Windows XP/Vista/7 and MS Word 2003/2007/20I0
CPU of 1 GHz, 256 MB RAM, SVGA graphic card, 400 MB 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.
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.
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.
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.
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.
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.
TVT is GxP and GAMP 5 compliant. A full audit trail ensures quality standards are met, such as CFR 21 Part 11.
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 GAMP4 conditions and SHP has been audited successfully by pharmaceutical companies for compliance with their quality standards and GAMP4.
TVT supports all of the world's major languages, including complex languages, (e.g. Thai, Hebrew and Arabic) and Braille.
TVT supports all standard file types including SPL, the FDA standard file: DOC, DOCX, RTF, TXT, HTML, PDF and SPL.
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.
For quality reasons, the TVT uses only genuine Adobe PDF libraries.
TVT is ISO certified (DIN EN ISO 9001:2008) for the "Design and Software Development for Regulated Environments".
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.