D.A.T.A. is a 21 CFR Part 11 compliant application used to manage and exchange information in all industries. It is made of three distinct modules: a document management system, an audit module and a training module. DATA incorporates several customer-driven enhancements and innovations.
Document Management System Module:
This module is a complete, innovative and secure document management system with full text searching/indexing capabilities. Documents are tracked and stored in the system, encouraging collaboration, while disallowing un-audited access or changes to the documents. The system is used for all types of documents, such as SOPs, Change Controls, Investigation Reports, Temporary Deviations, Batch Records, Validation documents, Protocols, Reports etc.
D.A.T.A. will enable inter / intra-facility paperless communication, reviews, approvals, and release through a sophisticated system with e-mail notifications, multi-level security, and multiple user authorities.
Audit Management Module:
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 Module:
This module is used to manage the training/re-training schedules of personnel, and to 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; the results of the test are automatically calculated and stored in the database for later retrieval.