Gruppo SASI s.r.l

is a company of software and services, modern and innovative, which since 2008 has successfully addressed pharmaceutical, chemical and medical device companies to face the various management problems that from time to time the market has placed in the priorities of management resolution.

Its professionals know how to move successfully in the management of organizational complexity with an high design competence accrued on the field sharing with its customers the implementation of core-business applications, and ensuring them a cost-ratiovery competitive performance.

In fact, it manifests itself to its customers with a balanced approach that finds its roots in the good tradition of the computer science profession and that incorporates those methodological sensitivities that over time the market has been able to propose to the attention of operators as true and actual opportunities to be catched.

He designed his own technological framework -

- for the management of information content that is the basis of its entire product line and that is addressed to all those operational processes that by nature require a careful management of their life cycle and as such must be certified.

Its architecture has been designed with the aim of giving the customer specialized applications that have a superior structural value, typical properties of a standard product, but also capable of expressing the characteristic value of custom-made applications of an end user.

Our main specialized applications have produced innovative solutions for the Pharmaceutical Industry relating to the design and the electronic submission of the Dossier of Registration of the Drug Product to the Regulatory Authority according to the organizational models defined by the CTD/eCTD standard.

Similar important solutions have been developed for the Chemicals sector in the design of the Drug Master File for the production of active ingredients for the Pharmaceutical Industry in compliance with the Applicant Part/Restricted Part standard and for the CEP to be submitted to the EDQM.

Another proposal of solutions for the Pharmaceutical Industry is offered by the application HosPurMan (Hospital Purchase Management) equipped with functions designed in their broadest definition both as regards the procedural and operational aspects governing the formulation of all types of tenders required by current legislation, and for cognitive processes, executive, management and administrative that proceed from them and that are the basis of the most sophisticated needs and expectations of the management structure of companies that offer their products to the Hospital Sector.

On the pharmacovigilance side we propose the solution called PSMF Manager, for the management of the Pharmacovigilance System Master File, which is developed in full compliance with the legislation in force for the European community published on the European Medicines Agency website (www.ema.europa.eu) whose legal requirement was introduced by Directive 2010/84/EU amending Directive 2001/83/EC.

Also for the Medical Device sector, our proposal TechFile Manager fully complies with all the regulations required by the European Parliament Regulations 2017/745-2017/746.

How to submit applications for marketing authorization, variations, renewals and ASMF (20/12/2018)

Notice to Pharmaceutical Companies

20/12/2018

We inform you that AIFA adheres to the eSubmission Roadmap adopted by the HMA and that, therefore, in accordance with Annex 2 of the HMA eSubmission Roadmap, starting from 1 January 2019, the obligation to use the electronic Common Technical Document (eCTD) extends to all regulatory activities concerning marketing authorizations issued with a national procedure.
For more information on the timing of the mandatory use of eCTD, Electronic Application Forms (eAF), please refer to the portal dedicated to eSubmission.

Attached the document:
link-image How to submit applications for AIC, variations, renewals and ASMF

eSubmission Roadmap (visual representation)

Annex 2

TechFile-Manager

TechFile-Manager, for Medical Devices, is developed in full compliance with the legislation in force for the European community as illustrated in REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009, and repealing Council Directives 90/385/EEC and 93/42/EEC.

The definition and structure of the Technical File is provided in Annex II "TECHNICAL DOCUMENTATION" and in the following subparagraphs, in Annex III "TECHNICAL DOCUMENTATION ON POST-MARKET SURVEILLANCE" and in Annex IV "EU DECLARATION OF CONFORMITY" and the organizational model useful to deal with the quantity of documents to be produced - and that will become mandatory from May 2021 - needs a computer tool comparable to a document management on the eCTD model in use in the pharmaceutical world.

TechFile-Manager is a tool equipped with the necessary features for validation including:

• User profiling: guarantees access and rights to both the various menu functions and documents;

• Versioning: every change made to every single paragraph of each edition is archived with the possibility of consultation and retrieval;

• Audit Trail: keeps track, with the possibility of consultation by authorized users, of the main operations carried out on the application.

In addition, the system meets the requirements of the Notified Body and is developed according to the guidelines in Gamp5.

TechFile-Manager supports the entire Technical File document cycle

By inserting the main metadata, which will subsequently be proposed and/or reused in subsequent editions (Name of Medical Devices, N°. Version, Holder, N°. Notified Body), the application will develop the entire document structure of which the Technical File is composed by inserting for all paragraphs the correct title, header and footer in the desired representative style; in addition, each document may possibly incorporate predefined templates (E.g. General Safety Requirements).

TechFile Manager generates the electronic Technical File without user involvement

Using the appropriate function from the main menu, the application automatically publishes, which creates the package to be sent to the Notified Body, consisting of the folder tree, the relevant paragraphs converted to pdf format with the relocation of hyperlinks, the indexing of chapters and subchapters and, above all, an Index.xml to use to navigate the Electronic Technical File.

TechFile Manager manages the Life Cycle

Starting from the second electronic edition of the Technical File, the application provides a sophisticated management of the "life cycle" that, in addition to automatically relocate all the hyperlinks present in the initial edition, through the identification of newly inserted or modified paragraphs, creates and/or increases, always without the intervention of the user, the n° of revision for the aforementioned paragraphs.

Techfile-Manager manages the tracking of consolidated editions

Always starting from the second edition of the Technical File, once generated the electronic structure, the application will store in a specific directory the files in pdf format highlighting the changes occurred in the paragraphs that are part of the Technical File.

To finish, we want to underline that the system is developed with the collaboration of specialists working in the field of Medical Devices and especially in the implementation and subsequent management of the Technical File.

Therefore, the result is a constantly careful design to meet the most complex application needs entrusting the system with the correct interpretation of the legislation to allow users to focus exclusively on professional content of their role facilitating and streamlining day-to-day activities impacting on the documentary management of the Technical File and making it easier the consultation for Notified Bodies.