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?
Upon understanding the importance of a Quality Management System in pharmaceutical industry, manufacturers implement advanced Pharma QMS system such as QualityMaster in their business. Equipped with all the essential functionalities, QMS in pharma allows manufacturers to seamlessly and effortlessly maintain the desired quality & safety standards of their products, processes & services.
QualityMaster, a best-in-class QMS system for pharmaceutical manufacturers to cultivate a culture by developing a risk-based CAPA process, managing non-compliance through QMS documentation, ensuring employee adherence to processes, ticking off audit checklists etc.
Pharma QMS provides the skills that organizations need to sustain quality across the product life cycle, from brand-new medicine research to post-market safety monitoring.
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
Effectively manage diverse pharmaceutical SOPs, including patient safety, medicine complications, machine maintenance, training, risk response, and much more….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
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
Effectively manage diverse pharmaceutical SOPs, including patient safety, medicine complications, machine maintenance, training, risk response, and much more….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
Benefits of Quality Management System in Pharmaceutical Industry
- Enhanced Business Processes: Tailored interfaces optimize workflow efficiency.
- Compliance with Standards: Ensures adherence to industry regulations and builds trust.
- Improved Control: Real-time alerts enhance control and enable swift responses.
- Customer Complaint System: QMS for pharma provides a structured approach to resolving issues and boosting satisfaction.
- Savings on Rework: Early issue identification reduces rework, saving time and resources.
- Customer Growth and Retention: Consistent quality attracts new customers and retains existing ones.
- Competitive Advantage: Demonstrates commitment to quality, providing a market edge.
- Improved Decision-Making: Data-driven insights facilitate informed decision-making.
- Employee Engagement: Involves employees in quality processes, fostering a positive work culture.
