Validation:

CADI is a global provider of clinical development, regulatory/validation consulting and medical communications services to the pharmaceutical and biotechnology industries.
Monitoring and consistently applying FDA regulations is not an easy task. CADI performs a number of services that will allow you to keep your applications in compliance with FDA regulations, and will keep you abreast of the latest developments in regulatory compliance.

21 CFR Part 11 Assessments:

CADI Technologies can perform a complete 21 CFR Part 11 assessment of your systems environment: identifying compliance gaps, developing a plan to bring your applications into compliance, and assisting with remediation efforts. We also offer a course to train your staff on 21 CFR Part 11 requirements.
Assuring compliance with 21 CFR Part 11 regulations requires examination and evaluation across systems, products, processes and functions within your organization. CADI has the perspective, objectivity, experience, expertise and services to help ensure your company's compliance.
Strategic Planning

CADI helps companies develop strategic plans for complying with 21 CFR Part 11 by:

. Providing regulatory requirements and applicable guidance policy training to
o Pre-Clinical and Clinical Research
o Clinical Data Management
o Regulatory Affairs
o Information Services
o Software Development
o Quality Assurance personnel

. Identifying the specific systems that fall under the scope of 21 CFR Part 11 and evaluating the potential regulatory issues for each

. Determining if existing policies and procedures are consistent with, and conducive to, developing and deploying 21 CFR Part 11 compliant systems

. Developing a remediation plan to address regulatory issues:
o stratification of systems according to risk
o identification of specific system issues and corrective measures
o establishment of roles and responsibilities
o determination of resource requirements
o creation of milestones and target dates.
Regulatory Auditing

CADI's audits help clients identify their specific areas of risk regarding 21 CFR Part 11 compliance of systems, procedures, documentation and controls. During the audits, we review applicable documentation, interview key quality assurance, support and management personnel, and address the following regulatory issues:

. Company organization
. SOPS, policies and guidelines
. Personnel qualifications and training
. System design and specification
. System development/implementation
. Testing
. Change control
. Quality assurance
. User documentation
. Installation and maintenance

A written report summarizes the audit results and provides the client with specific recommendations to mitigate any technical or regulatory risks discovered.

Implementation Assistance

CADI provides professional consulting and expert implementation assistance to help clients remediate any 21 CFR Part 11 regulatory issues:

. Validation plan development
. Education and training
. Documentation development
. Security reviews
. SOP development
. Test plan development and execution
. Quality assurance
. Development methodology review/evaluation
Other CADI's Services
. Validation Consulting Services
. Clinical Data Management Services
. Monitoring Services
. Information Technology Consulting Services
. Contract Programming and Software Development Services
. Patient Cost Analysis Services
. Document Management Consulting Services
. Needs Assessment Services
. Metrics and Best Practices Services
. Training and Documentation Services
Further information

To discuss your particular requirements, or for further information on CADI's services, please feel welcome to call us on 703-349-2263. Alternatively please email validation@cadi.com