Sunday, November 9, 2008

Computerised System Validation - Part 1

Computerised System Validation is the Big Topic and will be posted in several posts, hence the part number mentioned in the topic
Computerised systems are increasingly being implemented to realise operational benefits
within manufacturing working environments. It is essential that there are controls in place
to ensure such systems are validated as fit for purpose
To provide guidance when implementing Computerised System Validation.
To provide specific additional guidance on the approach to validating different types of
computerised systems
This guideline applies to all sites and companies manufacturing, distributing or marketing
materials, products or devices for use or sale by, or for, XXX Pharma.
This guideline applies to computerised systems that are used in support of those agency
regulated manufacturing of pharmaceutical, biologic/biopharmaceutical, and healthcare
products requiring computer validation. Agency regulations include but are not limited to:
• Adverse Event Reporting.
• Electronic Records and Electronic Signatures (ERES).
• Good Distribution Practices (GDP).
• Good Laboratory Practices (GLP).
• Good Manufacturing Practices (GMP).
Everywhere in this guideline GDP, GLP and GMP and are collectively referred to as GxP
In the heading Users may find the part Number since the topic needs to be covered in several parts as one post may not be possible for the auther to prepare and Post. The Final Post in this topic, part Number will be mentioned as Final.
To view Computerised System Validation - Part 2 Click here
To view Computerised System Validation - Part 3 Click here

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