Case Study
Merck Pharmaceutical Site Accelerates Software Implementation and Validation
Merck Arklow (Sigma Aldrich Ireland Limited) is an affiliate of Merck KGaA, Darmstadt, Germany. The site is FDA and HPRA inspected and approved to work to ICH Q7, supplying commercial and late-stage APIs. The combined use of an Agilent Validation Starter Kit with Compliance Consultancy simplified the validation burden and reduced the implementation timeline by approximately 60% for a Chromatography Data System (CDS). “The real-time support provided by Agilent consultants involved in deployment and CSV was superb and effective in delivering upon the expectations of the Merck Arklow site” David Mythen 1 Quality Engineer Technology Lead Merck enhances laboratory automation and speeds up software validation using the Agilent Validation Starter Kit and Consultancy Services