Computer System Validation: Electronic Records

CHROMATOGRAPHY DATA SYSTEM (CDS)
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Chromatography Data System (CDS)
1 Identify and describe the typical business and GMP functions (20%)
Electronic records are essential in providing traceability, which play significant roles in business and GMP functions. HPLC is involved in retaining run-time data files, which result from approved analytical techniques. Some of the run-time data that requires recording are sample/standard sequences (analytical methods), detector conditions such as wavelength, column temperature, and solvent flow, among others. According to Gerladine (2020), chromatographic data is usually moved to CDS to facilitate data analysis and storage rather than being retained in the HPLC system. The records act as medium impact as it is the mandate of management to determine the final decisions. Design history file (DHF) describes a combination of files that tend to explain the history of finished devices (Marehn, Wilhelm, Pospisil & Pizzoferrato, 2019). The final device review will include concepts such as design identification, person and date of the review, and documented in the DHF (Aziz 2019). Any complaint related to an event is usually reported to the FDA under part803 or 804 (Aziz 2019).
A record is usually verified if trustworthy, depending on whether the systems can verify its integrity and authenticity after copying, transferring, migrating, or reformatting the record to ensure no alteration. In essence, it is necessary to consider the trustworthiness and integrity of a record when sharing information objects between several computing environments. More so, it is essential to consider the electronic record and signature vulnerabilities that tend to face each computing environment and the mechanisms that are essential in mitigating the threats (Gerladine, 2020).
It is essential to identify and document all records that have been regulated. A data flow analysis plays a crucial role in this process and helps determine each regulated record's role. It is possible to have electronic records that will be created and maintained in a single system while the electronic copies are moved and used by other systems. It is also necessary to ensure that all records meet the various GxP regulations (Bird & Dong 2019). Nevertheless, several electronic records, such as software code, internal system configurations, and technical parameters, do not need to be regulated.
Additional checks are usually done for all critical data that cannot be entered electronically or transferred among systems before processing it. This validation is usually performed by a second operator or through electronic means to ensure that no erroneous or incorrect data are entered into the system by other systems. It is also necessary to ensure that all records meet the various GxP regulations (Bird & Dong 2019). For one to access electronic data, they need to have a user-id and password or local PC security to gain access to the application.
2 Schematically represent typical architectural components (10%)
3
Schematically represent typical architectural components (Cortes et al., 2020)
4 Describe a general approach to achieving compliance and fitness for intended use over the entire lifecycle (50%):
1 Concept
2 Project
3 Operation
4 Retirement
A general approach to achieving compliance needed for the entire lifestyle has to consider the models available for compliance. A typical V model requires to be a computerized project. To begin with, the first phase of any project is planning whose completion is done by the end-user (Haarsma et al. 2016). The next phase is the specification process, whose completion is done by the vendor. Configuration and coding of the software are the next phases, which are also completed by a vendor. The next phase is usually the verification testing phase, whose completion is done by both the vendor and user. The first phase of any project is planning whose completion is done by the end-user (Haarsma et al. 2016). The last phase is the reporting phase, whose completion is done by the user. It seeks to illustrate that the system is appropriate for its intended purposes. To begin with, the first phase of any project is planning whose completion is done by the end-user (Haarsma et al. 2016). The V model seeks to ensure a connection between the planning and reporting phases while linking the specification and verification phases. In essence, the specification phase is where the software and hardware are configured.
Notably, the computerized system usually comprises four main phases:
Concept. This is where the systems' requirements, critical functions, and available hardware and software options are defined.
Project. The typical V model is used, and it will be used to control the project. The V model will be used in controlling various specifications and testing deliverables.
Operation. There is the capturing and controlling of changes as well as documentation of configured hardware and software platforms.
Retirement. The system's upgrading process involves focusing on the existing one and looking at what needs to be retained, m...