“Strongly Recommended” and “Invaluable”: PIM and TVT

Monaco, March 2010. “To PIM or not to PIM?” That’s not the question. PIM (Product Information Management) will become the EMA-answer to long-standing, troublesome questions about product information and consistency. To get the answer right and ready as quickly as possible, a reliable text comparator like TVT (Text Verification Tool) from Schlafender Hase will play a crucial role.

At the PIM session on March 10, certain things became clear. PIM will become the standard for the future. During the Q&A session following the presentations, the debate about whether PIM would become “mandatory” or remain simply “strongly recommended” became a moot question. A high-ranking EMA spokesman left no doubt about the intent behind “strongly recommended”; “strongly recommended” means that by the end of 2012 there will be no alternative to PIM for Centrally Registered Products.

Lynsey Flitton, Senior Regulatory Labelling Manager, Pfizer, UK, also made it clear that achieving full implemation of PIM by the end of 2012 would be no easy task. In her presentation of “Practical Experiences of Migrations” during the pilot phase, she stressed how time-consuming the migration process was and how important it is to check the quality of all documents to be migrated. To date, she has worked on two products. In the first case she did not use a text verification tool, in the second case she did. Her recommendation to use a text verification tool could not be stronger: A tool such as TVT is simply “invaluable.”

Willie Schnaubelt, Managing Director at Schlafender Hase, put it another way: “TVT is already PIM ready and can play a key role in getting the entire industry PIM ready.”

For more Information contact:

Willie Schnaubelt
+49 69 2444-8112

or

Carsten Holinski
+49 69 2444-8115

SHP is doing a PIM training for one of its German customers.

From 8 to 10 March SHP exhibits during the 22nd Annual European DIA EuroMeeting in Monaco.
For some impressions of our booth please visit our EVENT section.

SHP participates the “Pharma-Day: Open Labeling and PIM Forum” from Logica in Munich, where all major “PIM players” met and got together . The event is very interesting and successful, again the audience were happy to meet us within this context.

SHP hosts a half-day-WebEx for one of its new global customers introducing TVT during a workshop for PIM.

SHP performs a training to one of the “big pharmas” in Basel, Switzerland.

SHP travels to Ireland to demo TVT to a pharma company.

SHP is hosting a WebEx to a pharmceutical company from Japan.

From 18 to 21 January SHP is doing a road-show through Switzerland to pharma- and non-pharma clients, the feedback is very positive.

SHP travels to Espo, Finland, to perform a two-day training to one of our customers.

Many things happen these two days: SHP passes succesfully a short-term audit by Wyeth, again we participate the SDL webniar “QRD PIM Data Migration” and another 2-day-training is performed in Melsungen, Germany.

Our partner from UK travels to New York to perform a training for one of our U.S.-customers.

SHP participates the SDL-Glemser seminar “Step-by-Step-Guide-to-PIM” which takes place at Hotel Lindner in Vienna.

SHP travels to Vienna to do a TVT presentation for Wyeth.

Because of lacking time, SHP is hosting 2 WebEx-presentations to new customers in Switzerland and Germany.

SHP starts with a series of telephone/WebEx trainings for BMS. Participants from more than 25 countries dial in to be trained.

SHP participates the event “Step-by-Step-Guide-to-PIM“ hosted by SDL and Extedo at the Rhein-Main-Airport in Frankfurt. Many participants were very happy to meet our team during this event.

Our partner in England hosts a WebEx training for Wyeth.

SHP hosts a 2-day-training in the Netherlands.

One of the European leading OTC-Pharma-Manufacturer hosts a WebEx for their affiliates in our Frankfurt office.

SHP participates the APV seminar “Risikomanagement bei der Einführung von computergesteuerten Kontrollsystemen für Druckversionen/bedruckte Packmittel” and is impressed of the contribution of other participants.

A second Webex takes place for Wyeth, focus again is using TVT with PIM files.

SHP participates the Concept-Heidelberg seminar “Printed Packaging Material” in Copenhagen, Denmark. By the way, we still recommend the Hotel Admiral.

SHP hosts an onsite-training for one of its customers in Switzerland.

SHP presents the benefits of TVT toward a global leading manufacturer of nutrition and ice-cream in Switzerland. The client is very impressed about the speed, userfriendlyness and accuracy of the TVT.

SHP is hosting a “train the trainer”-meeting for one of its customers in Germany.

Because of the stunning feedback SHP again participates the SDL-hosted webinar “QRD PIM Data Migration” to show how easy it is to compare PIM contents with the Text Verification Tool.

Wyeth HQ announces its interest in TVT for PIM migration and enters negotiations with us.

SHP travels to Ludwigshafen to host a TVT training for one of its clients.

SHP successfully passes the re-certification for its Quality Management System – DIN EN ISO 9001:2008 for the “Design and Softwaredevelopment for Regulated Environments”.

SHP travels to Brussels to participate the SDL Webinar “QRD PIM Data Migration” as a speaker and to show the audience how TVT can compare the contents of DOC and PDF files with the content of PIM files. The overall feedback of the audience is overwhelming.

The SHP team visits a local generica manufacturer to discuss pan-european usage of the Text Verification Tool.

Value of Text Verification Tool (TVT) Strongly Confirmed at RAPS in Philadelphia

Trying economic times mean tight budgets. More projects, fewer people, rigid quality standards and competitive pressures are making the computer-driven proofreading tool made by Schlafender Hase more valuable than ever.

