Our experience spans the range from system-specific projects to enterprise-wide endeavors. 21 CFR Consulting’s dynamic approach allows for different engagement models:

Gap Assessments & Remediation
A Gap Assessment is a predetermined evaluation of a company's current quality management systems to determine what would be required to bring the company into compliance with the applicable government regulations and industry standards. The assessment reviews the present policies, procedures, level of expertise, systems, and equipment. During a gap assessment, we are cognizant of the compliance requirements and can adjust the assessment to ensure all applicable regulations and standards are met.

Risk Assessments
Validating computerized systems is time consuming, expensive and resource intensive, all size companies are challenged to identify and prioritize the validation of their systems. After performing a Gap assessment and making recommendations for remediation, we will work with you to create a risk assessment of your systems.

Network Infrastructure Qualification
The network infrastructure is the backbone of your networked systems. Like all computerized systems, it must be tested to demonstrate it's suitability for your intended use. Network infrastructure, PC hardware and operating systems should be qualified; systems and applications running on a network should be validated. 21 CFR Consulting will work with you to document your network, as well as plan and execute the qualification package.

System Validation
For a given computerized system, we ensure the creation of documented evidence, which provides a high degree of assurance that a computer system performs its intended functions accurately and reliably. 21 CFR Consulting can work independently or as a member of your project team following a predefined controlled lifecycle process that includes at a minimum planning, execution, documentation, and approval.

Training and Education
21 CFR Consulting's experts can work with you to create custom training sessions to educate your systems administrators, end users, and key stakeholders in everything from system specific daily operation and maintenance to the entire validation process.

Procedural Infrastructure
A system can only remain in a validated state as long as it is supported and maintained. 21 CFR Consulting can work with you to create the necessary policies and procedures as well as provide the ongoing validation support and maintenance for your systems as they undergo enhancements and changes.

Whatever the size and scope of your compliance efforts, with the professional, results oriented 21 CFR Consulting team as a member of your compliance team, the end product will be an FDA compliant environment that provides real business value.