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BTEC Science Unit 4 aim D
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BTEC Applied SCIENCE 2A P1COURSEWORK
Habib Garrouch Year 12
Mr Ambrose
Unit 4 Assignment D:
Understand how scientific information may be stored and communicated in a workplace
laboratory:
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Brief Introduction:
I work as a laboratory technician for a pharmaceutical business that is researching new
pharmaceuticals. The organisation protects the privacy of its employees and volunteers. My
task is to evaluate the challenges of storing and transmitting data inside a lab.
AstraZeneca, the firm for which I am presently employed, is a Public Limited Company
(PLC). AstraZeneca is a British-Swedish pharmaceutical business that was created in 1999
"by the merging of Swedish Astra AB and the British Zeneca group"[2].
P7 - Explain how scientific information in a workplace laboratory is recorded and processed,
to meet the needs
of the customer and to ensure traceability:
Laboratory information management system (LIMS):
During the course of the laboratory work, a large amount of information would be generated
(AstraZeneca). It is critical that data be stored in a fashion that permits it to be accessed at a
later period. Now that technology is getting more prevalent in the sector, you will no longer
see vast numbers of boxes or file cabinets stuffed with paperwork because all information
and data are maintained on computers. Organisations frequently purchase secure cloud
space to guarantee that data is not lost.' [1]. There are several benefits to using cloud
storage and computers, one of which is that the "amount of space required for computer
storage is substantially smaller than the space required for paper storage." [1]. Large heaps
of paper may provide a fire risk. It is easier to search for records when they are kept on the
appropriate cloud rather than digging through vast mounds of paper.
,There are several sorts of data that must be saved in a laboratory environment; for example,
data regarding staffing levels, personal data about members of staff, and data about
equipment or supplies that have been used. Different forms of data will need to be properly
maintained in order to be kept safe, secure, and accessible at a later point. Now that many
organisations utilise computers to handle or store personal information, there is a risk that
the information will fall into the wrong hands or be exploited. Many organisations are
accountable for knowing how accurate the personal information is, if it has been duplicated
by someone else, and who has access to this information.
6 key objectives of the LIMS software:
A LIMS (or Laboratory Information Management System in its full form) helps in three main
ways: Accuracy – A LIMS helps labs produce accurate, repeatable results, Efficiency – A
LIMS helps labs to automate and speed up laborious tasks, and Management – A LIMS
helps labs store and retrieve results quickly. LIMS software helps labs meet regulatory
requirements such as GMP, FDA 21CFR Part11, GLP by encapsulating what they do and
how they do it, enabling efficient management of the lab.
5 Key Phases of a Clinical Trial
Step 1: Discovery and Development.
Step 2: Preclinical Research.
Step 3: Clinical Research.
Step 4: FDA Drug Review.
Step 5: FDA Post-Market Drug Safety Monitoring.
The Volunteer sends a medical questionnaire. The questionnaire with responses to
fundamental, personal, and health questions is the data generated for Phase 1. During
Phase 1, questions and responses are written down on a piece of paper. The data from the
paper is thereafter converted into a Microsoft Excel database so that the Technicians
working in the scientific Laboratory may interact with one another on a regular basis.
What is a Phase 5 clinical trial?
A Phase 5 Clinical Trial is a post-registration clinical trial that is not needed as a condition of
obtaining or maintaining Marketing Approval, Pricing and/or Reimbursement Approval for a
Licensed Product. Post-marketing clinical studies are another term for Phase 5 clinical trials.
How is scientific information in a workplace laboratory, recorded and processed?
What is laboratory data collection?
LEAF contains spreadsheet-style data templates that enable laboratory employees and
project managers to record and preserve data obtained during LEAF leaching tests in the
same file as analytical data for each extract or test fraction.
The 10 types of data in a Workplace Laboratory:
1)Control of Substances Hazardous to Health (COSHH) records;
2)Scientific data;
3)Scientific apparatus;
4)Waste disposal;
, 5)Health and safety checks;
6)Training records;
7)Quality assurance;
7)Report records;
8)Specification levels;
9)Sample throughput;
10)Management;
1) COSHH Records are kept in labs to keep information about the compounds that must be
used carefully in studies in accordance with Health and Safety Legislation Laws. Technicians
working in the Workplace Laboratory keep COSHH records. These technicians have the
ability to modify the records.
How does a barcode system work to track data entry in a LIMS?
Information can be uploaded into the LIMS by uploading files created by laboratory
instruments, or by registering samples and creating text and graphical documents containing
information or analysis results. A portable device can also be utilised to enter samples and
data into the management system.
Why does it make sense to use a barcode system rather than manual data entry?
First, the sample container is recorded in the LIMS before being transported to the customer
to collect the sample from the client. When the sample arrives at the laboratory, the
registration procedure begins, which involves printing barcodes to embed in the sample and
use to keep customer and practitioner information. The LIMS barcode system is also used to
track the chain of custody and sample location, which includes the process performed on the
sample and its storage location (the freezer, shelf, rack, box, row and column).
What procedures would be necessary for tracking the sample, procedures and results?
One of the most serious and prevalent issues in a laboratory is the doctor's name. During the
registration of a sample in the LIMS, the practitioner's name and contact information, the one
who requests the lab analysis, are frequently lost. This creates future communication issues:
if the sample yields dangerous results, the doctor must be alerted quickly. As a result, basic
information such as the practitioner's and client's names and phone numbers must be
supplied. Background information about the patient's life and situation should also be
included with the sample.
The sample must be handled with care during the processes since it cannot be
contaminated in order to offer clear findings. The barcode system is essential at this point
because the analysis must be connected to the sample to avoid mixing information with
samples from other clients. Following the processes, the test results must be entered into
the LIMS utilising the barcode system and communicated to the client.
What does GDPR stand for?
General Data Protection Regulation
What is the GDPR Act?
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