Vendor Evaluation Procedure for cGXP Computerized Systems

Overview:

The vendor evaluation is the key step followed during computerised system validation. Many companies are not focussing on this approach.

But as per EU Guide, The competence and reliability of a supplier are key factors when selecting a product or service provider. The need for an audit should be based on a risk assessment.

Quality system and audit information relating to suppliers or developers of software and implemented systems should be made available to inspectors on request.

Further FDA also expects the same. Additionally, Where ‘cloud’ or ‘virtual’ services are used, attention is expected to understand the service provided, ownership, retrieval, retention and security of data.    

Due to these requirements, this training program is organized to make you understand and implement the requirements to achieve compliance.

Why you should Attend:

The learning objectives are firstly understand the vendor evaluation process for cGXP computerised systems.  

How the vendors to be evaluated, why to evaluate and what aspects need to focus during the vendor evaluation process. 

The benefits are - 

• The person’s understanding about vendor evaluation process
• The person working in pharmaceutical will need to follow the requirements by different guidelines including GAMP 5 guide
• The person will get practical insight/approach about the topic so that they can implement it in their organization and protect organization from potential non-conformity observation/s

Areas Covered in the Session:

The major points covered include;

• Importance of topic
• Guideline Requirements - EU, FDA, GAMP
• Vendor Evaluation Process
• Risk based Decision Making
• Postal Assessment - Points to consider, when postal assessment is suitable, key points to consider during postal assessment.
• Onsite Audit Assessment - Supplier Good Practices Risk Management within the Validation Lifecycle

Who Will Benefit:

• Quality Assurance
• Quality Control
• Pharmaceutical IT Compliance
• Qlobal QA
• Corporate QA and QC
• IT personnel working or related to pharma IT support