System Compliance
Part 11 and Annex 11 contain very specific functional requirements for regulated systems. Our consultants work side-by-side with your technical experts to determine the system configurations needed for compliance. When systems require customization, we review the designs to ensure that the end result will be compliant from the first release.
Process Compliance
Regulations require procedures for activities involving GxP systems, such as:
- Back-up
- Disaster recovery
- Security
- Access management
- Risk assessment and management
- Change control
- Validation
- Issue management
- Record retention
We develop Standard Operating Procedures (SOPs) to meet regulatory requirements and incorporate industry-standard practices, while ensuring they are tailored to your roles and responsibilities, technologies, and QMS infrastructure.
Validation Compliance
Computer System Validation? Computer Software Assurance? The terminology can be intimidating, but we have the experts.
Our consultants work with you to develop a risk-based methodology for your first validation project or bring an older validation package into compliance with modern standards.
Training
From free webinars to week-long, hands-on classes, we offer a full suite of training in Part 11, Annex 11, Validation, and Data Integrity.
Check out the options here, or contact us to develop a program with the right level of training for every level of your organization.
