Electronic Records and Electronic Signatures

We can help ensure your systems comply with the latest guidance and regulations for electronic records and signatures. Whether it is working with your own internal ERES Compliance and Assessment process or, through our own ERES and 21 CFR Part 11 Control Framework.

We can help you in the implementation project management and deliverables production including:

• ERES / 21 CFR Part 11 Compliance Assessment
• Specification of Risk-based ERES Controls Tailored to suit your organisation
• Integration of Controls with System and / or QMS Documentation
• Remediation Plans and Remediation Management
• Compliance Reporting