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A Computer System Validation is a set of activities that FDA Regulated companies must conduct for each of their GxP sensitive computer systems. The objective of these activities is to document evidence that each computer system will fulfill its intended purpose in a GxP production, laboratory, or research operation.

GAMP® defines various categories of software that must all be validated. In general the major effort is spent on Categories 3, 4 and 5. The level of customisation and validation required generally increases with category but also depends on the risk assessment for the software in question. The diagrams below show the various categories and where ProcedureCapture can be used for validation purposes. Categories 1 and 2 are not shown as they typically include Operating Systems (GAMP® 4), Infrastructure Software (GAMP® 5) and Firmware GAMP® 4). The development / validation life cycle is shown in the diagrams below represented in the "V" model format as defined in GAMP®: GxP Good Testing Practices.

Category 3 is the simplest category that requires validation and is usually for "off the shelf" software that requires configuration via package options only.

Category 4 software usually allows customisation of the software package through vendor provided customisation screens. Category 4 software packages do not usually allow custom programming (these would be Category 5).

Category 5 software encompasses the whole software development lifecycle and typically includes packages that require custom programming. Bespoke software or "off the shelf" software that has a programming component would usually be Category 5.

ProcedureCapture enables you to automatically capture a 'visual storyboard' of any Business Procedure or Work Instruction that is performed on a computer.

While Computer System Validation involves more than just testing, ProcedureCapture produces test scripts and results along with end user SOP's and training materials.

  • Installation Qualification (IQ) Scripts and Results
    • Test cases for checking that System has been installed correctly in User environment
    • Results of execution and deviations from expected results (if any)

  • Operational Qualification (OQ) Scripts and Results
    • Test cases for checking that System does what it is intended to do in User environment
    • Results of executing and deviations from expected results (if any)

  • End user SOPs (Standard Operating Procedures) and Training Materials
    Documented procedures for users, system administrators, and IT related functions such as Backup & Restore and Archiving.
ProcedureCapture Validation

According to both Eudralex Volume 4 Annex 11 and the second edition of the GAMP "Testing of GxP Systems" good practice guide, there is no need to formally validate automated testing tools and you need only to qualify and assess them against your requirements.

GAMP® states in section 2.3 Verification of Computerized Test Management and Automated Test Tools that

"Because such tools have only an indirect impact on product quality they are considered to be low risk priority and do not require a detailed or lengthy validation process. The verification of a computerized test management or automated test tool should focus on demonstrating that the tools are fit for purpose as a as critical requirements are concerned" and that "Test data managed within the test tools would not usually be determined to be an electronic record within the scope of predicate rules".

While this may well be the case, ProcedureCapture still offers to regulated organizations an integrated regulatory compliance solution for successfully meeting compliance requirements while lowering the associated costs that can otherwise be substantial.

ProcedureCapture components that address the FDA 21 CFR requirements:

Please note however that Software products such as ProcedureCapture cannot be certified or validated themselves. Only the end product (project) of the customer can be validated. The software product, however, has to offer the functionalities to enable the customer to create a validated project.

ProcedureCapture has also been fully documented and tested by Raltus as part of our comprehensive quality system. Raltus performs extensive testing on all of its products using the same discipline to develop, execute and document test scripts, protocols and product testing as is required by FDA guidelines.

Validation Kit
If required, Raltus offers a Validation Kit containing key templates and protocols, that will reduce the effort required to develop your validation approach. In addition to Raltus's internal test documentation, the kit includes:

  • Validation Plan template
  • User Requirements Specification template
  • Design Specification template
  • Installation Qualification Protocol
  • Operational Qualification Protocol

Further Risk Evaluation points
A further consideration in assessing the risk of ProcedureCapture over traditional automation tools is that ProcedureCapture drives the automation from screen images only and does not use the underlying objects of the application under test. We only use documented and published operating system interfaces for our screen driven automation and don't rely on custom API's, code injection, or dependency on application versions.

Please e-mail us if you require any further info on this at

* GAMP is a registered trademark of ISPE

To see how ProcedureCapture works, please click here.
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