Unit 4 assignment D
GSK or glaxosmithkline is one of the largest pharmaceutical and healthcare companies in
the world. GSK focuses on developing, researching, manufacturing and marketing many
pharmaceutical products, vaccines and consumer health products. GSK works in a number
of medical areas including cancer, HIV, respiratory/immunology, infectious diseases and
oncology. They spend a lot of their money on research and development to find and create
new medications, conduct clinical studies to determine the effectiveness and safety of their
treatment and ensure regulatory compliance. In addition to medications, GSK also sells
consumer health products such as over-the-counter medications, dental care products,
dietary supplements and nutritional drinks.
How do they collect data on a day to day basis, how do they record each part?
● GSK collects data on a day to day basis through many methods such as experiments
and testing in the labs. Data is collected using the equipment from the laboratory
during the testing processes, these equipment often have digital screens that record
measurements and results automatically. Another way is through EDC systems. GSK
uses EDC systems in clinical trials and research studies to collect data electronically.
GSK may also collect data through clinical data systems to collect patient information
and medical data. This provides a thorough view of the patients health and helps in
analysing and research. GSK uses LIMS to manage and record data. They also use
standard operation procedures to record and collect data.
How are test results recorded, how do you know who did the tests and when?
● Test results at GSK are normally recorded using LIMS which is a laboratory
information management system. GSK uses this to record and manage test results.
The LIMS captures the data that laboratory staff and scientists enter into it which
includes test results, measurements, observations or other related information. GSK
also uses user identification and timestamps to record test results. By allocating user
identifications, the LIMS keeps track of who is doing tests. In addition, the
timestamps are kept to show when each test was run and when information was
input into the system therefore, responsibility and traceability are guaranteed
How is information about a certain sample made traceable so that the information can be
found again?
● To make sure that the information about a sample is traceable, GSK assigns a
unique identifier to each sample, this could be in the format of a barcode or sample
number at the time of collection. This unique identifier is used in the testing process
and is linked to the data in the LIMS. Each sample has a chain of custody maintained
by GSK that details its transfer across other laboratories as well as its transportation
and storage conditions. This guarantees the accuracy of the sample and makes
tracing easier. Additional data that the LIMS records includes timestamps, user
identification and any changes made to the sample. These records offer an overview
of the actions performed on the sample, allowing traceability and data integrity to be
maintained.
, Describe the steps done in GSK from start to end
1. Collecting the sample: the samples are collected from research studies or clinical
trials ensuring that they follow the protocols and guidelines
2. Sample registration: each sample has a unique identifier and is then recorded in
the LIMS
3. Processing the sample and analysing it: the samples goes through steps such as
extraction and purifying
4. Data entry: the data is record as well as any observations and measurements in the
LIMS and it is then analysed
5. Review of the quality control: the recorded data is goes through quality control
processes to make sure that it is accurate and complies with regulatory requirements
6. Final reports: final test reports are created based on the recorded data obtained.
How would the information gained from testing be put into a document for further use?
● The information gained from testing at GSK can be shared both internally and
externally. Document generation is one of the external methods, the test results and
obtained information can be made into formal reports or documents using formats.
These documents can help identify important findings, interpretations or any relevant
data. Electronic systems is an internal method, GSK may use electronic document
management systems to store, shar and organise information. These systems enable
it to have an effective way of accessing and retrieving data
Why and how would GSK communicate internally and externally with other companies?
● GSK communicates internally with other companies, laboratories and regulatory
bodies to guarantee efficient coordination, collaboration and compliance throughout
the company. This includes coordination between the production, quality control,
logistics and regulatory affairs departments as well as those involved in
manufacturing, testing distribution. GSK communicates externally with companies,
laboratories and regulatory bodies. This includes communication with other
laboratories for joint research projects, with businesses for supply chain management
and with regulatory authorities for reporting, compliance and approvals. Internal and
external methods of communication can include hosting or attending
meetings/conferences, email, video conferences, messaging, publishing scientific
papers/reports, clinical trials results, formal submissions, press releases and
interviews.
Why and how would the NHS blood pathology lab communicate internally and externally with
other laboratories, companies and regulatory bodies?
● The NHS blood pathology lab internally communicates with other laboratories and
companies to coordinate testing procedures, share test findings and guarantee
effective operations. Communication takes place between pathologists, lab
technicians and other staff members engaged in sample processing and reporting
and analysing. The NHS blood pathology lab communicates with other labs
externally to refer samples, do follow up tests or exchange findings and information.
Furthermore, interaction with regulatory organisations guarantees compliance to
requirements for quality and safety. Collaboration with other pharmaceutical
companies for research or clinical trials are also another way of external
communication. Internal and external methods include electronic communication,
