How to Conduct a GAP Assessment in Computer System Validation process.

 

In Earlier post we understood What is Validation Summary Report in Computer System Validation


Now in this article we are going to understand How to Conduct a GAP Assessment in Computer System Validation process.

 

What is GAP Assessments

GAP is nothing but difference between actual state and desired state.

A way to compare current conditions & practices in order to identify gaps and areas in need of improvement with regards to compliance to the relevant standards.

It  is the procedure to manage an organization to not only correct or improve their processes, but also identify processes which are in necessity of upgrade.

Gap Assessment is one of the best procedures to help lead an organization to not only improve their processes, but recognize which processes are in need of improvement.

The aim of GAP Assessment in Computer System Validation is to identify the gap between company’s existing procedures, practices and policies with respect to relevant regulatory guidelines and compliance standards.

The GAP Assessment involves evidence and it lays down the variance between requirements and existing strength.

A GAP Assessment is usually conducted before the validation activity starts. Effective GAP analysis helps maintaining and developing better compliance. 

 

Data Integrity App


Gap Assessment may have different purposes:
 To determine if a system to be purchased will comply with Part 11 before purchasing it
 To efficiently incorporate Part 11 compliance into your validation effort
 To assess existing systems for Part 11 compliance
 To remediate existing systems for Part 11 compliance




Steps involve in GAP Assessment:

• Identify the requirements for computer system/software

• Make a list of requirements this is usually in the form of questions.

• Identify the risk of computer system/software against the requirements

• The Gap Assessment questions are turned into action statements

• These action statements formulate remedial actions which will fill in the gaps Develop plans to address the gaps.

• Ensure that required documents & SOPs/Manuals are available

• Ensure that the specifications of computer system/software are according to requirements

• Mitigate the risk of computer system/software against the requirements

• To verify that computer system/software meets compliance standards

• Review of all current practices,

 

GAP Assessment benefits organizations in getting comprehensive approach to organization or respective function, this results in decreased project cost.


Strategy for Bridging the GAP

1.Clearly define accountabilities and responsibilities.

2.Monitor practices and tools for computerized system.

3.Revision control for reanalysed data.

4.Enforce operational checks to verify user permissions.

5.Enforce sequence of permitted steps according to a defined workflow.

6.Use predefined workflows.

7.Define “built-in” checkpoints within the systems.

8.Awareness – all levels are fundamental parts of the quality system.

9.Qualify analytical instruments before using them.

10.Guidance for Industry 21 CFR Part 11, Electronic Records and Electronic Signatures.

11 Document periodic review results, any gaps identified and remedial action thereafter.

12 Annual assessment of laboratory process control.

“Trust but Verify “ Ronald Reagan

 

Across the internet, there are millions of resources are available which provide information about Everything.

 

If you found all content under one roof then it will save your time, effort & you will more concentrated on your important activity.

Data Integrity App


 

Our Data integrity app will helpful for understanding what Data integrity & CSV really means & How 21 CFR Part 11, EU Annex 11 & other regulatory guidelines affects in pharmaceutical Industry.

 

Data Integrity App Include 

- Basic Data Integrity Concepts

- ERES & Its Requirement

- CSV & Its best practices 

- Mock Inspection and General Q&A

- Checklist for inspection

- Inspection Readiness

- Useful SOP’s

- Stay Regulatory Compliant.

 

“Stay One Step Ahead in Pharma IT Compliance” 


Data Integrity App Link:


https://play.google.com/store/apps/details?id=com.innovativeapps.dataintegrity

 

Try our "Data Integrity" app which helps you to better understand current regulatory agencies thinking on Data Integrity & CSV.


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