,000
 
Apply at http://jobs.tessella.com   

oxford nanopore logo 


Early Access Collaborations ManagersClick here to find out more and apply   

Oxford Nanopore's GridION technology, VP, Sales and Marketing Click to  Apply  

For reprints and/or copyright permission, please contact  Tim McLucas, (781) 972-1342, tmclucas@healthtech.com .