Why Validated Computerised Systems?
GLP and GCP regulations require that if a computerised system is involved in the process of generation, measurement, storage or assessment of data, then it must be validated to ensure the accuracy and integrity of the data generated by the system.
What is Computerised System Validation
Validation of computerised systems is a documented process to ensure that a system operates how the organisation requires it to.
This is done by generating evidence that the system functions(suitability for use) in a consistent and reproducible manner, ensuring data integrity and compliance with the applicable regulatory requirements. This documented evidence demonstrates that the system is suitable for use and the required purpose with the evidence to demonstrate confidence that the data generated is reliable and robust.
What is suitability for use?
The suitability for use of the computerised system involves confirming that it operates according to the organisation’s specific requirements. This is demonstrated during validation and routinely verified during use.
How is suitability for use demonstrated?
The suitability for use is demonstrated by confirming the computer system meets the organisation’s requirements. The organisation’s requirements are determined and documented as User Requirement Specifications (URS) prior to testing.
Key Requirements for Computer System Validation
1. Training
The regulations require anyone working within the organisation to demonstrate that they have sufficient knowledge and experience to fulfil the role and task they are undertaking. This requirement also applies to those conducting computer system validation.
2. Documented Procedures
The regulations require that Documented Procedures be established to ensure that computerised systems are suitable for their intended purpose and are operated and maintained in accordance with the regulations.
Cost of CSV in-house
The investment of time to establish a documented validation process and to validate a computerised system should not be underestimated by organisations.
Many organisations we support do not have in-house expertise, which lengthens the time to have a system validated.
From our experience, we have provided a breakdown of the time required to be invested by an organisation to develop procedures and validate an analytical instrument computerised system starting with a foundation of minimal CSV knowledge.
| Number of Hours | Comments | |
| Training | 24 | £1,600 per person – 3-day course |
| Documented Procedures / Templates | 160 | |
| Validation Plan | 12 | |
| Risk Assessment | 12 | |
| User Requirement Specification | 40 | |
| System Configuration Specification | 12 | |
| Test Scripts | 200 | |
| Test Conduct | 80 | |
| Traceability Matrix | 16 | |
| Data Integrity Assessment | 12 | |
| Validation Summary Report | 8 | |
| Quality Assurance Review | 40 | |
| Total Number of Hours | 616 | Equivalent to 77 days |
In the real world, it is not possible to have a dedicated person for CSV, and validation is a team effort for small or medium organisations. This is to be balanced with individuals’ day jobs; the time to completion can be lengthy; it has taken an organisation 2-years to validate a single analytical system. This means that from purchasing the instrumentation, the organisation has not been able to run regulatory samples on that system.
Computer System Validation Consulting
The Knowlogy CSV consulting services are flexible for your organisational needs.
Training
The Knowlogy can run CSV training internally for up to 12 delegates for your organisation. This runs over 3-days and covers all the principles of CSV applicable to your organisation at a cost of £5,330.
As an alternative, we provide hybrid training with a mixture of classroom training as an introduction to CSV with mentoring to personnel conducting CSV; this is “learning while doing”.
Documented Procedures
We can either review your current processes to provide assurance that they meet regulatory requirements, provide a CSV framework for your use or work with us to design and develop your processes.
Computer System Validation
The Knowlogy can provide consultancy for CSV at different levels and be flexible with options required by your organisation.
We have developed 3 tiers of CSV support with increasing levels of support and documentation so that you pay for only the services that fit your specific needs and budget. The more you invest, the more comprehensive service you receive.
We also recognise that you probably have more than one system to validate. We will design a plan which means employees gain knowledge so that, eventually, the organisation will be able to conduct CSV with minimal or no support.
| Basic | Premium | Complete | ||
| *Document Procedures | Framework only | YES | YES | |
| Validation Plan | Review | YES | ||
| Validation Risk Analysis | Review | YES | ||
| User Requirement Specification | Review | YES | ||
| System Configuration Specification | Review | YES | ||
| Validation test plan | Review | YES | ||
| Test Script | Review | YES | ||
| Testing | Review | YES | ||
| Traceability Matrix | Review | YES | ||
| Data Integrity Assessment | Review | YES | ||
| Validation Summary Report | Review | YES | ||
| Quality Assurance Audit | YES | |||
| Validation Support | YES | |||
| End-to-End project management and execution support (on-site and remote) | YES | |||
| Add-on services available with additional cost | ||||
| Documented Procedures | YES | |||
| Test Script | YES | YES | ||
| Expedited documentation | YES | YES | ||
| Quality Assurance Audit | YES | YES | ||
| Documented Procedure Review | YES | YES | ||
| CSV Mentoring | YES | YES | YES | |
*or alternatively documented procedure review if current procedures are available.
The Knowlogy Group supports life sciences research organisations. Our services include Software validation services.
The Knowlogy offers CSV expertise to support your organisation with the latest regulations. We have years of experience with numerous projects in research, GLP and GCP labs.
Strengthen Data Integrity and Regulatory Compliance with Knowlogy Group’s Expertise.
Contact us today to schedule a consultation and discover how we can help you achieve your CSV goals and enhance the quality and integrity of your research data.