PlantSTATS PHARMA - Quality monitoring

PlantSTATS PHARMA

Pharmaceutical Quality Monitoring - 21 CFR Part 11 Compliant

The accurate recording and timely analysis of In-process checks is a central element of any pharmaceutical manufacturing process.

PlantSTATS PHARMA complies with all EU and US standards to provide a complete solution to the real-time monitoring and reporting, and paperless storage of in-process check results.

 

Features

  • 21 CFR Part 11 Compliant
  • Customisable test plans lead operators through test procedure
  • Records variable data such as hardness, thickness, seal length and attributes such as barcodes, data codes, label and leaflet codes
  • Facility to monitor by filling head
  • Immediate alarms through screen, email or pager to alert operators and managers are available
  • OQ/IQ validation and detailed functional specification with corresponding test documentation
  • Central collection of data on database server
  • Ability to filter by product, date, status or production area
  • Professional reports and summaries
  • Support contract and regular software enhancements
  • Can be used on existing computers, with existing instruments* reducing costs and simplifying support

Optional modules available for:

  • Cephalosporin’s
  • Ampoules / vials

To discover more on how ICCS can manage all stages from user requirement specification through to installation call us on 01608-637121 or click here to email us. ICCS can project manage the complete job, assisting in everything from structured training, commissioning and assistance with validation, all in accordance with GAMP standards.

Data Sheet

PlantSTATS Data Sheet PlantSTATS PHARMA.pdf

Subject to minimum equipment specification*

“PlantSTATS PHARMA is the central element of the pharmaceutical manufacturing process at Recipharm Ashton Ltd, providing accurate and timely monitoring of product attributes.”

Kevin Tilley, Pharmaceutical Technologist at Recipharm Ashton Ltd

Read the full case study here