Method validation and quality management software

We help ISO 17025:2005 accredited and GMP testing laboratories to ensure regulatory compliance and efficient operation by delivering quality management and method validation software that provides control and transparency through the laboratory processes.

Main advantages:

  • Compliance with the regulatory requirements, resulting in smooth audits and inspections, less stress for personnel, less observations and higher customer trust
  • Replacement of the old paper-, or MS Office-based system by a new, electronic quality management system, bringing more transparency and higher efficiency in internal processes, better reporting, prevention of quality issues and incidents, and continuous improvement
  • Data security, traceability and global availability

To evaluate the TRIAL version, please go to the Download page.

News

March 5, 2015

EffiValidation 4.0 launched.
To evaluate the TRIAL version, please go to the Download page.

October 12, 2014
New draft FDA Guidance for Industry: Analytical Procedures and Methods Validation for Drugs and Biologics

For more details and the draft guidance, please visit:

http://www.fda.gov/…cm386366.pdf

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Our Clients Include:

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