Articles
  • Quality Process Automation is not only the requirement of well-established pharma companies but also there is a huge demand and need for automation in Pharma Startups Digital Transformation for growing companies is the need of the time as this will help the companies to battle the data integrity issues and standardize the quality process with Read More …

  • A long list of data integrity warnings received by pharma companies has made them train their focus on building and fortifying their tracking mechanisms to prevent things from going wrong. One of the solutions is digitization and building a data repository to make it easily available to analyze issues and predict challenges. However, the current Read More …

  • As digitalization has become inevitable, to fulfill their unique automaton requirements, businesses are either developing their software the traditional way or opt for ready-to-use software, which is touted to be cheap, but succumbs hefty monies for modification. On the other hand, besides consuming a dismal amount of money, the trample of traditional software development method Read More …

  • AmpleLogic: Offering GMP QMS to Achieve Optimum ROI The aging population, chronic and lifestyle diseases, emerging-market expansion, and treatment and technology advances are expected to spur life sciences sector growth in 2015. Furthermore, efforts by governments, health care providers, and health plans to reduce costs, improve outcomes, and demonstrate value is dramatically altering the health Read More …

  • What is GAMP 5? Good Automated Manufacturing Practice, Founded in 1991. International Society for Pharmaceutical Engineering (ISPE) sets the guidelines for manufacturers and the current Version is GAMP 5. GAMP describes a set of principles and procedures that help ensure that pharmaceutical Software (Like QMS software, LMS software, DMS software etc.) has required quality. Computer Read More …

  • Root Cause Analysis (RCA) is a method that is used to address a problem or non-conformance in the quality process to get to the “root cause” (actual cause of origin) of the non-conformity. RCA helps to correct or eliminate the cause and prevent the problem from recurring (preventive action). Root cause analyses is aimed at Read More …