cropped-Logo_S4BT-_web_2019_White.png
PROJECTS

Issuance of certificates of analysis in electronic format

Client: a company that has always been involved in the research, development and marketing of innovative medicines.

Sector: Pharmaceuticals

Objective: to improve and optimise the flow of issuing Certificates of Analysis

Project

The purpose of the Project was to improve and optimise the flow of issuing Certificates of Analysis relating to finished products, raw materials, and primary packaging materials. The client company decided to introduce new software to manage the creation, revision, and approval of the Certificate itself.

Our contribution

The work of the S4BT Consultant was split into two macro-activities:

  1. Test the functionality of a new software designed to manage the creation and electronic signature of the Certificate of Analysis by the QC Manager or the Qualified Person;
  2. Create a new procedure to report all information relating to the issuance of the Certificate of Analysis in electronic format.

Result

  • Reduction of Certificate of Analysis creation times;
  • Reduction and optimisation of Certificate of Analysis review and approval times;
  • Reduction in response times to requests from regulatory bodies and Customer Account Coordinators;
  • Evidence of Certificate of Analysis revision, missing in the paper flow
  • Savings in resources and space as document archiving is managed directly in the system.
read about other projects
QUALITY & REGULATORY
CONSULTANCY SERVICES PURCHASED BY THE CLIENT COMPANY
REQUEST MORE INFORMATION
Privacy Policy

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

Download the in-depth study

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

Download the in-depth study
Read the article