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Lexi Sharkov07/09/243 min read

3 ways an eQMS keeps CROs and CDMOs audit-ready

It’s the night before an audit. Is your team: A) frantically searching for training records, double checking SOPs across multiple sites, and tracking down last minute signatures; or B) sleeping soundly knowing everything is where it needs to be?  

For CROs and CDMOs that face frequent audits from sponsors, clients, and regulatory bodies, anything other than Option B means a lot of sleepless nights for your Quality team. 

What is audit-readiness?

“Audit-ready” means an organization is fully prepared to host an external inspection or audit at any time with very little notice, and is confident that it will meet or exceed the auditors standards.

That makes staying audit-ready priority number one for these life sciences contractors. When dealing with teams and sites spread around the globe, “audit-ready” can seem like an impossible standard… unless your Quality team has the right tools. Here’s how an eQMS makes it easy for CROs and CDMOs to embrace audit-readiness.  

Maintain version control across all sites 

It’s common for CROs and CDMOs to have sites in multiple locations, sometimes spanning across several countries, each with its own regulatory requirements and Sponsor/client needs. It’s also common for a rogue, outdated SOP to be floating around one of those locations if the organization is still using paper or spreadsheets to manage Quality. Manual systems like these might require someone on the Quality team to drive from site to site to collect old documents and replace with updated versions, or put the responsibility (and risk for error) on site teams to toss out retired documents. 

An auditor wants to see that every site has access to only the most current, approved versions of documents, whether those are clinical trial protocols, SOPs, quality manuals, manufacturing procedures, or anything in between. That’s where an eQMS shines. With an eQMS, all documents are stored in one location and can be updated or retired with a few clicks, making sure everyone has access to the most accurate version. Plus, it’s easily searchable, which means every document is exactly where you need it, when you need it. 

Manage – and prove – training compliance for a dispersed team

A quickly growing team spread across global sites is nightmare fuel for Quality teams tasked with training management on a manual Quality system. When you have to assign, track, and most importantly, prove every person is trained on Sponsor protocols across all sites with nothing but pen, paper, and Excel, staying audit-ready can feel like a pipedream. 

An eQMS takes this herculean task and automates it. Training can be assigned by group and reminders are sent automatically, empowering Quality leaders to keep teams compliant at all times, not just in preparation for an inspection. And when a Sponsor or client asks to see all training records on a specific SOP, an eQMS means real-time reports can be pulled at an audit’s notice. 

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Make change actionable and trackable 

Whether it’s a product’s design, a clinical protocol, or a manufacturing process, change happens. And auditors want to know all about it. 

An eQMS makes it easy to document who made the change, when it happened, and why – all answers you’ll appreciate having at the tip of your fingers when the inspector arrives. As an added bonus, managing change controls in an eQMS ensures users follow your defined workflow for documenting and approving changes. With a controlled system, nobody can skip a necessary step, so you always have clear evidence of compliance and proper change management. 

And it’s not just the Quality team that will appreciate the perks of an audit-ready eQMS. It’s also a breath of fresh air for inspectors who vastly prefer looking at easy-to-read reports and audit trails over sifting through stacks of paper or mind-melting spreadsheets. 

But above all, audit readiness isn’t only about passing inspections – it’s about establishing a culture of trust, efficiency, and compliance that spans the entire organization.