HLS Service & Validation Ltd
 
This Cork based Company specialises in the provision Validation, Regulatory, Compliance and Service/Calibration Services. HLS  provides project-based consulting/contractual services to biotech and pharmaceutical companies that require such IMB/FDA regulated services. HLS can supplement a client's current validation staff for assistance on a specified project or we can provide a complete group of validation professionals to manage any Validation, Regulatory or Compliance project.

HLS offers the following Validation/ Regulatory/ Compliance services:

Sterilization, Clean/Pure Steam & SIP
  • Project management for the purchase and/or upgrade of new equipment and protocol development (through URS to PQ) and execution  
  • HTM 2010/EN 285 sterilizer and system audits/compliance execution
  • Retro fitting and validation of air detectors to all makes and types of sterilizers
  • Supply of steam quality test equipment, steam quality testing and specialist steam system audits
  • Temperature Distribution and/ or Penetration Studies utilizing Kaye Instruments metrology equipment and/or Biological Indicators (BI's)
  • Specialist third party maintenance service for all makes and types of sterilizers, SIP systems and clean steam generators

 Other Services
  • Validation Master Plan development 
  • SOP development
  • R/D document development
  • Process Validation
  • Protocol development (through URS to PQ) and execution 
  • Computer systems validation, including manual, automated or semiautomated processes (DCS, PLC or similarly-controlled system)
  • Final report compilation
  • Technical Writing services
  • Support for presentations to regulatory agencies including the IMB & FDA
  • Current Good Manufacturing Practices (cGMP) audits

Contact Information 
Andrew Varley - Director
HLS Service & Validation Ltd
Apt.E 5 Tivoli Villas
Wood View
Tivoli
Co.Cork
 
Tel + 353 (0) 21 4550864
Fax + 353 (0)21 4550864

Contact HLS Service & Validation Ltd

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