All posts by MikeWilliamson

Interested in collecting and analyzing data through software while travelling the world

Creating a User Requirements Specification (URS)

URS
Life without a good URS

Purpose of a URS:

  • Specify guiding regulations and industry and site standards the system must meet
  • Specify deliverables

Tips:

  1. Ensure each requirement has a unique number. This is for ease of traceability and referencing in other documents
  2. Evaluate the impact to quality in the URS itself. This will allow agreement up front for what requirements will need to be tested as part of qualification/validation, and which can be safety ignored.
  3. Each requirement should be specific and measureable so that it can be easily tested. While it’s tempting to include statements like “The XYZ system shall comply with applicable regulations” this statement really becomes meaningless because it is not specific enough, and is not testable. Continue reading Creating a User Requirements Specification (URS)

The Basic Validation Approach

Check

You need to understand your process, define what the acceptance criteria is, and then challenge the process. The idea is once you have a validated process, you don’t have to look at the acceptance criterion each time, just monitor that the process is under control.

Monitor process while performed under controlled conditions
Define successful results beforehand
Challenge the process
Determine efficient ways to monitor the successful process
Document the process testing

Qualifying cGMP Warehouse Space

Warehouse

Hello, good people of the world! So you have a cGMP warehouse you need to qualify? Well, this post will provide plenty of information to get you started.

First, how do you know your warehouse is a “cGMP” warehouse. Well, it is if:

  • The warehouse will house any raw material, excipient, intermediate, or finished product
  • The warehouse will house equipment or process consumables, such as filters, bags, disposable tubing, etc.
  • Any cGMP operations will occur in the warehouse, such as sampling, dispensing, kitting, track and trace, etc.

Any examples of common or even possible non-cGMP warehouse space in the Biopharma industry? Please leave a comment below.

Continue reading Qualifying cGMP Warehouse Space

Welcome to Mike Williamson Validation

Welcome good people of the world! Whether you’re an Engineer at a pharmaceutical company, a Quality representative in Biotech, or just someone interested in learning a bit more, you are making the world a better place.

Commissioning, Qualification, Verification, Validation – what does it all mean?

This blog contains FREE INFORMATION – always and forever.

I have over 10 years of validation experience, and am here to share what I’ve learned and to learn from you – please comment!

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