Pharmaceutical machine operating

The main objective of production managers in pharmaceutical production units is to get control over the quality of the manufactured products. One solution would be collecting data throughout the whole manufacturing process in order to check and handle potential variances. Informatization of the whole production and quality control operations track data allows to simplify this procedure.

The purpose of a traceability system may vary depending on the company’s functions and the users (from production to maintenance or quality aussurance).

The electronic batch record then becomes the shop window for the company’s know-how as it provides capital gains to the production tool while ensuring the recognition of the product’s quality. When being inspected or during audits, possessing an electronic batch record allows the company to demonstrate how much it cares about folllowing the rules and being totally transparent. In a state of crisis, electronic batch record offers the possibility of having swift access to a batch’s genealogy and to take precise and concrete actions (batch recalls etc).

 

On a day-to-day basis, Electronic Batch Record System allows to :

  • reduce the non quality, especially concerning the decrease in the number of mistakes made in the paper files information
  • ease the process flow by reducing the amount of time needed for compiling a file (simplification of file review)
  • improve the quality and safety of conditioning operations
  • refocus operators’ activity on value added actions (production or conditioning)
  • ease information and documents flow
  • ease file review concerning conditioning and batch release
  • reduce conditioning and batch release cycle time
  • increase quality control concerning batch release management

 

Our strenghts :

  • An excellent knowledge of pharmaceutical business and regulatory requirements (this specific sector concerns 40% of our turnover)
  • An extensive expertise concerning performance monitoring and maintenance informatization
  • A specific knowledge of current software solutions
  • An extensive expertise in computerized systems validation