Managing Requirements Throughout Multiple Life Cycle Stages
Documenting and managing clear concise and testable requirements is the cornerstone for any successful...
Engineering with an S88 Approach (Part 3)
S88 and the Functional Specification both play vital roles in conceptual and preliminary design...
S88 – A New Approach to Engineering (Part 1)
The case study presented within this article revolves around creating concepts of process control...
Top Tips for Pharmaceutical Automation and Validation
Automation is generally considered as a risky subject because of the specialized and technical...
Eudralex Volume 4, Annex 11 – A Refresher!
Computerized Systems Installation of computerized systems is now an essential part of any manufacturing...
Engineering with an S88 Approach (Part 2)
Automation Engineering Since the I&PD has so many inadequacies, automation isn’t documented enough after...
S88 – A New Approach to Engineering (Part 1)
The case study presented within this article revolves around creating concepts of process control...
ASTM E2537 – Standard Guide for Application of Continuous Quality Verification
This efficient standard provides a science-based approach to ensuring that continuous processes’ are continuously...
Types of Validation Plans
The following documents are the most common types of validation plan documents: 1. SVMP...
Risk Based Approach to Validation
When we talk about validation and the requirement to validate even the simplest of...