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PharmaSoft Newsletter, May 1996

Previous newsletters.

Trade shows 1996

PharmaSoft participates in two large trade shows during the spring and early summer. Both are arranged by DIA (Drug Information Association) and the participants are mainly from the pharmaceutical industry and drug regulatory authorities.

The DIA European trade show was held in the Bella Center in Copenhagen May 5th -7th. Every year the DIA arranges a world congress in the USA in association with its annual meeting which this year will be held in San Diego at the San Diego Convention Center. The congress will be June 9th through the 12th.

PharmaSoft´s presentation is dominated by DDM (Drug Dossier Manager), a system for document management in the pharmaceutical arena.

New Product

PharmaSoft is in the process of developing a new product database that adheres to the CEN standard (European Committee of Standardisation). This new product database will be included in all of PharmaSoft´s products, which will give them several advantages. A complete integration between the different product lines becomes possible. The transfer of information between industry and authorities is simplified. And our customers will be able to update their systems with new functions.

PharmaSoft´s new database is intended to be used in the areas of: classification of pharmaceutical products, pharmaceutical databases, knowledge databases, drug prescription, administrative and marketing routines, adverse reactions systems, pricing, etc.

The product is intended for both the pharmaceutical industry and regulatory authorities.

The Regulator User Forum in Dublin

PharmaSoft has developed the Regulator system to handle pharmaceutical information. Regulator previously was called Swedis. A number of national regulatory authorities, mostly in Europe, use Regulator. The last few years these national regulatory authorities have met in "The Regulator User Forum".

This years meeting took place in Dublin on April 18th and 19th, where the IMB (Irish Medicines Board) were the hosts. Regulator users from Sweden, Norway, Denmark, Iceland, Switzerland, Greece and Ireland attended. In addition guest speakers representing national regulatory authorities from Finland, England and Germany where invited.

At this meeting discussions where held concerning among other things the standardizing of product information, work routines, communication between authorities and the growing mountain of paper. As usual, our customers presented us with their needs, what possible improvements that could be made, what we at PharmaSoft should focus on and how we could be better, at the end of our meeting.

The crucial need for the standardization of pharmaceutical information, lead to the creation of a "Working Group". This group will co-operate with PharmaSoft in the development of the new product database that will be built upon current products and that will fulfill the European standards for pharmaceutical information. Member countries will complement with necessary functions and thereby set the standard for a new way to handle documentation and information at regulatory authorities.

The next Regulator User Forum will be in Copenhagen on November 14th to the 15th this year.

Internet services

More and more companies are deciding to expose themselves and their products on the Internet. It is as obvious today to be represented on the Internet as it is to be in the telephone book. The tool is the web page in the World Wide Web (WWW), the journalistic portion of the Internet. In the WWW you can present text, sound, pictures, graphics and even video information. You can even offer searching in your own databases and present the results. The information can be public or demand passwords for access. The information can be up dated as often as you like and when you like.

An important key to the Internet is the address you create for your web pages. The foundation for everything is your domain name which is your address built upon your company name. You create a web domain. On the Internet there are search engines in which your address is registered and the world can find your web page by using these engines.

By using PharmaSoft´s Internet service, our customers can present product information direct to the user. PharmaSoft has a solid knowledge of how to create, support, edit and connect web pages for companies and organizations. Because of our long experience in computer based pharmaceutical information we can help you with the management of a web domain and security is guaranteed because the database is kept on our Internet server.

ISO quality standards

Our work to create routines that cover PharmaSoft´s quality system is finished. This means that all development work now follow the routines that have been created to ensure adherence to ISO quality standards.

A first look of our quality system was conducted by a quality inspector from SIS (Standardization in Sweden) at the end of April. A pre-approval inspection will take place in the beginning of September.

Workflow and SGML

Document management is a dominate factor for the pharmaceutical industry and national regulatory agencies, and therefore even information technology must focus on this area. In the development of a new drug, t is unfortunately very common that a company spends a lot of time waiting or looking for a document, and this means delays in the processing of information. It is very important to keep track which documents are incomplete and when they will be finished. One solution is to increase efficiency by using workflow.

PharmaSoft has developed a prototype for a so called workflow. This application was created to improve workflow within an organization. Electronic and automatic management of workflow and company routines saves time and money.

A workflow is developed by considering the following:

What does the document flow look like?
What are our organizations rules and regulations?
Who are the people within the organization who have the correct access rights and knowledge?
The principles for directing workflow.
What is the established practice for the way we work within the organization?

The system focuses on the directing of work, the delivery of documents at the right time to the right person and the tracking of information by creating a history file. It is of great importance the workflow application even contains a warning function that calls attention to the fact that a document is delayed and must be taken care of to be completed in time, or that it has passed its deadline.

PharmaSoft is relying on the SGML standard in order to ensure future technology compatibility, and therefore is aking every effort to conform our products to this standard. We have in earlier newletters named SGML as a part of our PharmaEDI standard. PharmEDI contains different international standards pertaining to the development of software. SGML stands for Standard Generalized Markup Language and is an alternative to use, so that we may as accurate as possible describe information and to ensure easy conversion and exchange of information between different systems.

With SGML, you mark words or portions of text to better structure a document. HTML, which is used to create web pages on the Internet , is an application written according to SGML standard. If you were to look at a web page in the "raw" format you would see the different marking words that have been used. These marking words define how the text will be presented on the screen. SGML functions the same way.

How can SGML be useful?
One example is the application form that pharmaceutical companies must fill in for approval by the drug regulatory authorities. If these were to be defined in SGML, it would mean quicker handling for both the company and authorities. The transfer and re-use of information will be easier because the information can be distributed without consideration as to hardware and be presented in the different media forms.

Because documents are the objects that are moved in a workflow, SGML can be a big advantage when workflow is implemented. By using SGML you can circulate only the relevant portions of a document. In a workflow system it is only the most recent version of the document that is used. Automatic validation of the documents occurs at completion. Those parts of the document that have been circulated are compiled in the total SGML structure. SGML is also used to describe and document the workflow. This is so that in the future you will be able to see how a certain job was handled or in what situation the document was created.

The workflow application, as well as SGML, will be incorporated into DDM, PharmaSoft´s document management system. Workflow and SGML are also incorporated into Regulator, our system for drug regulatory authorities.

To receive more information concerning workflow, call or e-mail Ola Strandberg who is the responsible system developer for workflow, phone +46 18 185459. PharmaSoft´s SGML specialist is Christian Wallgren and he would be more than happy to give you more information concerning the SGML standard.
Phone +46 18 185452.

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August 1996.

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