Schlafender HaseSOFTWARE & COMMUNICATIONS
Schlafender Hase Software and Communications
Text Verification Tool

Features & Facts

System Requirements

Windows Vista/7/8/8.1 and MS Word 2007/2010/2013

CPU of 1 GHz, 1GB RAM, 32bit color depth, 1 GB disc space.

To include comments and remarks within the PDF file you do not need Adobe Acrobat, the annotations function is included in the TVT.

You can also use the software via the internet as online-service.

Product Technology

The TVT supports XML, TXT, RTF, original Adobe PDF and DOC formats. The TVT directly supports the accepted international standard and safest method available on the market by implementing the original Adobe PDF libraries. The TVT also fully supports the most current version of the XML standard endorsed by the FDA (SPL). No additional Adobe products are required on the workstation, so there are no additional costs. The TVT supports the comparison of RTF and PDF files without prior conversion to another format: the TVT does not convert the original document to a PDF format prior to inspection. In this way TVT ensures the data integrity needed to meet all compliance requirements in any highly regulated environment.

Word files (DOC, DOCX) can also be compared if MS Word is installed on the workstation.

Can inspect text in all major languages

The TVT supports all documents with Unicode standard fonts or the AGL in languages, whether written from left to right or right to left. Fonts/languages such as Greek, Russian, etc. are fully supported as well as Asian languages (e.g. Chinese, Japanese, Korean). There is a special setting that allows easy handling of complex languages such as Thai, and languages written right to left such as Arabic and Hebrew. TVT can also compare text written in Braille. All of these features are a standard part of the TVT: there is no need to buy additional modules – at additional cost.

Large documents (e.g. submissions)

The TVT compares large documents (DOC, RTF or PDF) in seconds
(e.g. 150 pages in 15 seconds on a standard PC).

Multiple documents

The TVT can compare several original manuscripts with one artwork in a single step and vice versa. This feature is very useful for leaflets or manuals that contain text in different languages.

Reports

Creating a report with the TVT is as easy and quick as a click. The report contains all the information needed to ensure a complete and easy-to-read audit trail: project name, what project settings were used, who worked on the project, when, what deviations were identified, and what actions were taken to correct the deviations.

Reports can be customized to perfectly meet the customer's needs – with as much information as necessary and as little as desired. The report is a PDF that can be printed out or saved as digital copy: it focuses on greater quality, increased responsibility – and provides necessary compliance documentation.

User-friendliness

The TVT was developed to meet a real customer need: it was designed with the user for the user. Although user-friendliness is subjective, the feedback from our customers is highly positive. TVT uses the familiar Microsoft environment and genuine Adobe PDF files: most users already know much of what they need to start working effectively with the TVT. Additional training quickly turns novice users into experts. Deviations are marked clearly, annotations can be generated automatically, detailed reports are as easy as a click, ensuring total compliance.

Validation

The TVT has been validated and validation documentation and execution are available if required. Most of our pharmaceutical customers have validated the Text Verification Tool successfully according to standards such as GxP, GAMP 5, etc.

21 CFR Part 11 & FDA Compliant

The TVT complies fully with all Code of Federal Regulations (CFR) 21 Part 11 as required by the FDA. The TVT fits perfectly into any QM System by using the Windows OS security.

With a simple click the TVT report function creates comprehensive audit trail that documents all aspects oft the project: what documents were checked by whom with which settings, when, what deviations were found, what actions were taken; it also includes any annotations made by users. The report is generated as an Adobe PDF and can be easily printed out or stored electronically.

Partial Text Inspection

In many cases a user may not want or need to inspect the entire text. The TVT has a special exclude function that allows the user to mark and exclude all parts of the text that are not relevant for the inspection (for example, printer's information, page numbers, etc.) The user can focus only on those parts he wants to focus on.

Save your work

Proofreaders often have multiple duties and have to interrupt the proofreading process to attend to other assignments. The TVT allows you to save your work at any time. When you are ready to resume proofreading you can simply pick up where you left of – without losing a step.

