Our Documentation :
Our Protocols are based on GAMP 5 Guidelines. We are providing following Documentation.
- Computer System Master Validation Plan
- Gap Analysis & Risk Assessments
- Installation & Operational Qualification.
- Traceability Matrix.
- Related SOP’s.
Why Computer / PLC System Validation ?
Now a day Automation is gathering Complexity, Innovation, and Momentum, and we have to rely on it more and more. Pharmaceutical and Healthcare companies calling for investment in new technology to Improve Business Efficiency and Competitive Edge. When these systems are used for Production and Control of Life-Saving Medicines or Devices, we need to know that it is Reliable, Quality Assured, and Validated. To achieve this it is essentially require Computerized Systems to be Fully Documented, Defined as to Functionality, Quality Assured, and Validated.
When these companies invest in Computerized Systems, they expect it to be Installed & Commissioned as per Schedule & Cost. As these companies are Very Keen to place New Products and Versions on the market In Time, in this process many times it becomes difficult to get error free Computer Software and Systems. So it become necessary to validate the system which Avoids lots of downtime, Disruption, and Escalating Costs once these Computer Systems started using for Production Purpose. Also there should not be Any Deficiencies in the system during Regulatory Inspections.
Company’s needs to Satisfy Auditor that Computerized Systems installed are Fit for their Intended Purposes by considering the Nature of the Application, Specifications, Quality Assurance of the development Life-Cycle Activities, Qualification, Performance Validation, In-Use Controls, Accuracy, and Reliability in the context of relevant GxPs. Today, both the Industry and Regulators have a much better understanding of the ways and means to Develop and Validate computerized systems. Regulatory Inspections now have more to do with Risk-Based Assessments of what these systems are being used for in the context of broader GxP requirements Rather than Software and System Validation per se.
The GAMP-5 Guide has been significantly updated to Align with the Concepts and Terminology recent Regulatory and Industry Developments. These Regulatory and Industry Developments focus attention on “Patient Safety, Product Quality and Data Integrity”. This is a key driver for GAMP 5. 21 CFR Part 11 requires persons to “Employ procedures and controls designed to ensure the Authenticity,Integrity, and, when appropriate, the Confidentiality of Electronic Records, and to ensure that the Signer cannot Readily Repudiate the Signed Record as not Genuine.
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