INISCIENT Analyst fully integrates the requirements of general and domain-specific normative standards. The technology has proven its effectiveness in numerous projects with companies that must meet GMP requirements. The implementation results have been reviewed and accepted during formal inspections by Competent Bodies.
Its integrated and automated approach substantially reduces resource requirements during inspections or audits. Handwritten or typed organizational documents to comply with regulatory standards are automatically analyzed by INISCIENT. Each document is evaluated both individually and jointly for compliance with the designated standards of the current audit.
As the auditee, INISCIENT provides you with a precise list of requirements that your organizational documentation does not yet meet, giving you the opportunity to correct your weaknesses before the actual audit.
As the auditor, INISCIENT points you towards the unmet requirements, so you know in which direction you may conduct the audit.
A PDF report meeting traceability requirements can be edited, presenting
relevant information and results compiled by INISCIENT. All calculation results and reports are stored in a private and secure storage area on Microsoft Azure for safe and effortless follow-up of your organization’s progress.