Compliance with FDA 21 CFR 11 Electronic Records; Electronic Signature and EU Annex 11 Computerised Systems is a must for the pharmaceutical, biotech, medical device, and clinical research industries. Whether your organization makes regulated products, conducts clinical trials, or provides software to these industries, we can bring your processes and systems into compliance.
Get Part 11 and Annex 11 Compliant
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 the activities involving GxP systems, such as back-up, disaster recovery, security, access management, risk assessment and management, change control, validation, issue management, and record retention.
We develop the Standard Operating Procedures (SOPs) to meet regulatory requirement and incorporate industry-standard practices, but also ensure that the SOPs 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 can work with you to develop a risk-based methodology for your first validation project or bring and older validation package into compliance with modern standards.
Training
From free webinars to week-long, hands-on class, we have 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 just the right amount of training for every level of your organization.
