Workshop Data Integrity Advanced


PAST EVENT

Would you like to organise training on Data Integrity and Computer System Validation at your company? Fill out the form to request more information.

The workshop provides an in-depth analysis on Data Integrity, which sees data at the centre of all business processes.

Who is it intended for?

The Data Integrity Advanced workshop is aimed at professionals in the medical, chemical, pharmaceutical and cosmetic sectors who need to measure the level of adherence and culture of the Organisation towards Data Integrity.

Contents at a glance

The Workshop will illustrate highly effective methods for the analysis, control and prevention of the manipulation of data. The theory will be accompanied by practical examples, such as risk analysis applications, Data Mapping, maintenance techniques, and periodic controls.

It will also demonstrate the most modern IT systems to raise the overall level of security and integrity for your company data.

Key learnings

At the end of the Workshop, participants will have acquired practical tools to measure the level of compliance with Data Integrity through

  • Data Flow Mapping;
  • Data Integrity Assessment;
  • Risk Analysis towards ALCOA principles.
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COMPLAINTS

An aid to inspection work

Simplify the management of Complaints, from filing, through investigation, follow-up, judgment and final report.

The module is designed to provide step by step Quality Assurance support
in the implementation and supervision of the process and the assignment of tasks to the departments involved. The module supplements the CAPA procedure, which the user can open directly from the Complaints procedure.

PRAGMA-WFM documents and traces all activities and information in the Complaints process. In each phase, you can also attach files in various formats to support activities and investigations.

During inspection phases, the functionality dossier enables the real-time generation of a document that provides information and lists the activities of the process and related processes

AUDIT

Documents and traces activities

It simplifies the management of internal and external audits, from planning, through execution, to the management of remarks.

The module supplements procedures for handling CAPAs , Non Conformitiesand Change Control that the user can open directly from the audit to resolve the observations found.

PRAGMA-WFM documents and traces all activities and information of the Audit process. For each process step, it is possible to assign tasks to the people involved, and attach files in various formats.

Duringthe inspection phase, the dossierfunctioncan generate a document in real time which records the information and activities of the Audits and related processes