Computer System Validation
While you take care of your business and implement the software, we validate your computer systems. Our knowledge and experience have helped customers assess and define their validation requirements, especially producers of pharma products.
We pride ourselves in efficient and on-time deliverables of high-quality projects that are compliant with Computer System Validation regulatory requirements. Our highly skilled professionals are committed to providing excellence in helping you streamline your business.
Why should you go for Computer System Validation?
Production procedures, lab systems & devices, quality structures, and so on that might be being managed or supported by a pc system must comply with stringent policies and regulations to maintain reliability and records integrity.
Lack of validation might lead to deviations in the latter stages of the project. Validation gives documented proof that the system complies with the regulations during its lifecycle.
We Specialize In
- Automated Manufacturing Equipment (PLC / DCS / SCADA)
- Line Automation (PLC / DCS / SCADA)
- Process Automation Systems (PLC / DCS / SCADA)
- Asset Management Systems
- Building Management Systems (BMS)
- Environment Monitoring Systems (EMS)
- ERP Systems
- Laboratory Management Systems
- Document Management Systems
- Quality Management Systems
Rich Customer Portfolio
We have performed computer system validation (CSV) for many leading pharmaceutical companies. As a result, we have gained valuable customer insights to assist you at every turn of the road.
Entire Product Lifecycle
We provide across the board CSV services, including GMP Compliance Services and Validation Services. We’ve got you covered even if you need integrated services of both.
Backed by years of experience, our team specializes in helping life science companies to get the best out of validation efforts by performing best-in-class validation services through the latest technology.
Reduced Validation Time
We perform validation services keeping your short-term as well as long-term interest in mind. Our years of experience enables us to perform validation in the optimal time.
Wide Range of Systems
Our computer system validation services help you stay compliant with a wide range of computer systems such as ERP, LIMS, LIS, EDC, eQMS, laboratory instrumentation, and other business information systems.
We make sure that your computer systems are in accordance with regulatory requirements and industry standards – including 21 CFR Part 11 (Part 11), cGMPs, GLPs, and GCPs. You can rest assured whether you want us to follow your internal procedures or implement your own.
Our GAMP 5 Computer System Validation Includes
- Computer System Master Validation Plan
- Validation plan
- Gap Analysis & Risk Assessments
- Installation & Operational Qualification.
- Traceability Matrix.
- Related SOP’s.