Why do you need a Quality Management System?
It’s really quite simple.
- Customer Focus – You need a Quality Management System in order to provide your organization with a strategic direction and focus on customer expectations and compliance
- Compliance – You need a secure, safe and compliant place to store your Electronic Records in order to meet 21CFR Part11 Regulations and avoid findings, fines and/or Warning Letters including:
- Validated Environment – (21CFR Part11 11.10a) Validation of systems to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records.
- Audit Trails – (21CFR Oart11 11.10e) Use of secure, computer-generated, time-stamped audit trails to independently record the date and time of operator entries and actions that create, modify, or delete electronic records. Record changes shall not obscure previously recorded information. Such audit trail documentation shall be retained for a period at least as long as that required for the subject electronic records and shall be available for agency review and copying.’