INFOTEHNA’s Solutions

Today, the greatest challenge of Pharmaceutical industry is enormous quantity of documents, generated in hundreds of processes, which involve various groups of users in different organisational segments. Additionally, handling of these documents is subject to strict regulations throughout the GxP area.

To efficiently manage your documents in regulated environments, INFOTEHNA Group has developed all-in-one software suite that contains integrated solutions for:

• Research and development (R&DExpert)
• Quality assurance and quality control (QualityExpert)
• Regulatory affairs (SubmissionExpert)
• Pharmacovigilance (PhVExpert)

Benefits

• Easy survey and control of document status (draft/effective/archive)
• Each document is properly indexed, stored and protected, including versions
• Fast and user-friendly preparation and submission of dossiers in paper and/or electronic form (all dossier publishing formats including ANDA, NtA 98, CTD and eCTD)
• Effective post-submission management of dossiers (letters of deficiency, variations, new indications, etc.)
• Automatic audit trail reporting (no need for any XLS sheets or paper notebooks for tracking)
• Production of document change request
• Easier and time-saving project management and reporting
• Compliance with all regulatory requirements, including 21CFR11