Regulatory Affairs
Regulation & Compliance
Quality is the most important aspect of a product. Vsoft has given utmost importance to quality by following all the processes required in the development and validation of Clinfoware®. Vsoft’s eClinical Solution – Clinfoware® fulfill all regulatory compliance requirements as follows:
- 21 CFR Part 11 Electronic Record; Electronic Signatures
- Computer Systems Used in Clinical Investigations
- OME standards
- Standards and guidelines provided by CDISC - CDASH, SDTM, ADaM, HL7 & ICH
- 21 CFR Part 11 - Scope and Application
- General Principles of Software Validation
- HIPAA compliant
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Quality Assurance
Vsoft follows RAD (Rapid Application Development) methodology for development and validation of Clinfoware®, which proposes that products can be developed faster and of higher quality by:
- Attending workshops and focusing on groups to gather requirements
- Following a schedule that defers design improvements to the next product version
- Keeping review meetings, walkthrough, and inspection
- Prototyping and user testing of designs
- Using reusable software components
RAD usually embraces object-oriented programming methodology, which inherently fosters software reuse. Vsoft’s highly competitive and knowledgeable QA team ensures that the process is followed correctly and all the documentations are in place. All documentations starting from the Validation Strategy Document to Validation Summary Report is drafted for each project (for clients).
Processes like requirements gathering, system design, implementation, unit and integration testing; IQ/OQ/PQ and User Acceptance Testing are performed according to a variety of documents including project plans. Unless the documentation/plans for the next stage are ready and approved, no activities pertaining to the next stage will be performed, thereby ensuring that the process flow doesn’t get tangled. After the targets of all the stages are satisfactorily achieved, the system is released for production to the client.
All the SOPs required for the successful implementation of the product and smooth functioning of the company are in place and followed all the time. There is a periodic review and revision of the SOPs. The Quality Assurance team performs self-audits at regular intervals of time to check the overall quality of the company. We also validate the Business Continuity Plan annually to test our adaptability for adverse effects.