Validation Services

Overview

The UCA Validation Services Practice is focused towards helping you manage the IT validation/Quality Assurance activities that support your IT/business functions in a regulated or non-regulated environment. These are the broad areas of service that your organization will benefit from:

IT Validation

Validation of computer & computerized systems
21 CFR Part 11 Support
Training

Quality Assurance Support

Quality/Compliance Auditing
Compliance Appraisal
Quality Project/Process Management

Services

The practice has in-house resources that specialize in validation of computer and computerized systems, general PLC validation, system/software upgrade qualification, Part 11 Assessment, Part 11 Gap analysis, and Remediation of systems for Part 11 Compliance. You will benefit from our services specifically in the areas of:

Validation/Quality Planning, Execution, and Reporting
21 CFR Part 11 Assessments, Gap Analysis, and Remediation
Appraisal of Systems for Regulatory Compliance

Quality Project/Process Management
Quality/Compliance Auditing
On-site Training on Computer System Validation and Part 11, and related governance processes

Industry Experience

Whatever the size of your firm - large, medium, or small – you can benefit from our services. UCA has had the privilege of accruing a wealth of business, Information Technology, and validation because of the opportunities provided to us by our customers. Our industry experience in the area of validation is made up of:

Business expertise: Extensive knowledge base derived from many years of successful delivery to a diverse clientele within the life sciences industry; working knowledge of GCP, GMP, GLP, and GAMP.
Systems Expertise: These are the systems that our clients have engaged us for, but not limited to: clinical data acquisition and management systems, statistical reporting systems, manufacturing and laboratory systems, health and safety management systems, medical dictionaries, instrument interfaces, networking systems, database systems, and operating systems.
History of reliability: Credentialed customer references on the services that our customers have engaged us in, since our inception in 1996. Our clients have benefited from our capabilities and assistance in establishing effective processes to meet their validation/QA goals.