EasyMatch QC-ER V&C Notebook

EasyMatch QC software is available with Electronic Record Keeping capability and meets the software requirements for 21 CFR Part 11 compliance. This version of the software protects and maintains complete and accurate records, limits system access, performs authority checks, provides a computer-generated audit trail and includes an electronic signature.

INCLUDED WITH EASYMATCH QC-ER SOFTWARE

 

The EasyMatch QC-ER Validation and Compliance Notebook include:

SECTION 1 – 21 CFR PART 11 COMPLIANCE

 

  • What is CFR 21 Part 11
  • How HL helps customers achieve compliance.
  • Predicate Rules
  • Setting up a Windows Operating System
  • Definitions

 

SECTION 2: IQ/OQ/PQ QUALIFICATION PROTOCOLS

 

  • System overview
  • Qualification protocols overview
  • Installation Qualification Protocols for hardware and software
  • Operational Qualification Protocols
  • Performance Qualification Protocols

 

HunterLab onsite instrument qualification is also available.