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Compliances & Validation

In Order To meet and mitigate regulatory risk United Techno offers a broad array of quality compliance and validation services, ranging from risk assessment and hardware/software qualification to full system validation and revalidation.

Whether you have limited in-house expertise, a validation plan that must be adapted to your current processes, or if you simply want a fixed-price plan to help ensure your regulatory requirements are met at installation and during operation, United Techno’s compliance team is available to help. We can help control your validation costs, and minimize the frustration and burden of developing and maintaining compliance and change control.

Our Compliance and Validation Portfolio includes

1. Document Management Systems - Store, manage and publish quality documentation (e.g. SOPs, validation documentation, etc.) in accordance with GxP regulations.
    a. Implementation Services
    b. Validation and Change Control Services

2. Exception Handling and CAPA Management
    a. Manage and Support handling of exceptions, deviations, complaints, audit findings, etc.
    b. Manage and Support registration and monitoring of corrective and preventive actions

3. Training Management - Support and Validation Services
4. Change Management Systems – Validation and Maintenance
5. Enterprise Compliance

SAP Pharma FDA Validation

United Techno recognizes the need to validate regulated systems cost-effectively, efficiently, complying with regulations, and by satisfying all 21 CFR Requirement. Computerized systems or software that performs GxP related functions in the life science industry must be validated. Computerized systems may include – automated manufacturing equipment, control systems, automated laboratory equipment, laboratory data capture system, manufacturing execution systems, computers running laboratory, clinical or manufacturing database systems, and any interfaces to other GMP Systems. United Techno’s Capabilities cover the full range of FDA Compliance needs: 21 CFR Part 11, Part 210/211, GAMP5, Part 320/820, and across the entire spectrum of CSV, GMP, GLP, GCP, GDP, GxP, ICH, CQV, equipment, facilities, process, cleaning, packaging.