Welcome to R2 Controls

 

Pharmaceutical

 


 


R2 Controls has lots of pharmaceutical validation experience working with KMI http://www.kminc.com.  Projects have included preparation of IQ's, OQ's, writing general validation requirements (for control systems), Y2K testing for control systems, developing control system standards, preparation of requirements documents, GAP analysis, vendor audits, and consulting.

Clients Include: Genetics Institute, Bayer, Lonza Biologics, Warner Lambert, Parke Davis and others

  • Installation Qualifications (Documentation and execution)
  • Operational Qualifications (Documentation and execution)
  • Validation tools & utilities
  • Performance Qualifications
  • Gap Analysis
  • BMS, PLC, SCADA, DCS, Control System compliance
  • Information Systems/Information Technology compliance
  • Communication Systems
  • Vendor Audits
  • Compliance investigations
  • GMP, GAMP
  • 21 C.F.R. part 11 system qualifications (for DCS)

 

 

Some useful links:

http://www.ispe.com

http://www.fda.gov

http://www.pda.org/catalog.html

 

 

 

Send mail to rys@R2Controls.com with questions or comments about this web site.
Last modified: 5 Jan 2017