Visit our Laboratory Excellence dedicated page, our team can support your business through the entire implementation cycle.
Connect with us
Definitions
CDS: A Chromatographic Data System (CDS) is a computerized system that facilitates the definition, management and execution of chromatographic-based analysis. It allows the management of the analytical instrument (i.e. changing the temperature of a column, the detector wavelength or the gradient between several solutions), the acquisition of data, its adequate storing and processing including reports generation.
CSV: Computerized System Validation (CSV) is defined in the following way by FDA: “Computer system validation is the process of providing a high degree of assurance through documented evidence that a computer system consistently meet(s) its pre-determined or intended use or quality attributes such as accuracy, security, reliability and functionality.”
Why Validate a CDS?
The regulatory inspections of these systems demonstrated the level of documentation provided by a vendor, which usually includes a significant amount of vendor-recommended requirements, testing scenarios and documented evidence of executed verifications including vendor quality unit final approval of executed activity. This vendor package is typically presented in several hundreds - even thousands - of pages; so, the frequently asked question is: Why do I need to perform a Validation activity if a vendor built/executed this significant amount of verifications?
The main reason for executing a Validation exercise is that the vendor is not necessarily aware of your specific intended uses of the system, including which role you plan to select for the execution of some activity, which configurations you are going to apply and which instruments you will use via the identified CDS.
For this reason, it is required to perform a set of customer-specific verifications (often termed Site Acceptance Testing = SAT), in addition to the vendor documentation (often termed Factory Acceptance Testing = FAT).
Clearly, a Validation exercise is required. The following provides more detail regarding the Validation activity.
Can the same vendor verifications be re-executed?
As stated earlier, the scope and goal of Factory Acceptance Testing and the System Validation are different. System Validation is focused on the intended use; this means that it is not required to verify each software functionality but the portions of the software, the functionalities and components that are required for the execution of the identified processes and analytical operations. For this reason, the Computerized System Validation should not be a simple repetition of existing verifications but should be focused on specific needs and formally identified as a set of requirements.
How to Validate a CDS
-
Requirements
The first step of an efficient Validation process is to develop the processes and requirements definition. Requirements should cover each area of the software utilization and it is important that, within this preliminary phase, these needs are identified in order to be able to incorporate them in the characteristics of the required software. This is going to be a key element of support for vendor selection. The implementation of a new CDS solution is one of the most significant prerequisites for the review of the processes in the laboratory area, with the possibility of simplification, alignment to best practices or process harmonization.
An important element that is extremely important for the successful progression of the overall deployment activity is to identify the full list of analytical devices that are to be managed via the CDS solution. Even if a significant amount of them are considered to be highly compatible with the identified solution, there is always old equipment or a “special” device that requires ad-hoc activities including patching, installation of specific drivers, etc. This additional effort should be incorporated as soon as possible in order to properly evaluate all the economical, temporal and validation related implications.
Other key questions may be:- Do I need to migrate data from the existing CDS solutions?
- Do I need to interface the CDS solution with other systems or other devices (balances, ELM, LIMS, etc.)?
- What are the applicable regulatory requirements?
-
System Design & Specifications
Based upon clear requirements, it is possible to define how the system should be designed, including but not limited to, infrastructure capabilities, policies, roles and, widely speaking, all configurations to be applied.
All these key elements are to be identified, formally documented and approved before proceeding with the formal verifications. -
Testing
It is of vital importance that the software is adequately tested. The testing phase is not limited only to meet regulatory expectations, but also to verify every individual functionality of interest and a combination of them in order to ensure that the defined requirements are met for the full execution of activities in the laboratory area. The level of testing should be defined though a risk-based approach.
It is strongly recommended that, in order to facilitate the execution of the identified verifications, a subset of the overall computerized system is identified, including one or a few instruments for a single network device for instrumentation control plus the required server components, and that a significant amount of the identified verifications within this reduced solution is performed. In this way, the first testing phase will be limited to just a few instruments without a significant loss of laboratory efficiency. After the successful completion of this first phase, it will be possible to connect all remaining laboratory instruments, in several steps or waves depending on the number, and perform remaining verifications minimizing as much impact as possible to business activities.
The testing phase is the last opportunity to identify issues, enhancements or other changes, therefore it is critical to perform this phase with the utmost attention. Usually improvements can be implemented following the system “go live”, but solving bugs or making changes while the system is in use and prior to when it is launched is highly recommended. It is far more complex to accomplish this once the system enters the testing phase.
A strong emphasis should be placed on a specific word of the Computerized System Validation definition by FDA: Documented. Please note that each step of the validation process is to be documented and everything that is not documented is not demonstrated, not accessible to inspections or audits, so in other words, if it is not documented, in the eyes of the regulatory agency it does not exist. -
Preparation to Go Live with CDS
The implementation of a CDS software system may represent a significant change in laboratory activities, and requires adequate planning. It is strongly recommended to plan in advance the right training activities and identify potential Go Live day criticalities, including, but not limited to, the presence of master data into the system and the availability of the appropriate hardware (printers, etc.).
The presence of adequate procedures for utilization and administration of the solution must be considered, including the presence of related trainings. -
After Go Live activities
After Validation Summary Report approval and Go Live has occurred, it may seem that everything about the Validation process is complete, but this is not true. The “validated” status must be maintained throughout the CDS utilization, including the proper management of changes and the proper verification of the system over time (system periodic review).
Conclusion
The CDS validation is an expensive and time-consuming activity, required by regulations, but one that provides positive improvement. A successful Validation process allows an organization to:
-
- Maintain or increase the regulatory compliance level,
- Identify issues at software level and recognize processes or specific configurations and restrictions to be applied/modified,
- Provide the possibility to review and optimize laboratory activities and processes to ensure greater efficiency.
