Computer System Validation

Data /Integrity App


 

According to both American FDA and UK MHRA, computer system validation is defined as “Confirmation by examination and provision of objective evidence that software specifications conform to user needs and intended uses, and that the particular requirements implemented through software can be consistently fulfilled”

Validation of computer systems is not a onetime event it periodic activity.

CSV should be performed by person other than those responsible for building system.


Purpose of CSV:

The purpose of the validation process is to provide a high degree of assurance that a specific process (or in this case computer system) will consistently produce a product (control information or data) which meets predetermined specifications and quality attributes.


Need of CSV:

FDA regulations mandate the need to perform Computer System Validation and these regulations have the impact of law.

 Having the evidence that computer systems are correct for their purpose and operating properly represents a good business practice.

 

All CSV activities should be documented with the following:

  • System inventory and assessment – determination of which systems need to be validated
  • User requirement specifications – clearly defines what the system should do, along with operational (regulatory) constraints
  • Functional requirement specifications – clearly defines how the system will look and function for the user to be able to achieve the user requirements.
  • Validation Plan (VP) – defines objectives of the validation and approach for maintaining validation status
  • Validation Risk assessments – analysis of failure scenarios to determine scope of validation efforts
  • Validation Traceability Matrix – cross reference between user and functional requirements and verification that everything has been tested
  • Network and Infrastructure Qualification – documentation showing that the network and infrastructure hardware/software supporting the application system being validated has been installed correctly and is functioning as intended
  • Installation Qualification (IQ) Scripts and Results – test cases for checking that system has been installed correctly in user environment
  • Operational Qualification (OQ) Scripts and Results – test cases for checking that system does what it is intended to do in user environment
  • Performance Qualification (PQ) Scripts and Results – test cases for checking that System does what it is intended to do with trained people following SOPs in the production environment even under worst case conditions
  • Validation Report – a review of all activities and documents against the Validation Plan
  • System Release Documentation – documents that validation activities are complete and the system is available for intended use.

“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.


Comments

Post a Comment

Popular posts from this blog

GxP Assessment & Categorization of Computerized System

Image
Data Integrity App The result of the GxP Assessment and system Category checklist decided whether Validation required for computerized system. If Outcome is “GxP Applicable” then follow Computer system validation procedure and other risk assessment for validating the system. All systems which handle data or processes which fall under the impact of GxP or any other regulatory requirements must be validated Determine whether the application has been validated elsewhere you in organization. The amount of work required may be significantly reduced by referring some of the deliverables in as in state or with slight changes. The details must be addressed in the change control. If required any “Non GxP Applicable “systems that process data critical to operations of the business such as those involving financial, certain personal data etc. Quality assurance, IT, CSV responsibility person, HOD of User department may consider the validation of such systems as a part of good business prac...
Read more

Data Integrity Thread

Image
Data Integrity App Data integrity can be compromised through human error or, worse yet, through malicious acts. Data that’s accidentally altered during the transfer from one device to another, for example, can be compromised, or even destroyed by hackers. Common threats that can alter the state of data integrity include: Human error Unintended transfer errors Misconfigurations and security errors Malware, insider threats, and cyber attacks Compromised hardware So how do you know when your data has integrity? You have to look at the following features: Retrieve ability and accessibility – It’s important to have accurate data in the proper locations at the right time when anyone is working on projections, a deal, or presentation. Without proper and easy access and retrieval, it can be detrimental to the business, yielding the way for your competition to win. Traceability – Today, you can trace every touchpoint you make with a prospect or cu...
Read more

Minimize Data Integrity issue

Image
Data Integrity App   What is data integrity? It is important to understand what data integrity really means in order to be compliant. Data integrity refers to the fact that data must be reliable and accurate over its entire lifecycle.   Data integrity and data security go hand in hand, even though they’re separate concepts. Uncorrupted data (integrity) is considered to be whole and then stay unchanged relative to that complete state.   Maintaining or keeping data consistent  throughout its lifecycle  is a matter of protecting it (security) so that it’s reliable. And data that’s reliable is simply able to meet certain standards, with which compliance is necessary.   For example, the FDA uses the acronym ALCOA to define data integrity standards and to relate to good manufacturing practices. Data is expected to be: 1.          Attributable – Data should clearly demonstrate who observed and recorded it, when ...
Read more