QUALIFICATION | DOCUMENTATION

Havcom Technologies is the industry leader in validation/ qualification services. Our experienced validation/ qualification team will document the consistency, quality and accuracy of your systems, methods and processes. We understand the various validation/ qualification requirements for Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP) and Good Clinical Practice (GCP) systems and the best ways to ensure compliance with FDA, EU and other global regulations. We can follow your validation/ qualification procedures or assist your company in creating a suitable process.

Based on the deep expertise gained over years and the rich experience gained in various qualification projects, Havcom Technologies provides efficient qualification services including development of qualification strategies and plans, creation and execution of Installation Qualification (IQ) / Operational Qualification (OQ) / Performance Qualification (PQ) test results. Each qualification assignment includes documentation, design of traceability matrices and distribution of a comprehensive summary report.

Validation Engineers, Subject Matter Experts and Validation Managers of Havcom Technologies work closely with the client business and technical project leads to define an implementation plan and schedule, including resource requirements from the customer, and change management processes. All specific risks are identified and appropriate mitigation plans are documented.


The highly experienced team of Havcom Technologies provide the technical expertise and project management capabilities needed for successful qualification. The proven methodologies followed by Team Havcom ensure successful project execution by employing industry latest and best practices. It reduces time, minimizes risk, and ensures that our services are provided to meet your needs.


"We explore, we update; we make you strong; We are Havcom – Complying Regulatory Needs"

EQUIPMENTS VALIDATION

Equipments qualification includes a range of qualifications such as Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), which leads to a high level of assurance of the consistent, expected functioning of control system of equipments. Documentation of operating parameters and environment, as well as routine maintenance and on-going performance checks, contribute to a life-cycle approach to maintaining equipment in a valid state.

Havcom Technologies provides qualification Services for PLC, HMI, IPC and other such equipments.

MACHINES VALIDATION

Machines validation including Computer system validation (CSV) documents that the machine meets a set of defined system requirements. Validation of computer systems to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid records is a critical requirement of electronic record compliance, as per FDA 21 CFR 11.10(a) and EMA Annex 11, Section 4.

Validation is more than a compliance requirement. Pharmaceutical computer system validation is a unique methodology for businesses to scrutinize their computer systems to enhance effectiveness and quality.

SOFTWARE VALIDATION

Computer Software Validation is a documented process for testing computer software and systems. The FDA and other regulatory bodies require validation to demonstrate that computer systems are in compliance with all regulations for electronic data management systems.

Team Havcom can validate all of your software, databases and spreadsheets. We develop the appropriate documentation for all phases of the software life cycle. Our validation methodology ensures validation deliverables. We address the most critical system functions, and complete the validation projects effectively.