Schlafender Hase GmbH of Frankfurt reported that an analysis of discussions with professionals attending the annually RAPS event (Regulatory Affairs Professionals Society) in Philadelphia showed they often spend more time doing what they can’t do than what they can do.

TVT shifts the focus from proofreading to pharmaceuticals

“Much of time-intensive proofreading activities in the regulatory affairs context have little to do with pharmaceuticals,” explained Willie Schnaubelt, managing director at Schlafender Hase. “Questions about misspelling and inconsistencies in layouts are robbing people of time that could be better spent on pharmaceutical issues. TVT makes it possible to win time for doing what they can do best, by not losing time doing proofreading chores that their computer can do more effectively.”

The human element was also a focal point at RAPS. While all agreed about the importance of flawless documentation, frustration was also expressed about the degree to which pharmaceutical skills often took a back seat to proofreading needs. As one RAPS visitor put it: “Sometimes I’m evaluated as a proofreader and not as a pharmaceuticals professional. It is an unfair situation, both to me and the product. I look to TVT as a way out of this dilemma.”

About TVT

TVT is the standard for the pharmaceutical industry. It supports all relevant file formats (DOC, DOCX RTF, TXT, HTML, PDF and both XML-standards PIM and SPL) and processes all major languages.

For more information about TVT and Schlafender Hase contact:

Willie Schnaubelt,
EU: +49 69 2444-8112
US: +1 973 685-6123

Text Verification Tool 5.0 from Schlafender Hase now supports all major languages of the world

Today, Schlafender Hase is proudly releasing the latest version of the Text Verification Tool.

The patent-protected Windows-application compares manuscript- against artwork-files, independent of the text-layout. Deviations are marked clearly and may be annotated for correction purposes.

8 out of 10 of the biggest pharmaceutical companies use the TVT

The software ensures that only the approved text is printed without any undesired deviations. Meanwhile, the TVT has almost become standard for labelling in the pharmaceutical industry.

Avoidance of product recalls

The Text Verification Tool supports the pharmaceutical industry in order to avoid deviations on the packaging material; consequentially only the initially approved text is printed.

Global XML Standards

In addition to DOC, RTF, TXT and PDF, TVT supports both XML-standards PIM and SPL, endorsed by the European and the U.S. regulatory authorities, EMEA and FDA.

World Language

TVT processes all major languages of the world having just included Thai, Hebrew and Arabic to the latest Version.

“By using the TVT, global products may be controlled outstandingly since we cover all global languages”, says Carsten Holinski, responsible for Sales and Training.

Safeguard against liability issues through character-to-character verification

“Though originally invented for labelling, nowadays other departments and industries like legal, communications and finance  use our software discovering  the strategic importance of TVT”, adds Andreas Raczek, Head of TVT-Development, and looks forward to ongoing discussions and presentations within the finance sector.

Download this press release as PDF.

For the first time, SHP travels to China to do a training to Novo Nordisk. In addition, other presentations and fruitful discussions with prospects and local affiliates take place. Again, the feedback is extremely positive. By the way, we recommend the Shangri-La Hotel in Beijing!

The validation of TVT 5.0 takes successfully place!

A 2-day-training for TVT is performed to one of our customers in Switzerland.

And another TVT presentation is done, given to a leading „specialty pharma company“, headquartered in Sweden.

Dr. Falk in Freiburg receives a TVT presentation and Frank Hessler, Managing Director of SHP, is disappointed that we took the car, and not the private plane. Next time, Frank, we promise and look forward to it!

Roche invites us to come to Basel to do a TVT presentation, the german affiliate is participating, too.

A top-ten-generics company located in Germany receives a 4-day- training for TVT. Together with SAP our application is implemented directly into the workflow tools to serve best the customer’s needs.

Article and Ad on Text Verification Tool in the "World Pharma".

See our article on page 45 in the online issue.

SHP is doing an update presentation to 5.0 to Novo Nordisk, on of the very first global TVT customers.

SHP provides very first beta-licenses of the new TVT 5.0 to participating customers. This version of TVT supports Hebrew, Arabic and Thai, and therefore covers all major languages of the world.

And another WebEx hosted by SHP is given to a pharmaceutical company headquartered in Israel.

SHP joins the DIA Europe, which took place March 23 to 25. Again we receive a lot of positive feedback and catch up the dialogue with regulatory authorities.

During a meeting with a customer, a famous software company specialised in work-flow management and collection of financial data becomes aware of TVT and receive a presentation. They are enthusiastic and look forward to a future cooperation.

TVT is presented again to a daughter company of Merck in Hamburg with focus on hypoallergenic.

With one of its first global TVT-customers SHP was doing a web conference to plan the global roll-out and update of the next version of TVT, 5.0

The world leader in industrial precious metals and special metals receives a TVT presentation, and is excited about the strategic value of our tool.

Another TVT presentation is done to a German pharmaceutical company in Munich.

Three ongoing „super users“ from Novo Nordisk come for 3 days to Frankfurt to receive an intensive training of TVT. The training takes place in our premises.

The SHP team flies out to Hamburg, presenting TVT to the German affiliate of a Sweden headquartered pharma company.

The SHP team flies to Leipzig to do a presentation to a pharma company in Brehna.

We get a visit from a major Generica company to discuss the follow up and european roll out of TVT for their company.

A global customer purchased another 12 licenses for its affiliates in Asia.

Schlafender Hase GmbH hosts a 4-h-webconference for all european affiliates of a major pharma player, and enters a very positive and constructive dialogue with this new global customer.

A 1-day-TVT-training was performed to a new pharma customer located in Bad Homburg.

A TVT-presentation was given to a German biotech-company.