Handling inspections (well) through an electronic dossier

Handling inspections (well) through an electronic dossier

Life Science companies are subject to frequent inspections by partnersagencies and authorities. For example, you may receive an inspection when you introduce new lines, produce for new markets or simply have routine and/or follow-up inspections to check that the company is in line with regulations and guidelines.

A crucial stage during an inspection is the examination and review of documentation by the auditors, both in the preparation phase and during and after the inspection.

The documentation needed can be of any kind:

  • Personnel qualifications and training
  • Standard Operating Procedures (SOPs)
  • Qualification reports
  • Validation reports
  • Complaints
  • Change Control
  • Deviations
  • Etc.

Documentation Review – Remote Audits and Inspections

Documentation review has become an even more important activity for remote Audits, which, due to safety and travel constraints, have been replacing in-person audits over the last year, thanks to the great technological flexibility we have.

In remote Audits, the company being inspected (auditee) sends the required documentation to the inspectors (auditors) via a shared and previously agreed platform.

Now, imagine this documentation stage using paper systems, from the initial search for the document, to scanning it, saving the file in the folder and then sending. Quite a cumbersome process, if we consider, too, that it must be repeated for many documents.

Having those documents in digital form, on spreadsheets or in text files and saved in network folders, would certainly reduce the time involved. We also know that even in the most precise organisation, paper files in folders are prone to errorslosses and deterioration


Electronic dossier

Digitalising  work processes on a software platform that complies with regulatory standards and offers the ability to manage assets, digital signatures, attachments and documents is crucial during an inspection. 

Here is a practical example. An inspector wants to see documentation on deviations and related CAPAs for a particular batch. For paper documentation, as mentioned above, we would need to search in the archive folders, then scan them and share on the platform. For network files and folders, if we are organised, then we can “manage” with searching for all batch-related files and sharing them.

With a digital platform, by entering the batch number and using a simple search, we can trace one or more of the deviations the batch has encountered, the documents signed electronically, the tasks performed and also the relevant CAPAs. Once we have entered the single deviations process, we can extract a dossier, i.e. a protected pdf document summarising all information on the deviation and related processes and tasks, updated in real time and including attachments. 

The dossier can be opened, viewedsaved and printed, if necessary. During an inspection, especially remotely, it is extremely easy to go back to the documentation and share the dossier as a generated pdf file.

Customised Electronic Dossiers

The Standard Electronic Dossiers contain all the information on the process (tasks, owners, attachments and documents, etc.). 

However, not all companies can, or will, share such information with third parties, if not necessarily required to do so.

With PRAGMA4U , companies can create customised dossiers, entering the relevant process information that they want to pass on to the other party. This makes it possible to use the document for sending information to third parties, such as inspectors, but also, for example, as documentation for a customer in the event of a complaint.


PRAGMA4U is a modular and scalable Workflow Management System platform that digitises work processes in compliance with FDA and cGxP guidelines.

It enables companies to: have documentation that is protected, always up-to-date, organised and linked to the source processes; assign and implement workactivities directly on the platform; easily share information between departments; keep processes under control using KPIs; and compile reports  and dossiers  that will be useful for inspections.

The platform can contain multiple processes, creating a true digital map of the company. It also integrates with other systems, such as ERP, simplifying the compilation and updating of data.


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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


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