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Pharmaceutical manufacturing environments are dynamic, requiring frequent changes to processes, documents, equipment, methods, and materials. These changes whether driven by regulatory updates, audit observations, continuous improvement initiatives, or technology upgrades must be evaluated, approved, implemented, and documented in a compliant and traceable manner.
Manual or semi-automated change management often leads to:
Thus, a centralized, automated, and compliant change management system is essential.
of change request initiation, review, approval, and closure.
with auto-notifications and task tracking.
through electronic records, e-signatures, and full audit trails.
involving QA, RA, Production, QC, and other departments.
of change status and associated actions (e.g., document revisions, training, validations).
in change cycle time and mitigation of compliance risks.
QEdge Change Management stands out by combining deep domain understanding of pharma regulations with modern EQMS technology. Here’s how it gives you the edge:
QEdge Quality Management Software Suite
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6th Floor, Arista, 100 Feet Anand Nagar Rd, Jodhpur Village, Ahmedabad, Gujarat 380015
Phone : +91-79-66214899
Email: sarjen@sarjen.com