Product Technology (Direct support for multiple file formats)
Supports XML, TXT, RTF, original Adobe PDF and DOC formatsThe 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 two XML standards endorsed by the FDA (SPL) and the EMEA (PIM).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 – which would be beyond the pale in a validated environment.
The TVT preserves the integrity of the approved document by not converting the original document to PDF format prior to inspection.
Word files (DOC) can also be compared if MS Word is installed on the workstation.
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Can inspect text in any language
All documents with Unicode standard fonts or the AGL in languages written from left to right are supported at no extra charge (no additional modules or costs).
Fonts/languages such as Greek, Russian, etc. are fully supported as well as Asian languages (e.g. Chinese, Japanese, Korean).
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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).
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Multiple documents
The TVT can compare many 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.
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Reports
The reports can be customized. They contain as much information as necessary and as little as desired (from the point of view of the client, not the programmer) – so they suit the client’s needs perfectly.
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Ease-of-Use (Interface)
Although this is subjective, the feedback from our customers is “Yes”, they like and appreciate the user-friendly Text Verification Tool.
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Validation
Validation documentation and execution are available if required since the TVT has been validated. Most of our pharmaceutical customers have validated the Text Verification Tool successfully according to standards such as GxP, GAMP, etc.
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21 CFR Part 11 & FDA Compliant
The TVT is compliant with CFR 21 Part 11; it does not contravene this FDA provision in any way.
The TVT fits perfectly into any QM System by using the Windows OS security.
An audit trail that documents the user, date and time is added to the report as well as to the annotations in the PDF output.
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Partial Text Inspection
The TVT has the ability to conduct a partial inspection of documents, including the ability to exclude parts or whole pages.
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Save your work
TVT allows you to save your work at any time. Colleagues can also continue the proofreading process from the point at which it has been saved.
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International Support
The worldwide support (1st, 2nd and/or 3rd level as required) is based in Germany and is available either via email, telephone, web, or if required by customer visit – in English, French or German.
SHP recommends a support contract, which also entitles the user to receive updates at no extra charge.
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Training
SHP offers worldwide on-site training as well as corporate and web training in German, English or French. We also offer in-house training at our offices in Frankfurt, Germany.
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Pharmaceutical Experience
The founders of SHP have more than 10 years experience in working with the pharmaceutical industry.
SHP was founded in 2001 and develops the TVT especially for the pharmaceutical market. The TVT has consistently captured more and more of the market since its launch 3 years ago.
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Client base
A large client base, drawn from diverse companies and different markets (not only pharmaceuticals), has provided SHP with broad practical experience in all aspects of the printing process and viable solutions to typographical problems.
Customers range from small pharmaceutical companies with only 50 employees to truly global organisations with as many as 100,000 employees worldwide.
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Software Development Procedures
The SHP software development processes are GMP compliant.
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ISO Certified
SHP is the proud owner of an ISO 9001:2000 certificate, granted for the "Design and Development of Software for Regulated Environments".
The TVT is developed under GAMP4 conditions and SHP has been audited successfully by pharmaceutical companies for compliance with their quality standards and GAMP4.
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Validation Services
SHP offers extensive validation services for the TVT, incl. IQ, PQ, OQ, protocols and test cases.
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Price
The price of a single TVT license depends on the number of licenses a customer orders.
SHP offers a rebate for large orders.
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Spell check and medical dictionary
A comparison tool must maintain the integrity of the files. For quality reasons, spell checks should be conducted at an earlier stage in the workflow.
Spelling should be checked prior to using the TVT. The need for a spell check places the integrity of the original document in question, suggesting that it is not of the quality required for use as an approved file.
Similarly, any need to consult a dictionary at this stage casts doubt on the integrity of the approved document.
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September 2007
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