title: Process validation: removing the magic, mystery, and mayhem.
authors.forename: Arthur J
authors.initials: AJ
authors.lastname: Ward
mesh_terms: D001698:Biomedical Engineering / Q000379:methods* / Q000592:standards*; D001709:Biotechnology / Q000379:methods / Q000592:standards; D018795:Device Approval / Q000592:standards*; D004864:Equipment and Supplies / Q000592:standards*; D005062:European Union; D019983:Guideline Adherence / Q000458:organization & administration* / Q000592:standards*; D017064:Process Assessment, Health Care / Q000379:methods* / Q000458:organization & administration / Q000592:standards*; D011786:Quality Control; D014481:United States