System design and controls


 

 Any computer system that is used in a Regulatory environment must have a secure user log on and password to prevent unauthorized use.

 

Full use should be made of access controls to ensure that people have access only to functionality that is appropriate for their job role and that actions are attributable to a specific individual.

Companies must be able to demonstrate the access levels granted to individual staff members and ensure that historical information regarding user access level is available. Controls should be applied at both the operating system and application levels.

The system administrator role, including any rights to alter files and settings, should be assigned to personnel independent from those responsible for the record content.

Shared logins or Generic user access should not be used. Where the computerized system design supports individual user access, this function must be used. This may require the purchase of additional licenses.

 

Shared, read-only user accounts that do not allow the user to modify data or settings are acceptable for viewing data.

 

Consider below point while implementing System design and controls

 

 Validation and life cycle package focusing on data flow, system configuration, data access, authorization and testing 

 Periodic controls to ensure data integrity

 Access rights

 Audit trails

 Is data saved contemporaneously? 

 How is the data reviewed? 

 Is an audit trail or activity log implemented? 

 Do the contents of the audit trail follow ALCOA principles? 

 Is the audit trail reviewed prior to disposition? 

 Are electronic records restricted from modification after e signature? 

 Can audit trails be enabled/disabled or deleted by the routine user? 

 Are date and time settings protected? 

 Do roles and privileges align with segregation of duties? Is original data obscured when modifications are made? 

 Does the system make testing into compliance detectable? 

 Have these parameters been tested? 

 


“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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