Montrium

The quality buffs out there will get it:

It’s easy to go off the rails with change controls.

But we’ve got you covered.

Keep your peace of mind and steal our change control process cheat sheet. 👇

Stop underestimating your TMF.

We know, it’s easy to get in the habit of filing away documents until it’s inspection time.

But the TMF is more than meets the eye.

And it deserves to have proper processes in place to deal with the fundamental documents within it.

Which processes does your organization have in place to help manage the TMF? Let’s chat below!

Assessed a vendor to be medium or high-risk?

It’s time for an audit.

Here’s a quick guide to help you develop your own internal audit program—from creating the plan to beginning the follow-up process after the report is written.

Vendor risk assessments don’t have to be complicated.

In fact, the best way to conduct vendor risk assessments is to be as pragmatic as possible.

Don’t get bogged down by creating unnecessary categories and complex scoring conventions. Steal this vendor risk assessment template developed by Maria Veleva of Velev Consulting.

What’s your quality system going to look like?

When fleshing this out, it’s vital to remember these 3 components.

🗂️ Structure: How do you want to organize your policies and procedures? What is your hierarchy?

👩‍💻 Key roles: Who will be performing the tasks and actions? How will you identify the roles (job title or generic role)?

📝 SOPs: What will your SOP structure look like? Think: naming and numbering conventions, templates for each document type, and formatting requirements.

What’s your experience with building quality systems? Did we miss anything? Let’s chat below!

There are A LOT of moving parts in a quality system.

Having a holistic, bird’s eye view of the system will enable you to promote proactive, data-driven decision making and better support your organization’s quality culture.

Here’s what that single source of truth should look like:

To all the biopharmas getting started on your quality journey, you’ll want to read this.

Do you ever find yourself wondering:

“How am I going to develop the key processes that will give structure to my organization?”

If you said “yes,” the best place to begin is with process lists.

We’re sharing our cheat sheet on process lists to help you get started.