Before beginning any of the phase testing, it was important that I knew about
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Before beginning any of the phase testing, it was important that I knew about correct documentation practice that is the standard in Zenith. The main guidelines that are necessary for Good Documentation Practice (GDP) were as follows:
1. Document entries shall be readable, accurate, complete and done in blue permanent ink. The reason it must be blue ink is that when the documentation is scanned blue ink can be differentiated immediately by colour from the black print text. Any highlighting of text must be conducted using a yellow highlighter.
2. All entries shall be recorded as soon after the event occurrence as possible. Entries shall only be dated with the current date; back dating and forward dating are considered…show more content… Below is an image of what the folder cover and spine looked like.
These boxes were then placed onto a pallet and wrapped in cling film; they were then secured with plastic straps to prevent movement during shipment. Once this was complete the address that it was being shipped to had to be stuck on all 4 sides using labels and a plastic pouch containing a transmittal document to be signed by the recipient which contained the contents of the pallet.
The reasoning behind this attention to detail is:
• Professional presentation
• Clear and Concise
• Requirements for Audits (FDA etc)
2.4.1 GAMP5 V Model
The GAMP5 V model is a model for all business’ to adhere to when completing a project, if specified by the client. Figure 6 below shows this model. When a client issues a tender for a project, a User Requirements Specification (URS) is usually issued
This URS is required before the system software documentation is generated, it outlines requirements such as functions and workflow that the system must be able to perform, the type of information that a system must be able to process and how the system will be maintained and users trained. Once this is approved a Functional Specification (FS) is drafted which outlines how the equipment/system will meet the URS. Once this is approved then a Design Specification (DS) drafted, which outlines information about the project and how the project will be executed.
All of the documents issued by the client and