Manage Documents/Audits/Training/CAPA
The Document, Audit and Training application is fully compliant to 21 CFR Part 11 regulations and is used to manage and exchange information. It provides a document management system, full audit trail and extensive personnel training functionalities. The DATA application consists of the following modules:
Document Management:
- Full text searching/indexing
- Documents are tracked and stored in the system, encouraging collaboration, while disallowing un-audited access or changes to the documents
- Used for all types of documents, such as SOPs, Change Control, Investigation Reports, Temporary Deviations, Batch Records, Validation documents, Protocols, Reports etc
Audit Management:
- Manages and records all activities associated with internal and external audits. Once an audit is registered in the system, users are notified by e-mail when completions, reviews and approvals are required or entered, when deadlines are impending, or when specified tasks are outstanding
Personnel Training Management:
- Used to manage the training/re-training schedules of personnel
- Create and manage tests to assist with, or determine retraining needs
- Users can take pre-registered tests over the company intranet or via the software interface
- Results of the test are automatically calculated and stored in the database for later retrieval