The structure of the document produced by Dossier Manager complies with the Colipa 2011 and SANCO 2013 guidelines.
After collecting the information managed during phase 1 of the method and those defined in the "INCI label / composition" phase, Dossier Manager organizes them according to the structure prepared and performs the calculations required for the evaluation, such as the calculation of the MoS and of the SED.
In this way the PIF is generated in a simple and fast way.
Product Information File.
In each chapter a comment is then posted on the Responsible Person or the Security Assessor. Password profiling guarantees the ownership of information and traceability of operations.
To assist the operator in this phase, the guide texts, prepared by the regulatory staff, are proposed by the software.
In ogni capitolo vengono riportati i documenti allegati a singoli componenti del PIF importati dall’area Dati di Base e Dati Tecnici.
The organization of attachments imported into the PIF is managed in a tabular way by Dossier Manager and can be customized by the user.
Furthermore, other external reference documents can be attached to each chapter.
The PIF is a Controlled Document. The responsible functions define the validation of all that is contained in the document. Furthermore, the PIF must be kept updated over time.
To support the Responsible Person and the Security Evaluator in the maintenance, the Check tool recognizes any changes that occur within the Document with a copy of the PIF having status: In Processing, where all the changes have been collected.
The document is brought to status: Validated for subsequent approval by the safety assessor. The status: Archived allows you to keep an archive of obsolete documents.
The identification of changes is simplified by the use of a semantic traffic light system. The analysis of changes is facilitated by a type of "before and after" visualization.