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TI’s 21 CFR Part 11 compliant eClinical platform provides assurances for audit trail functionality, for example eTMF audit trails, electronic signatures, security and data integrity, record retention, etc.
TI’s QMS complies with the ISO 9001:2015 international standard and is audited in accordance to enhance customer satisfaction.
All data centers comply with this standard for reporting on controls at service organizations.
Audited on rigorous quality standards for businesses – staffing, training, production, information management, and quality control measures.
TI’s policies and procedures are designed to comply with this standard and employees are required to pass introductory training.
Our computerized systems are GAMP 5 compliant and are evaluated based on the framework’s risk-based approach.
Quality assurance teams can manage standard operating procedures, policies, and any other documents from approved templates as required by the quality manual. Author, edit, approve, and manage quality documents.
Simplify quality knowledge management by connecting quality document processes to your training management.
Approve with eSignature
Share Approved Document to Training Management
Document Becomes Effective
Draft from Template, Edit, and Collaborate on Document