6 Most Important Elements for Business Continuity Plan for cGXP Computerised Systems

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Today we are with you to discuss the 6 Most Important Elements for Business Continuity Plan for cGXP Computerised Systems.

The requirements about business continuity plan are very clear, for the availability of computerized systems supporting critical processes, provisions

Should be made to ensure continuity of support for those processes in the event of a system breakdown (e.g. a manual or alternative system).

The time required to bring the alternative arrangements into use should be based on risk and appropriate for a particular system and the business process it supports.

These arrangements should be adequately documented and tested.

Hence today we will discuss, how practically we can prepare a robust business continuity plan for our cGXP Computerised system.

Before the start of our discussion, we would like to inform you that, many people refer disaster recovery plan as a business continuity plan.

Here we would like to inform you all that, the disaster recovery plan is a small part of the business continuity plan.

Where the data backup, storage, and restoration and further verification of restoration of data are considered.

The robust business continuity plan should address at least below mentioned six elements:

  1. Event Detection,

  2. Business Process Impact Evaluation,

  3. Repair Operations,

  4. Business Continuity Deployment,

  5. Recovery and Restoration operations,

  6. Return to Normal Operations and Business Continuity Process Closure.

Let us understand one by one element.

Event detection.

Under this element, the event should be detected and recorded as per site procedures, e.g. quality event management, incident or deviation management procedure, etc.

Under this head, we need to evaluate the event cause like,

The event may be related to loss of data for example due to connectivity failure or system unavailability

OR

The event may be related to the security of the data for example due to a possible cyber-attack,

OR

The event may be related to change in the local area environment for example increase in temperature

OR

The event may be related to natural disasters, for example, fire or earthquake, etc.

We have to consider each such event that can be resolved and evaluate maximumly tolerable unavailability of the system and the same should be recorded in our business continuity plan.

Business process impact evaluation.

Under this element, we have to study a business process impact evaluation considering the identification of functionalities or workflows potentially affected by the system unavailability as well as the business functions and their dependencies impacted (e.g. number of entities, users, the geographical area impacted).

We can make use of the Quality Risk management process for Business process impact evaluation.

Repair operations.

Under this element, in parallel with the deployment of the business continuity process, repair operations should be initiated in order to restore normal usage conditions of the system.

These operations should be managed in accordance with a change control procedure and should be associated with testing activities and data review, before approval and release of the repaired system for production usage.

we want to tell you that, while evaluation these requirements, We come to know that, many companies received FDA 483 observations and warning letters also.

You can refer to many such observations under the FDA database.

Business continuity deployment.

Under this element, we have to consider the activation of the predefined manual or automated operating process.

For example, either we can have manual operations with manual controls for record-keeping and data integrity or we can make use of alternate systems, you can make use of a disaster recovery plan for example in case of server breakdown we can move to an alternate server or you can make use of restoration of the backup data so as to ensure smooth business operations.

The next element we should consider is,

Recovery and restoration operations.

As per this element, we have to set a clear process for prioritizing system recovery before returning a GxP computerized system to normal activity.

The process may include,

  • Method of recovery,

  • The sequence of system functionalities or workflows to be restored in priority order

  • Reconciliation of activities performed outside the system

for example entry of data managed during interim manual or automated process discussed during the previous element.

The last and very important element for a

The business continuity plan is Return to normal operations and business continuity process closure.

As per this element, we have to authorize the termination of the business continuity process, by Verification of business continuity activities, performed and Communication to system users and stakeholders about the return to normal usage.

Hope you understood how to make a robust business continuity plan for cGXP Computerised systems.

Thank You.

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