How confident can companies be that their regulatory and artwork documentation contains the correct text? During the last ten years, a tool has been developed that is now accepted as the industry standard in text verification.
Within the regulatory and artwork departments of many pharmaceutical companies one particular problem has tested the patience and ingenuity of document creators, approvers and managers. How can they safely and securely confirm that approved texts are transferred correctly between regulatory documents and artwork files?
When creating artwork using the contents of regulatory files, texts used are exported from the regulatory file into the artwork. While the same texts should appear in both documents, the artwork text will be in a different layout or format, making direct overlay comparison impossible. The traditional text-checking method was to print out the two documents and visually read them side by side. This is not only a time consuming and tiring task, but it also has inherent dangers that can cause, at best, embarrassment and, at worse, returns for rework, which may lead to costly recalls.
New standard
The Text Verification Tool (TVT) from Schlafender Hase is software that can compare documents within seconds, requiring the operator to simply review and comment on the differences found. TVT works by comparing the texts in two or more documents, ignoring everything that is the same and highlighting any differences found. It then presents these in a simple tabular format to allow the operator to work quickly through them.
Not only can TVT compare documents in Word, RTF, PDF and TXT formats, but it is configured to allow comparison of XML documents in the formats specified by the US FDA (Structured Product Labeling) and EMEA (Product Information Management). This gives users the certainty that when they are ready to implement these document formats they will have the tool that allows them to be checked against other formats.
Functional characteristics
TVT has the ability to check character and word differences, font style, size and attribute differences, as well as any change in the position of the text to ensure that no unwanted changes occur. The software gives the peace of mind that has not been possible with visual reading and releases personnel who would normally spend hours or even days checking over a pair of documents to undertake less onerous and more profitable tasks.
TVT works with all left- to-right and right-to-left reading languages as well as Japanese, Chinese and Korean-style pictogram languages. It can even compare multiple documents in a single inspection, for example, comparing a composite artwork file against the several different language files from which the text was drawn.
Industry approval
Clients of TVT include major international organisations such as sanofi-aventis, AstraZeneca, Gilead, Bristol Myers Squibb, Ratiopharm, Teva and Novo Nordisk. TVT clients are not averse to sharing their experiences of the software with recommendations.
"We have made it standard procedure to use the TVT at least once on every insert, word document and PDF that goes through our office," says Stefan Strychar, labeling technician, Teva Pharmaceuticals USA. "TVT is user-friendly and reduces the time we spend on manual proof-reading while maintaining the high quality of our texts," says Dorothea Köppe, senior European regulatory officer, Novo Nordisk.
"I’m very happy and pleased with the programme; it has made our life here a lot easier," says Camilla Skogman-Lindqvist, DRA associate, Novartis Finland.
TVT can help in many areas, not only in regulatory and artwork, but also for legal purposes. Anywhere that texts are transferred or modified, TVT can show what, if anything, has changed, thereby saving time and money. WPF