Module, Regulatory
PIF Manager is the core module of Dossier Manager: from company data to the Label and the Product Information File, throughout the whole life of the cosmetic product.
The method, three phases
01
The data available in the company can be imported into the Dossier Manager tables.
02
Dossier Manager automatically composes the Label of the finished product and generates its Product Information File quickly and easily.
03
Dossier Manager takes into account technical-regulatory updates and internal changes by users for the entire life of the cosmetic product in question.
The module, features
The structure of the document produced by Dossier Manager complies with the Colipa 2011 and SANCO 2013 guidelines.
Management of toxicological data of raw materials.
Automatic calculation of the SED (System Exposure Dosage) and MoS (Margin of Safety) according to the SCCS guidelines.
Allergen management.
Automatic composition of the Label of the finished product, with automatic filtering of allergens and the possibility of automatically managing "may contain".
Generation and management of the Product Information File (including Product Information Documentation and Cosmetic Product Safety Report).
Web-based distribution of technical-regulatory updates.
Web distribution of COSING updates.
Controlled management of document status (version and revision).
Integrated management of external documents in .pdf (technical data sheets, safety data sheets, toxicological data sheets, literature).
Access management with levels of authorization and control (audit) structured by groups.
Check Dossier / Change Control function and monitoring of every variation, for the document assisted validation.
Detection of substances that are "critical" from a regulatory point of view (with restrictions, subject to Opinions, allergens).
Phase 1, technical data
From the item master data you can directly access all the technical data of the component or product in question.
Phase 2, label
After collecting the information managed in phase 1 of the method and that defined in the "label/INCI composition" phase, Dossier Manager organises it according to the predefined structure and performs the calculations required for the assessment, such as the calculation of the MoS and SED.
In this way the PIF is generated in a simple and fast way.
Automatic allergen filter according to Regulation 1223/2009.
Detection of substances that are "critical" from a regulatory point of view (with restrictions, subject to Opinions, allergens).
Check and updates: Dossier Manager takes into account technical-regulatory updates and internal changes by users for the whole life of the product.
Phase 2, document
A comment from the Responsible Person or the Safety Assessor is entered in each chapter. Password-based profiling guarantees ownership of the information and traceability of operations.
To assist the operator in this phase, the software offers testi guida predisposti dallo staff regulatory.
Each chapter shows the documents attached to the individual components of the PIF, imported from the Basic Data and Technical Data area.
The organisation of the attachments imported into the PIF is managed in table form by Dossier Manager and can be customised by the user.
Other external reference documents can be attached to each chapter.
Phase 3, control
The PIF is a Controlled Document. The responsible functions define the validation of everything contained in the document, which must also be kept up to date over time.
To support the Responsible Person and the Safety Assessor in keeping it up to date, the Check tool recognises every change made within the Document, with a copy of the PIF in the status In Progress where all the changes have been collected.
The document is brought to the status Validated for subsequent approval by the Safety Assessor. The status Archived makes it possible to keep an archive of obsolete documents.
Changes are easy to spot thanks to a semantic traffic-light system; analysis is made easier by a "before and after" view.
The software, modules
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