Our document management specialists maintain the regulatory document repository for dossiers, labeling, variation and renewal files, correspondences, PSURs, and pharmacovigilance documents for all products. Our team has experience securely managing the document workflow, including managing the entire document lifecycle process and a wide range of business documents, including regulated environments.
ClinChoice DMS specialists drive implementation and provide training to ensure regulatory compliance.
- Ensure the system is 21 CFR Part 11 compliant
- Support with Installation and Operational Qualification documentation
- Provide required technical support for implementation
- Develop training schedules and content
- Provide required maintenance support
Our support activities include:
- Creation of electronic data mapping document
- Electronic data re-arrangement
- Paper scanning
- Paper scan data migration to document management systems
- Sourcing and review of data to be migrated
- Liaison with country affiliates for quality control of documents to be migrated
- Workshops for regulatory affiliates
- Response to queries from affiliates