The Book Module
Fulfilling regulatory document requirements often tends to be time-consuming and an arduous task. ProductVision’s Book module makes it easy to create your Product Information File.
The Book module allows you to combine documents, images, attachments and other data from within ProductVision easily into a single “book” created as an Adobe PDF file.
You can easily define a “book” template using a simple interface specifying each section as a “chapter” where the required content is defined, either by selecting the required report, document, attachment or image. Flexibility comes from the ability to quickly write simple scripts to combine data from multiple sources from within the system. For example, you can easily include a safety data sheet document for each of the components on the formula. Once defined, the book template can be assigned to anything from a raw material to a project. A PIF, for example, would be assigned to a specific formula where the final book can be generated. The power of the Book module then combines all the necessary data, adding consecutive page numbers even to your external documents and automatically generating a professional-looking table of contents.
The Product Information File
For cosmetics products marketed in the EU, one needs to be aware of the European Cosmetics Regulation 1223/2009 Article 11. This article requires that a Product Information File (PIF) and a Risk Assessment be provided for each product placed on the market – both of which need to be updated for 10 years.
If you are tasked with the creation of a PIF, here is a sample of required documents:
- Product Information: the exact name and all the names in the national language where the product will be marketed, ID code and a description of the products function.
Part A – Cosmetic Product Safety Information:
- Quantitative and qualitive composition of the product – exact percentage
- Physical/chemical characteristics and stability of the product
- Microbiological quality
- Impurities, traces, information about the packaging
Part B – Cosmetic Product Safety Assessment:
- Statement on the safety of the cosmetic product
- Statement on the need to label any particular warnings and instructions of use
- Explanation of the scientific reasoning of the substances contained in the cosmetic product and on the Safety Information documentation
Cosmetic product labeling (container and packaging):
- Name and address of the responsible person
- The country of origin if the product is imported from countries outside of the EU
- Nominal content of the product, given by weight or volume
For more information about the Book module and how your company can utilize its benefits, click here or contact your ProductVision Support representative.
The ProductVision® product development software is a product lifecycle management (PLM) system that manages all aspects of the product development process. Suitable for industries including paint & coatings, personal care and food & beverage, ProductVision’s comprehensive list of modules includes Formula Management, Regulatory, GHS, Project Management, Document Management, Ingredient Labelling, Guidelines & Restrictions, Sample Tracking, Testing and Workflow. We have your complete development process covered no matter what your industry.