AG5 for medical manufacturing

Ensure your team is FDA audit-ready with accurate skills tracking

Our skills matrix software tracks all your employee skills and certifications down to the task level of your production process.

  • Proactively address skill gaps to maintain compliance
  • Generate real-time, accurate reports for stress-free FDA audits

Loved by training and quality assurance teams

ArcerlorMittal logo

Struggling to track employee skills against thousands of production tasks to meet FDA requirements?

There are too many requirements and employees to keep track of in Excel.
You can’t figure out what additional training is needed across your workforce.
You’re scrambling to accurately document personnel skills data to the FDA.

Let AG5 ensure your workforce meets every FDA personnel qualification

Map employee skills to every task of the production line

AG5’s skills library helps you track all production line requirements back to the needed skill — so you can be confident your skills data is accurate and in compliant with FDA guidelines.

 

Instantly identify where training is needed across your workforce

Our skills gap alerts give you and your employees advanced notice when employee certifications don’t match production requirements — so you can proactively train specific employees to address skill gaps.

 

Generate accurate reports on employee skills and certifications for FDA audits

Never again scramble to document your employee skills data for compliance audits.

AG5’s report builder lets you document your personnel and training data for FDA reviews in a few clicks.

 

Features built specifically to meet FDA requirements

Audit Trails

We automatically timestamp and document the history of all data changed — so you can meet the FDA requirements for accurate record-keeping and data traceability.

Data Management Approvals

Establish multi-person workflow approvals for confirming and updating production records — so you can meet FDA requirements for data accuracy and change management.

Data Authorization

Setup two-factor authentication for approvals and data updates to ensure data integrity and enhanced access controls.

See how we’ve helped medical manufacturing companies like you

Francois van Baal
EHS Training & Compliance Coordinator

“It saves a huge amount of work, both for me and for the employees. They can independently determine when to complete the training required to continue their certification.”

Danny ten Veen
Coordinating Analyst

“We conduct medical research here at LabPON, so if something should go wrong, we need to be able to show that the person responsible was indeed qualified to be performing the task in question.”

See how AG5 can keep your workforce compliant with FDA

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