GMP lab working with clients
Your lab is similar to this scenario:
Your lab performs qualitative and quantitative analysis of different samples, optimizes and develops analytical procedures, and validates analytical procedures for different pharmaceutical companies. Analyses are performed within requirements of good manufacturing practice (GMP) and in agreement with certain ISO standards such as ISO 17025. Such companies may also have other departments that are not regulated and are much more flexible in their use of an ELN. Analyses can be performed for either in-house purposes or for customers.
Size: You are a medium sized lab within the larger organization.
Keywords describing the example: QMS, quality assurance, process, SOP, regulated, ISO, ISO 17025, GxP, GMP, E-signatures, audit trails, 21CFR part 11, Annex 11, task status
Suggested SciNote structure:
For you, the team is your lab team, your department.
The name of the project can be Client 1 – the name of the client i.e., client’s organization. This is useful if you want that different client’s data is separated. For example, Client 1 – Analytical procedures (APs), Client 1 – Protocols, Client 1 – Change control, Client 1 – out of specification (OOS) investigations etc.
For example, an experiment can be the name of the form for change control management e.g. Form Number XY (example before SciNote: change control management would usually be recorded as a physical list of changes, then completed, converted to pdf, signed electronically and manually stored to the server).
Module 1 (change proposal process and electronic signatures), Module 2 (change finalization process and electronic signatures). Another example here would be tasks connected in a workflow that represent the entire process of investigation of OOS results.
To sum it up, your SciNote structure could be
Team 1: Your department
Project(s): Client 1 – change control management; or Client 1 – analytical procedures
Experiment(s): Form Number XY; or Analytical procedure 1; OOS investigations
Task(s): Module 1 (change proposal process), Module 2 (change finalization process); or Analytical procedure 1 protocol; or OOS 1, OOS 2, …
Examples of additional functionalities that are helpful:
Using the electronic signatures, the authorized person can approve, sign (or even reject) a suggested form that is in review. In SciNote, requesting the approval or requesting the signature is easy, and more than one person can sign if there are multiple levels of supervision in the lab.
SciNote enables audit trails to independently record the date and time of each user’s entries and actions. The audit trails cannot be edited or deleted.
Inventories in SciNote are lists (repositories, libraries) of whatever you need e.g. files, samples, equipment, reagents or something completely different. They are completely editable so your columns can contain names, ID codes, barcodes, files, dates and more. You can always add a new item to the inventory and then assign it to the task within the experiment. This means you will always have the full history of what has been done with each inventory item, one click away. If you want an organized list of all forms for example, you can use the inventories for that as well. Each item can have its ID, name, the associated file etc.
If your QA instructions and processes are written as SOPs or protocols to follow, they can be saved within the protocol repository. You can create different versions, and use a protocol as a template to create a new one. All activities related to each protocol will be recorded (date/time of modification, user who made the change etc.). You will also be able to see which projects this particular protocol has been associated with.
If your client requests a similar experiment, or the same one within the different time frame, you can copy the experiment as a template and reuse it, or copy one or all tasks as templates.
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