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:

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;
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

CONSULTANCY SERVICES PURCHASED BY THE CLIENT COMPANY

Quality Control

REQUEST MORE INFORMATION

Project

Lorem ipsum dolor sit amet, consectetur adipiscing elit. Ut elit

Digitised processes

0 k

Projects completed in 2019

CLIENT

Pharmaceutical Company

An international pharmaceutical organisation specialising in the clinical and commercial development and production of pharmaceutical products with a high degree of toxicity.

Home office

Digital Company