SOP Compliance Management for FDA Regulated Companies
Regulated companies establish policies and procedures (SOP) to communicate standards of performance, to establish quality and mitigate the risk of business process failure.
Effective SOP management optimizes organizational performance resulting in improved customer satisfaction, product quality, safety, and compliance with GMP standards and regulatory agencies.
What is needed for powerful SOP implementation:
- Efficient creation and maintenance of SOP documents
- Auto generation & synchronization of training content
- Consistent Support materials for use –Post training
- Continuous improvement of SOP documents
- Verification for SOP compliance
What is needed: A Support System for SOP Compliance Life Cycle Management
ExpressTrain developed by PRINCETON CENTER works with your existing document management software to support regulatory compliance, adds the automated creation of a consistent set of materials to the front end of quality management software, and enhances the efficient life cycle management of standard operating procedures used for ISO, regulatory & corporate policy compliance.
- Reduce the time between SOP acceptance & effective date of implementation
- Significantly reduce the cost to generate SOP & policy training content
- Reduce the time & cost of developing & maintaining SOPs
- Template structures for SOP development
- Works with your collaboration & workflow software for review & approval of SOP content
- Auto generate training material from approved SOP
- Efficient maintenance of training & Support content
- Automated Integration of SOP & related training, reference and verification content with your document, knowledge, & learning management software for compliance
Credit: Ideas from this piece were drawn from a piece written by Cary Baskin from Tools for Automation.