The intent of this chapter is to provide readers from different backgrounds (pharmaceutical scientists, quality assurance (QA) personnel, and qualification personnel) an improved understanding about which laws and regulations apply to the pharmaceutical industry and how they impact equipment qualification (...
Similar important solutions have been developed for the Chemicals sector in the design of the Drug Master File for the production of active ingredients for the Pharmaceutical Industry in compliance with the Applicant Part/Restricted Part standard and for the CEP to be submitted to the EDQM. Another...
Validation is based on the degree of risk involved with the product being produced: The greater the risk, the more of the FDA’s guidelines will apply to your validation process, and the more complex that process will be. For example, a company producing a pharmaceutical drug that will go...
Risk-Based Validation Brochure Read the latest informative pharma/biotech industry posts >>> How to Achieve Manufacturing Quality Compliance Success: Apply Automation REQUEST A DEMOAssurX: Quality & Compliance Systems for Every Enterprise AssurX is designed for every type of enterprise with strict qua...
Regardless of size, complexity, impact, and risk, the same expected activities and deliverables drive validation planning and approaches. COMPUTER SOFTWARE ASSURANCE (CSA) TO THE RESCUE After approximately six years of deliberation, collaborations between industry and FDA, and unanticipated delays (namely...
Validation of your project idea/ scope of your project Actionable insights on which technology would suit your requirements Industry specific best practices that can be applied to your project Implementation and engagement plan of action Ballpark estimate and time-frame for developmentFrequently asked ques...
In 2002, the FDA issued “General Principles of Software Validation; Final Guidance for Industry and FDA Staff,” requiring risk-based software validation. In 2008, the International Society for Pharmaceutical Engineering (ISPE) released “GAMP 5: A Risk-Based Approach to Compliant GxP Systems,” ...
In compliance with the data integrity requirements in pharmaceutical industry, medical device manufacturing and ISO 17025 accredited laboratories Read more Try DEMO EffiValidation 4.0 Focused on statistical data evaluation Method validation Uncertainty estimation ...
In compliance with the data integrity requirements in pharmaceutical industry, medical device manufacturing and ISO 17025 accredited laboratories Read more Try DEMO EffiValidation 4.0 Focused on statistical data evaluation Method validation Uncertainty estimation ...
Discover how the Definition of Done can be a good starting point for GxP validation in software development for the pharmaceutical industry. Paweł Przytuła August 26, 2024 Explore Possibilities Share Your Data Goals with Us From advanced analytics to platform development and pharma consulting, we...