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We at Valisurance, provide validation services for COTS and Bespoke IT systems, IT Infrastructure of manufacturing, laboratory, Research and Development units of pharmaceutical industries, this is done by our team of experts and skilled consultants.
We follow a risk-based systematic approach advocated by ISPE GAMP5 and FDA's. We support pharmaceutical companies by providing the end-to-end validation solutions needed to achieve and maintain regulatory compliance.
Enterprise Systems
Enterprise Systems
For any industry, enterprise systems are valuable asset and need to keep them always in validated and compliance state.
There are some common enterprise applications such as, but not limited to:
Systems, Applications & Products in Data Processing (SAP)
Quality Management Systems
Document Management Systems
Laboratory Information Management Systems
Training Management Systems
Document Management Systems
SaaS applications
Bespoke IT systems and platforms built using cloud services
We help our clients to meet regulatory expectations from conception to go-live for smooth operation of their Enterprise Projects.
Manufacturing Systems
Manufacturing Systems
Manufacturing systems and processes are very critical for any pharmaceutical industry in order to achieve regulatory approvals and business scalability.
In order to get a regulatory approval, these systems needs to be in compliant state throughout the life cycle.
We provide a scalable and pragmatic lifecycle validation solution to save time and increase productivity with a seamless manufacturing process.
Laboratory Systems
Laboratory Systems
Laboratory Systems play a pivotal role in developing new drugs, testing product safety and efficacy, optimizing manufacturing processes, and conducting investigations when issues arise.
Validation of laboratory systems in the pharmaceutical industry is crucial for ensuring reliable and accurate results in testing and analysis. It is also essential for regulatory compliance, maintaining product quality, supporting research and development efforts, and ensuring the safety and efficacy of pharmaceutical products.
We ensure Regulatory compliance by severing Strategic validation services from simple lab systems to complex integrated laboratory systems
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