Quality Management System for Pharmaceutical Industry
What are the Major Quality Challenges in Pharmaceutical Industry?
Superior quality & customer satisfaction are the most important virtues for a pharmaceutical product. Customers depend on medicines for better quality of life and therefore, they expect high-quality drug compositions that are safe & effective, free from any contaminations or defects.
Quality is the only factor that gives patients the confidence to trust the next dose of their medicine. It simply means that quality issues are directly proportional to consumer distrust. Hence, any failure to meet the quality, efficacy & safety standards of the medicine can cost pharmaceutical manufacturers in the form of recalls, losses and damaged brand reputation.
This is the predominant reason for manufacturers to exercise the strongest measures of QMS software for pharmaceutical.
Manufacturers proactively try their best to avoid and effectively handle quality issues caused by non-compliance, process modifications, human errors and other such reasons.
How Does QMS in Pharma Industry help Address These Challenges?
Features of QMS Software for Pharmaceutical Industry
Efficiently handle pharmaceutical non-conformance (NC) issues like contamination, quality deviations, packaging defects, expiry dates, and compliance breaches. Perform root cause analysis and apply corrective actions to prevent recurrence….Read More
Manage, track, and resolve complaints like side effects, poor packaging, expiry dates, etc. of drugs, coming from various sources, ensuring customer satisfaction….Read More
Automate training activities, and create training schedules to make employees learn about GMP, compliance, safety, procedures& workflows, product-specific knowledge, hygiene, medicine ethics, and continuous improvement. Maintain accurate training documentation, conduct assessments, and evaluate training results….Read More
Establish a proper workflow for documenting changes, and automate, evaluate, review, and manage every step of the change control process….Read More
Store, create, track, retrieve & manage organizational documents such as drug safety protocols, SOPs, chemical specs, medicine quality records, and regulatory documents. Also, work collaboratively on the same document version, boosting teamwork….Read More
Manage various risks and their impact related to product quality and patient safety, and drive continuous process improvement through risk control and mitigation.
Store all your important documents in one place for easy access during internal or external audits, ensuring compliance with ever-changing pharma industry standards and rules. Also, conduct timely audits such as internal, regulatory, drug quality audits, etc….Read More