ELPRO’s solution for a straightforward cold chain monitoring is based on a new ISO standard for PDF files. ISO 19005-1 Document Management: Standardized file format for electronic documents for long term archiving.
 

Assured quality

  • PDF/A is an ISO approved standard
  • Alarm indicator conforms with WHO standards
  • Supports compliance with FDA standard 21 CFR part 11
  • ELPRO validation certificate and IQ/OQ documents

Service

  • ISO 9001 quality system
  • Vendor and internal audits
  • Expert systems
  • Own production and development
  • Own calibration laboratory
  • Calibration according to all standards
  • Customer calibration service
  • Modern facilities
  • Data Logger service since 1989
  • Repair service for all products
  • IQ/OQ qualifications
  • Temperature mapping service
  • Worldwide distributors
  • Return of ELPRO instruments and batteries for eco-friendly disposal

Directives & Standards

  • ISO 9001:2000: SGS certificate no. CH98/0013
  • CE: EN 500812 and EN 500822
  • EN12830/EN13485/EN13486: Temperature recorder for transport, storage and distribution of foodstuffs

Integrated regulations and recommendations

  • GMP/GLP/GAMP 4: Software validation in accordance with 21 CFR Part 820, Electronic Records 21 CFR Part 11, 21 CFR Part 210/211, 21 CFR Part 110, 21 CFR Part 58
  • EG/EU: Regulation (EC) 37/2005, Directive 2002/95/EC (RoHS)
  • HACCP: Hazard Analysis Critical Control Points