Document Management
Document Repository for all internal and external documents. Compliant with CFR 21 Part 11 and GMPs
CAPA (Corrective and Preventive Action)
Interactive form attachments permit you to fill out corrective/preventive actions
Deviations
Provides customers with the tools to effectively document, resolve and approve deviation records.
Complaint Management
Provides the ability to record, investigate and respond to complaints, in addition to monitoring trends.
Change Control
Change Control module provides comprehensive control and visibility over the entire life cycle of a document.
Learning Management Module (LMS)
The Learning Management Module (LMS) module is an ideal online training solution for any organization.
Features
- Document Repository for all internal and external documents
- Compliant with CFR 21 Part 11 and GMPs
- E-signatures
- Communication via e-mail (alerts / reminders)
- Secure documents allowing only authorized personnel to move, edit, archive
- Detailed audit trail includes:
• System-stamped date and time
• User who performs the activity
• Information of action performed
• Reason for changes
- Flexible roles / responsibilities that can be assigned based on customer needs
- Review and Approval workflow
- Cross-references to link related documents
- Task list allows users to see which tasks are assigned to them
- Assign time requirements for certain workflows and issue alerts / reminders to assure timely completion
- Searchable
- Revision history
- Option to stamp documents for printing
- Capability to control variety of document types:
• SOPs, policies, work instructions
• Forms
• Batch records
• Certificates of Analysis (C of As)
• Regulatory submissions
• Regulatory correspondence
• Deviations / Investigations - CAPA
• Documentation related to change control
• Validation documentation
• Manuals, instructions
• Employee training and qualification records
• Project documentation
• Investigation documents, photographs, etc.
• Audit reports and follow-ups
- Change control process
- Editable templates (default and / or user created)