Computer System Validation Biological & Biomedical Sciences Coursework (Coursework Sample)
I have attached a report that I have started on but and I am just looking for 1000 new words. I am paying extra for the following;
What I have there to be paraphrased. All that is highlighted in yellow is direct quotes from notes so just need this paraphrased and other references doted around the report. Information can be taken out if needed.
Content page required
10 new referenced from reliable sources.
Any questions please let me know.
CHROMATOGRAPHY DATA SYSTEM (CDS)
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).
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