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FDA issued a very comprehensive guidance on systems validation.

This white paper uses that FDA guidance as an input to define an “easy-to-implement” framework for systems validation.

Hence, 21 CFR Part 11 also specifies a number of requirements for software systems to enable trustworthy and reliable electronic records and signatures - see Figure 1.

These software requirements must be met for the resulting electronic records to comply with FDA's c GMP.

After the root cause has been identified, Corrective Action (CAPA) items are created.

In order to comply with c GMP, companies are required to record, track, manage, store and easily access various production documents and their detailed change history including Standard Operating Procedures (SOPs), Master Production Batch Record (MPBR), Production Batch Record (PBR), Equipment log books etc.

The potential impact might include FDA requested recall, FDA mandated recall, Warning Letter, seizure, injunction, prosecution, civil penalties, and detention Figure 1: Scope of 21CFR Part 11 Requirements Source: CGE&Y (Please click on image for enhanced version) System Validation is a key 21CFR Part 11 requirement - its primary benefit is to assure quality and performance of the systems deployed to manage any c Gx P process.

It is the establishment of documented evidence that provides a high degree of assurance that a specific process, managed by the system, will consistently yield a product meeting its predetermined specifications and quality attributes.

The ultimate goal of any system validation project is to realize and sustain compliance, while ensuring the peak performance and functionality of those systems. Validation is the process of compiling written verification of all system functions and the performance of those functions to system specifications, as well as data integrity and system maintenance.

That written documentation must be in alignment with the industry standards and regulatory laws that guide the FDA in their evaluation and enforcement of regulatory compliance.

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