Periodic System Review /Evaluation

 

Data Integrity App


Periodic System Review is to ensure that the computer system remains compliant with regulation, is fit for its intended use and satisfies company policies and procedures.

Conducting periodic reviews on GxP systems, assets and/or processes that have already been validated is a critical aspect in any validated environment.

 

It is important to review a system or process for changes – both physical and procedural – in order to verify that a system or process is operating as expected.


For the most part, management of periodic reviews is achieved using spreadsheets and other paper-driven tools.


This in turn equates to reliance upon a single user or group of users to ensure that periodic reviews are completed on time and documented accordingly. Through this reliance on human interaction the possibility of errors heightens and risk increases.

In this way human errors are removed from the process ensuring that users are aware in real time of the status of any periodic review.

 

Both the FDA and EU GMP’s detail the requirement for demonstrating that a computer system remains in a validated state throughout its operating history.


FDA 21 CFR 211.68(b) States:
 “Input to and output from the computer or related system of formulas or other records or data shall be checked for accuracy. The degree and frequency of input/output verification shall be based on the complexity and reliability of the computer or related system.”

EU Annex 15 States:
 “Facilities, systems, equipment and processes, including cleaning, should be periodically evaluated to confirm that they remain valid. Where no significant changes have been made to the validated status, a review with evidence that facilities, systems, equipment and processes meet the prescribed requirements fulfils the need for revalidation.”

 

 Frequency of Periodic Review

The frequency of Periodic Reviews based on the Complexity, Criticality, Novelty, and Operating History of the computer system.

For example an automated control system (Category 4 / 5) the computer system periodic review should be performed more frequently than an off the shelf item. The frequency of review should be defined with a minimum and maximum time between reviews. For example a scale of 1 to 4 years can be set for the review period.

Only new GAMP category 4 and 5 Computer Systems would have an annual review period.

Category 4/5 is configurable software so periodic review should be annually performed. For non-configurable systems starting with a frequency of 2 years when first installed through to a maximum 4 years once a stable operating history is established.


Method of periodic review:

The first is the traditional periodic review of the computer system which is performed at a predefined period.

The second is continual monitoring and trending with a review report.

 

Periodic system review considers: 

Physical & Logical security

Relevant Documentation (Incident, Deviation, change control, SOP’s)

Backup, Restore& Disaster recovery

Validation Status

Inventory (system ID, location & application software )

Audit trail

 

Periodic Review performed by

 Process Owner – Laboratory person who is responsible for the system

 System Owner –Person responsible for the availability and support of the system

 IT – System/IT Administrator

 Quality Assurance


Benefits of Computer System Periodic Review

Quality and the Business

Improve the operation

Maintain compliance

Support the continuous improvement

 

What other points are consider in the Periodic Review?

·         Roles and Responsibilities

·         Service Agreements

·         Validation/Qualification and Project Deliverables:

·         System Control Procedures

·         Audit Trail management

·         Incidents, Problems

·         Changes, Upgrades

·         Security, User Access, User Administration

·         User Guides

·         Backup, BCP, Performance, Reliability Monitoring

·         System Access Training

·         Archived Data




“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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