In the pharmaceutical business model, a company stores its intellectual capital that is critical to its competitive advantage, in-house. Vital company data travels between manufacturers, wholesalers, and retailers, mostly through web-based collaboration tools and communication channels via the internet.

Due to the present competitive environment, intellectual property (IP) protection is a major concern for pharmaceutical and biotechnology organizations of all sizes. Incidents of industrial espionage and employees defecting to a competitor and taking sensitive information with them, has forced companies within the industry to rethink their data security processes. Pharma risks continue to deepen with emerging technologies that provide access to company data, most of them being web-based.

Regular security procedures and regulations don’t measure up to completely securing a pharmaceutical company’s IT systems, and thus put the company’s trade secrets and clinical trials, as well as employee and customer information at risk. Protecting one of the most important assets of the business is a key driver for data loss prevention efforts.

Another reason is that the worldwide Pharmaceutical industry is tightly regulated by the U.S. Federal Drug Administration (FDA), and therefore must ensure strict standards are maintained at every stage. This is due to the fact that loss of valuable data from pharmaceutical companies may lead to millions of dollars in lost revenue and loss of market share.

The pharmaceutical industry is subject to a number of regulations set by the Food and Drug Administration (FDA) and other regulatory bodies. These policies impose stringent quality standards that pharmaceutical companies need to adhere to. Quality management in the industry goes beyond ISO expectations and is much more complex and pervasive in scope necessitating significant investment of time, effort and resources. Faced with the challenge of meeting complex FDA regulations, pharmaceutical companies are investing substantial resources in the development and implementation of strategies that make them compliant.

The Title 21 CFR Part 11 is a regulation which primarily focuses on pharmaceutical and other industries controlled by the Food and Drug Administration (FDA). It defines the criteria under which electronic records and electronic signatures are considered to be trustworthy, reliable and equivalent to paper records.

Pharmaceutical manufacturers need to comply with such government regulations; define custom lexicons to enforce corporate policies that protect intellectual property, regulatory reports, and clinical trial information; and ensure the confidentiality of outbound data files.

Pawaa Software has addressed the above issues faced by the pharmaceutical industry, with the introduction of its patented innovations – pawaaWEBB and pawaaFILE.

PawaaWEBB is a powerful data protection software that helps the pharmaceutical industry to successfully secure their online data. The software goes beyond traditional authentication and access controls, and provides complete visibility into users’ behavior regarding how confidential and sensitive information is handled.

By using pawaaWEBB, companies can enforce the same IT and security policies on both managed and unmanaged computers, whether they are within or outside the network, thus ensuring uniform security. The user can only visit the URLs that are permitted by the policy. Also hardware such as USB, Bluetooth, CD/DVD are safeguarded so that data leaks cannot be created while in the session.

Detailed logs follow the user’s activities such as applications launched during the pawaaWEBB session, clipboard activities, screenshots, bandwidth usage, print, URL clicks, etc. These are sent back to the server for audit trails, forensic analysis and report generation. Apart from monitoring and controlling user activities and the computer hardware, pawaaWEBB can also mask certain parts of the web pages for certain user groups without having to modify the back end applications and database.

PawaaFILE is a patented Intelligent File Format which is completely secure and addresses some of the basic security issues that exists with the normal file format. It fills several security gaps including the safety and control of the files downloaded from the web and the reports generated from web applications. Any file downloaded or reports generated from pawaaWEBB are automatically converted to the pawaaFILE format.

PawaaFILE provides the pharmaceutical industry complete control over files through its Information Rights Management policies. The policy maker of the company decides who can create the pawaaFILE, from which application, where it can be circulated, what type of authentication mechanism is required to consume the file, when it expires, Information Rights Management policies such as print, save as, edit, screenshot, time bound policies, and much more. So when a pawaaFILE leaves the organization accidentally or maliciously, it is of no use to unintended users outside the organization, or outside the organization's network, based on the policy. Only intended users can use the file, for the time allowed as defined in the policy.

The format of the pawaaFILE requires up to three keys to open the file, making it literally impossible for the hackers to break into it.

The combination of pawaaWEBB and pawaaFILE makes a powerful data leak prevention solution. Together they offer the pharmaceutical and biotechnology industry an extremely high level of web and file security, while ensuring that the solution is practically usable. They also help organizations in being compliant with industry regulations.

The pharma industry develops, manufactures, sells and distributes billions of dollars of drugs every year. Companies also maintain personal information on employees and clinical trial participants, which is a valuable commodity for identity thieves. Common incidents like a stolen laptop, can lead to costly losses, as thieves seek any opportunity to seize classified and proprietary information. To prevent this from happening, a complete audit trail is required, in addition to visibility on who is accessing the information and how the information is being handled. The files downloaded and reports generated from these applications should only be used by intended users, hence preventing any types of data leaks and compliance violations. Through this powerful combination, pharma companies can now,

PawaaWEBB and pawaaFILE help pharmaceutical and biotechnology companies secure their data without having to make major changes to their IT infrastructure or applications. Together they offer complete control, protection and freedom. Control over user behavior, Protection from data leaks and Freedom to enforce policies without privacy violations.