Sebald Consulting can perform gap analyses to help you meet compliance requirements for GMPs including quality systems, calibration and maintenance management, validation, software and system development lifecycles, etc. We can also help you put systems in place to remediate potential problems.
Implementation of cGMP systems is highly dependent on early training, planning and configuration. Simplify your work and reduce your exposure with good training.
We can provide training to automation and software developers to help them comply with new requirements generated by cGMPs, 21CFRPt11, GAMP 5, and other sources commonly reference by your potentials customers.
If you are an end user, we can help you achieve documented compliances with FDA and EU requirements.
Other areas of expertise include:
- cGxP Control System Development
- Root Cause Analysis (RCA)
- Building Automation Systems (BAS)
- Building Management Systems (BMS)
- Computer System Validation