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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 development and validation of Clinfoware® System & VDataWare.
Vsoft's products - Clinfoware® System & VDataWare fulfill all regulatory compliance requirements as follows
To provide fully integrated e-clinical solution for worry-free clinical trial with more efficacy
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
Quality Assurance
Vsoft follows RAD (Rapid Application Development) methodology for development and validation of Clinfoware® System, which proposes that products can be developed faster and of higher quality by:
Attending workshops and focussing 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 re-use.Vsoft, highly competitive and knowledgeable QA team ensures that the process is followed correctly and all the documentations are in place. All documentations starting from 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 interval of time to check the overall quality of the company. We also validate Business Continuity Plan annually to test our adaptability for adverse effects.