Creating a User Requirements Specification (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.

The Basic Validation Approach

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

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.

Deviations, Discrepancies, Variances, Exceptions – You Know You’re Gonna Have ‘Em

So what do you do? I hope you already have a SOP to handle these. If not, let me get you started!

HOT NEW TREND: Risk-Based Validation

Risk Management Options

IQ, OQ, PQ – Where Did These Terms Come From?

The ISPE Guides – How Useful Are They?

Welcome back good people of the world! If you’ve been in “the industry” long, you’ve surely run across ISPE and maybe you’re even a member. I’ve been a member most of my career but don’t have any other strong affiliation, and feel like I talk about the group in an unbiased way.

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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