•	Trusted Solutions for the Pharmaceutical Industry. (view)
•	Entrust/PKI: A security prescription.(view)
•	Promoting & protecting public health: 21 CFR Part 11. (view)
•	From inception to marketplace: secure document management. (view)
•	Secure remote access. (view)
•	Desktop security. (view)
•	Transitioning securely to the future. (view)
•	Benefits of Entrust/PKI. (view)

Trusted Solutions for the Pharmaceutical Industry (top)

Delaying a drug’s commercial availability even for a day can cost a pharmaceutical company millions of dollars. Which is why reducing time to market is critical to the success of companies in this highly competitive industry. Intense competition, regulatory compliance and complex business relationships with partners and suppliers are but a few of the main challenges facing today’s pharmaceutical companies. In response to these challenges, organizations are turning to new technologies to improve processes, increase efficiency — and reduce time to market.

Enterprises are taking advantage of technology to effectively share, store and transmit information electronically. While an electronic environment opens up tremendous business opportunities, it also brings up some very important issues with respect to the integrity and confidentiality of information.

Recent regulations brought into effect by the United States Food and Drug Administration (FDA) have established guidelines to govern the treatment and protection of electronic information within the industry. These rulings are driving pharmaceutical companies to re-examine their security policies and look seriously at building a sound security infrastructure to ensure regulatory compliance.

The Entrust® Technologies public-key infrastructure (PKI) provides a cohesive security model that comprehensively covers all enterprise security needs. The Entrust family of products provides pharmaceutical companies with an easy-to-use security framework that can form the foundation for regulatory compliance. Digital certificate technology, an integral part of the Entrust/PKI software products enables the use of certificate-based authentication for encryption and digital signatures.

Entrust/PKI: A security prescription (top)
Through its award-winning Entrust/PKI™ software, Entrust offersa comprehensive security solution to protect electronic information and transactions.

With Entrust/PKI in place, pharmaceutical companies can take advantage of a single security solution for all electronic communications. The use of open-standards allows Entrust/PKI to work with products from other vendors, and simplifies its integration into existing applications and networks.

Meeting enterprise security needs

Enterprise Resource Planning
Submitting new drug applications is one of the most mission-critical processes for pharmaceuticals and regulatory agencies. Since time to market and total quality management are crucial for success, the majority of pharmaceutical companies are increasingly deploying applications for Enterprise Resource Planning (ERP). ERP applications enable electronic transactions between internal business units and external supply chain business partners.

Promoting & protecting public health: 21 CFR Part 11  (top)
21 CFR Part 11, was brought into effect in August 1997 by the United States Food and Drug Administration (FDA) to govern the use of electronic records and electronic signatures within the pharmaceutical industry.

The focus of 21 CFR Part 11 is to specify the criteria that must be met for the FDA to consider electronic records, electronic signatures and hand written signatures executed to electronic records, as being trustworthy, reliable and generally equivalent to paper records and handwritten signatures on paper. Organizations that implement systems that meet these requirements will be able to use electronic records and electronic signatures and take advantage of the many benefits that accrue from moving to a paperless environment. Read about Entrust Technologies response to 21 CFR Part 11 (pdf - 444K)

Security plays an important role in mission-critical applications. Entrust works closely with leading ERP vendors, SAP™ and PeopleSoft™, to provide solutions which secure electronic data and establish trust between communi-cating parties using ERP applications.

Entrust Security Solutions for SAP R/3™ software is comprehensive, flexible, robust and scalable security for securing ERP transactions over intranets, extranets, and the Internet. By securing confidential data and establishing trust in the identity between communicating parties, the Entrust solution enables the increase in mission-critical transactions across business boundaries.

From inception to marketplace: secure document management (top)
If a drug is to successfully reach market, each step of the drug lifecycle must be carefully documented — everything from the idea phase, research and development, patent filing, trials, to final submission to the FDA. In most cases, the creation, storage and transmission of these documents is inextricably linked to the electronic world.

Realizing the importance of managing electronic documents effectively and securely, Entrust has formed a partner-ship with a leading supplier of enterprise document management products for the pharmaceutical industry. The partnership provides integrity, confidentiality and strong authentication of information as it passes over intranets, extranets and the Internet. Through the use of public-key encryption and digital signatures, Entrust/PKI secures sessions between users, browsers and servers. This ensures that the organization can securely extend the enterprise knowledge across public networks without fear of accessing a spoofed server — and that confidential information is safe from unauthorized users (e.g., the competition).

Secure remote access (top)
Having a secure, reliable and user-friendly remote access solution in place allows pharmaceutical companies with geographically dispersed locations and remote offices, to connect employees, wherever they may be.

Entrust has partnered with Check Point™ Software Technologies to provide an affordable secure remote access solution based on Entrust/PKI. Entrust/Access™ is a Virtual Private Network (VPN) solution that supports secure communications over unprotected public networks such as the Internet.

Secure e-mail (top)
Regulatory bodies, pharmaceutical companies and related enterprises use secure e-mail to exchange confidential records and to protect information that can be exchanged via e-mail. Secure e-mail is not only cost-effective and simple to use, but provides accountability since the e-mail can be digitally signed by the originator. Entrust has a broad portfolio of security solutions for a variety of e-mail products — either directly, or through industry partnerships.

For enterprises using Microsoft® and QUALCOMM® e-mail packages such as Microsoft® Exchange™, Microsoft® Outlook™ and QUALCOMM® Eudora Pro® on either PC and Macintosh® platforms, Entrust offers Entrust/Express™, a fully integrated and interoperable secure e-mail solution which enables users to encrypt and digitally sign e-mail messages.

Desktop security (top)
Each day, pharmaceutical companies deal with high volumes of information — the majority of it sensitive. This means that everything from research information to intellectual property is at risk to unauthorized access.

Entrust® Enterprise Desktop Suite™ provides cohesive security for desktop and laptop computers. Easy-to-use and flexible software transparently protects sensitive information throughout the wide range of activities performed daily on desktop computers. This comprehensive product suite provides file encryption, anti-virus protection upon decryption, secure e-mail and secure Web browsing.

Transitioning securely to the future (top)
Industry reform and competitive pressures are altering the way pharmaceuticals do business. The focus is changing as electronic processes and Internet-based communication replace paper — driving companies to look toward market-leading technology companies to help with the transition.

By partnering with Entrust, pharmaceutical companies can realize the benefits of a comprehensive security solution which integrates with legacy applications today and establishes the foundation for security solutions in the future.

Benefits of Entrust/PKI (top)

• A single security infrastructure across multiple applications and platforms reduces complexity and costs
• Single sign-on capabilities provide enhanced security while reducing overhead costs
• Investment protection through scalable, flexible software
• Increased savings and improved cash flow from a more aggressiveimplementation of electronic processing
• Greater efficiencies in inter-organization communication and processing of information