Solabs' GMP Compliance Portal Aids Merck Subsidiary FDA E-Submission Gateway Takes Form New Pharma-IT Products
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Salvatore Salamone
Senior IT Editor, Bio-IT World

Solabs' GMP Compliance Portal Aids Merck Subsidiary

Like many pharmaceutical organizations, Merck's United Kingdom-based subsidiary Merck Sharp & Dohme's primary manufacturing site has to maintain standard operating procedure (SOP) documents that spell out how it complies with U.S. FDA and European Union mandated current good manufacturing practices (cGMP).

And like so many other companies, MSD traditionally used signed paper masters of these documents. "SOPs are controlled documents," says Joanna Hills, site documentation specialist at MSD. "We were managing lots of hard copies, it was very time-consuming."

Read More . . .

FDA E-Submission Gateway Takes Form

In a move to simplify and standardize electronic submissions, the FDA this month selected GlobalNet Services Inc. and its partner Cyclone Commerce, for the FDA Electronic Submission Gateway project. Once completed, the gateway will provide a single, centralized point for the submission of new drug applications.

The project has an aggressive deployment schedule, with initial rollout set for June. At that time, companies will be able to securely submit new drug application documents for review and approval to the FDA's Center for Drug Evaluation and Research (CDER). They'll also be able to make submissions to other FDA centers, including the Center for Biologics Evaluation and Research (CBER) and the Office of Regulatory Affairs (ORA).

Read More . . .

Featured Events

Leverage Natural Products for Drug Development conference - February 28 - March 1, Philadelphia, PA

Beyond Genome 2005: The Future or Medicine - June 13-16, Fairmont Hotel, San Francisco, CA

Predicting Drug Safety and Risk - May 23-24, Boston, MA

IT Solutions for Drug Discovery at Bio-IT World Conference + Expo - May 17-19, Boston, MA

Best Practices Awards - Call for Entries - Deadline, April 15th

Would you like to see your conference or event listed here? Contact Shari Redan at shari_redan@bio-itworld.com for more information.

New Pharma-IT Products

MKS Inc. announced a new enterprise software change-management system, called the MKS Integrity Suite 2005. It integrates project management, compliance management, and decision support features, which are often only available using standalone systems, into a single suite. . .

Watchfire announced Watchfire WebXM 4.0, a new version of its risk management software that helps a company check whether its website meets a variety of government regulations. . .

Actio launched an opt-in Web-based service called Gatekeeper that manages requests, approvals, and purchases of chemicals and reagents. . .

Read More . . .

Links to Related Stories

Handheld Risks Prompt Push for Usage Policies

Pharmaceutical, Healthcare Firms Launch RFID Projects

Show Me the Value!

Planning and Scanning: Keys to Agile Project Management

Featured Events

Upcoming Industry Events

Leverage Natural Products for Drug Development conference - February 28 - March 1, Philadelphia, PA
http://www.cbinet.com/events/HB517/index.html
Attend CBI's Leverage Natural Products for Drug Development conference, February 28 - March 1, 2005 in Philadelphia, PA to better understand the value of natural products in the drug development process and methods for harnessing the opportunity they present. Special team discount rates are available. For more information or to register, please contact the Center for Business Intelligence toll free by phone at 1-800-817-8601 or via e-mail at cbireg@cbinet.com

Beyond Genome 2005: The Future or Medicine - June 13-16, Fairmont Hotel, San Francisco, CA.
This event Features programs on Bioinformatics, RNA Interference, Proteomics, Systems Biologym, and new to 2005 Genomic Variation. We anticipate more than 1,000 scientists and over 40 exhibiting companies. visit www.beyondgenome.com for more information.

Predicting Drug Safety and Risk - May 23-24, Boston, MA
CBI'Predicting Drug Safety and Risk - Actual Application of Systems-Based Omics Technologies in Reducing Attrition Rates and the Costs of Drug Discovery is designed to help companies to achieve this goal - to innovate and modernize drug safety tools and practices so that compounds may be screened more effectively and quickly in discovery as opposed to down the line when cost and risks are greater. For more information or to register, please contact the Center for Business Intelligence toll free at 1-800-817-8601 or via e-mail at cbireg@cbinet.com, or visit http://www.cbinet.com/events/HB533/index.html

IT SOLUTIONS FOR DRUG DISCOVERY CONFERENCE PROGRAM - featured at Bio-IT World Conference + Expo, May 17-19, Boston, MA
Register by April 1 with Priority Code: B0203 and SAVE!
http://www.bio-itworldexpo.com/live/26/events/26BOS05A/conference/CC881012
IT Solutions for Drug Discovery, a specialized conference program features a stunning assembly of speakers and thought leaders. Through presentations, case studies and panel discussions, attendees will learn about the latest in In silico and systems biology approaches to drug discovery, IT challenges in buildling the UK Biobank, databases for biomolecular information, advances in high-performance computing, including Blue Gene, and applications of the semantic web. Register Today: http://www.bio-itworldexpo.com/live/26/register

Bio-IT World Best Practices Awards - Call for Entries - Deadline April 15th
Enter the third annual Best Practices Awards recognizing the innovative use of technology and business strategies to accelerate the drug discovery and R&D process. Visit www.bio-itworld.com/bestpractices/ for more information.

Capgemini Analysis

Assessing Technology-Based Collaboration for Life Sciences

By Ian Brodie
Executive Consultant, Capgemini

Technology-based collaboration is one of the hottest topics in the life science industry today. There's pressure for organizations to support collaboration across their value chains - to collaborate with R&D partners, with customers, and suppliers.

The question is though, "Where's the real value?" In our experience, there is a huge disparity in the potential of different technology tools and application areas - and the trick at the moment is to discriminate between them.

In R&D, there is no doubting the trend toward collaboration. The scenario is familiar enough: with Big Pharma's product pipelines at historical lows, firms need to build relationships with biotech in particular, so developing collaboration is important.

Read More . . .

Capgemini Archives

Enterprise Contract Management

As the life sciences industry looks in vain for the next blockbuster to boost its finances, a potentially lucrative source of profit and revenue is staring many life sciences firms in the face. Read more.

Utilizing the Right Levers to Make Clinical Trials More Efficient

The latest generation of clinical trials data management systems is paving the way for pharma companies to conduct clinical trials in lower-cost countries while improving decision-making and increasing the quality and transparency of the data. Read more.

PLM Matters More Than Ever

Pharmaceutical companies are missing vital opportunities to maximize their products' lifetime value. Read more.

Meeting Mid-Tier Business Needs

Mid-tier pharma and biotech companies must achieve sustainable growth while maintaining regulatory compliance - the good news is that help is available. Read more.

Business Intelligence Helps Pharmas Work Smarter

A long-standing Holy Grail of IT, business intelligence, is re-emerging as one of the hottest IT topics. Read more.

Truly Mobile - Improving Pharma Sales Force Effectiveness

Investment in mobile technologies is growing at over 50 percent per annum across industries and around the world. It is one of the few clear IT growth areas. Interest from pharma companies is growing fast, too. Read more.

Improving the ROI of Your SAP Implementation

SAP's enterprise solution is ubiquitous - not least in the pharmaceutical industry, where its client list reads like a 'Who's Who' of industry leaders. But for some of these clients, SAP has not been the lifesaver they thought it would be. Read more.

Implementing RFID-Driven Electronic Product Codes Could Save You $100M a Year

Counterfeit products cost the U.S. industry in excess of $1 billion per year, representing as much as $50-$100 million in lost revenue per major pharmaceutical manufacturer. Read more.

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