International Support

SHP offers worldwide support – 1st, 2nd and/or 3rd level, depending on the customer's needs and wishes. Support is coordinated at our headquarters in Germany and is available either via email, telephone, web, or if required, by customer visit – in English, French, German or Spanish.

SHP recommends a support contract, which also entitles the user to receive all updates at no extra charge.

Training

SHP offers worldwide on-site training as well as corporate and web training in English, French, German or Spanish. We also offer in-house training at our headquarters in Frankfurt, Germany.

Pharmaceutical Experience

The founders of SHP have been working closely with the pharmaceutical industry for more than a decade.

SHP was founded in 2001. In 2003 a large pharmaceutical challenged SHP to find an effective way to solve its proofreading problems. SHP met the challenge with the first version of the TVT and the rest is history. The TVT was launched in 2004. Changing customer's needs have continually led to new features; in the beginning of 2014 SHP launched TVT7.0. The TVT has come to be considered the industry standard and is currently used by all of the world's top ten pharmaceutical companies and more than 120 pharmaceutical companies worldwide.

Customer Base

Our business is customer-driven. We strive to know and meet our customers' needs. But we don't just work for and with our customers – we also learn from them. They have helped us gain practical experience in all aspects of the proofreading and printing process. Our customer base is large and diverse. The TVT is most valuable in highly regulated environments; our customers come from different industries, with the highly regulated pharmaceutical industry being a main focus. Customers range from small pharmaceutical companies with only 50 employees at a single location to truly global organizations with as many as 100,000 employees worldwide.

Software Development Procedures

TVT is GxP and GAMP 5 compliant. A full audit trail ensures quality standards are met, such as CFR 21 Part 11.

ISO Certified

SHP is the proud owner of an ISO 9001:2008 certificate, granted for the "Design and Development of Software for Regulated Environments".

The TVT is developed under GAMP5 conditions and SHP has been audited successfully by pharmaceutical companies for compliance with their quality standards and GAMP5.

Spell check and medical dictionary

The TVT includes neither a spell check function nor a medical dictionary – and there is a good reason for this. In highly regulated environments it is essential that a comparison tool preserve the integrity of the files being compared. The original document has been written, reviewed and approved by experts before it enters the comparison process. For quality reasons, spell checks – and, of course all content checks – should be conducted before the document enters the comparison process. A document that has not been checked for spelling cannot really be "approved". Similarly, any need to consult, for example, a medical dictionary at this point casts doubt on the integrity of the "approved" document.

Price

The TVT is available in three basic ways: as a machine-based license, as a concurrent license, or as TVTaaS via Internet. The price depends on the number of licenses and, in the case of concurrent licenses, on the number of users. A rebate is offered for large orders.

Languages

TVT supports all of the world's major languages, including complex languages, (e.g. Thai, Hebrew and Arabic) and Braille.

File Types

TVT supports all standard file types including SPL, the FDA standard file: DOC, DOCX, RTF, TXT, HTML, PDF and SPL.

Data Integrity / Compliance / Quality Management

Your files are not changed at any point in the comparison process. The TVT is compliant with CFR 21 Part 11 fits perfectly into any QM System by using the Windows OS security. The report function ensures a comprehensive audit trail that documents all steps taken during a given inspection: the user, date and time, deviations found, actions taken, annotations made. The report can be printed out or saved as a digital copy.

Genuine Adobe PDF Libraries

For quality reasons, the TVT uses only genuine Adobe PDF libraries.

ISO Certified

TVT is ISO certified (DIN EN ISO 9001:2008) for the "Design and Software Development for Regulated Environments".

Support & services

To give your TVT-users a special incentive, you can send them to our headquarters in Frankfurt where they can become "super-users of the Text Verification Tool. After in-depth customized training in Frankfurt they can return to spread their expert knowledge within your company. We also offer "quick tutorials" as well as train-the-trainer sessions and training for regular users.

Some of our customers   > read more