GxP Assessment &amp; Categorization of Computerized System
By: Bahgwat Sonwane
Tags: FDA, Data Integrity, Pharmaceutical, Quality Assurance, Validation

In Earlier post we understand what steps which should be executed during computer system Validation activity. These steps will helpful to understand how CSV will be performed.

Now in this article we are going to understand GxP Assessment & Categorization of Computerized System. It is first stage of whether a system requires a validation is to identify whether the system has a GxP impact.

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 practice.

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GxP Assessment of Computerized System:

GxP Assessment determines whether a system requires a validation to identify whether the system has a GxP impact.

Perform GxP assessment using below Questioners:

Is the system used to generate data used in support of a regulatory submission? Is the system is used to monitor, control or supervise a GxP manufacturing or packaging process and have the potential to affect Product Quality, Safety, Identity or Efficacy? Is the system used to hold and/or manipulate clinical study data? Is the system used to monitor, control or supervise packaging and labeling operations? Is system used to create critical study control data? Does the system hold electronic records that are or could be used in electronic form to make GxP decisions? Is the system used to transmit e-data/ records to other systems for the execution of GxP activities? Is the system is used for GxP analytical quality control? The system manipulates data, or produces reports, to be used by GxP quality related decision authorization / approval processes, where the data supports the decision process or the electronic record constitutes the master record. Is the system is used to maintain compliance with a GxP requirement? Is the system is used to monitor, control or supervise warehouse or distribution within a GxP requirement? Is the system is used for GxP batch sentencing or batch records? Is the system used to store GxP documents for example SOPs, Specifications, BMR, BPR,DMF Is the system used for GxP data backup, restore, archival or storage, data security or access / domain control? Is the system used for physical access to GxP to the environment (i.e. area or location)? Does the system support a GxP application i.e. LAN/WAN?

If any of the above questions are answered “Yes” then the system has a GxP impact and the system requires a level of Validation and control through the Computer Systems Validation.

If all the questions are answered “No” then the system may be deemed not to have a GxP Impact. This should be documented to support the decision not to perform formal validation.

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System Categorization:

Refer below checklist shall be used to classify the systems into one of the System Categories

Is the system established commercially and is used to run other programs/applications? Does the system consist of software which is not directly useful for business purposes but makes the computer hardware useful? An example is the Windows Operating System? Is the system used to perform basic tasks, such as recognizing input from the keyboard, sending output to the display screen, keeping track of files and directories on the disk, and controlling peripheral devices such as disk drives and printers? Is the system available as a ready-made product for sale to the general public? Can the system be implemented without performing any customization or configuration to it (i.e. system will be used “As-Is”)? Can the system be configured for use for a specific function without altering the basic program? In other words, can the system be tailored to meet your business requirements/needs? Does the system consist of a program or group of programs specially designed for the end users?

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Based on above mentioned question Application software falls into one of the categories as -

Category 1: Operating System

[Note: If the answer to question 1 to 3 is Yes, then this category is applicable]

2. Category 3: Standard Software Packages (Commercial Off the Shelf (COTS) As-Is)

[Note: If the answer to question 4 and 5 is Yes, then this category is applicable]

3. Category 4: Configurable Software Packages (Configurable COTS)

[Note: If the answer to question 4 and 6 is Yes, then this category is applicable]

4. Category 5: Custom (Bespoke) Software

[Note: If the answer to question 7 is Yes, then this category is applicable.]

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