Most pharmaceutical companies adopt a paper-based or partially electronic method to manage the quality of operational processes, organizational priorities, and compliance with rules. With the FDA and other bodies becoming increasingly stringent with compliance rules and policies, it becomes necessary for pharmaceutical companies- small, medium, or large-scale, to have a systematic approach to quality management. And the paper-based system, with its share of inefficiencies, chances for human error, and time consumption become obsolete in an evolving work atmosphere with complex supply chains, mergers and acquisitions, and tightening regulations. The need for an automated quality management system arises to speed up and connect all interrelated processes such as purchase, training, audits, deviation management, customer complaints, CAPA, etc.
FDA , the most prominent governing body for the pharmaceutical industry has been encouraging drug manufacturers to adopt technological innovations to lower production costs, increase the availability of more affordable medicines and thereby strengthen public health.
For pharmaceutical companies with no accurate workflows, a QMS solution can help to find out what is missing. A coherent QMS solution maps the entire workflow, processes, and people. It is built around them to bring about the difference.
Features that make the difference:
- DOCUMENT MANAGEMENT
It helps to assign, categorize, and organize documents across departments.
- TRAINING MANAGEMENT
Pharma is a sector that emphasizes on the training and certification of its staff to ensure a competent and compliant workforce.
- AUDIT MANAGEMENT
This helps to manage internal, supplier, and regulatory audits.
- SUPPLIER QUALITY MANAGEMENT
Identify and focus on premium suppliers.
- CHANGE CONTROL MANAGEMENT
As pharma is an ever-changing sector with new employees, new departments, and new regulatory rules being implemented quite often, a QMS solution should be able to manage the rapid changes and implement these changes into its seamless functioning. It should also be able to capture and analyze internal and supplier deviations.
- COMPLAINT MANAGEMENT
Streamlining of complaints and follow up are accomplished.
- OUT-OF-SPECIFICATION AND OUT-OF-TRENDS MANAGEMENT
Times may arise when there is a demand for out-of-specification and out-of-trends lab investigations. The system should ensure accurate results for such procedures.
- CAPA MANAGEMENT
The need to implement a risk-based corrective and preventive action process is high in a pharmaceutical setup to ensure regulatory compliance at all times.
But most small to medium-sized pharmaceutical companies may find it overwhelming to transit from a paper-based system they have been using for years to an automated system . The need to have a technically-strong team and the need to train all others to adapt to the new system might pull them back from the magic of what an automated QMS solution could do to their organization.
But, we, at Origami, believe in the power of simple solutions. Our cloud-based QMS solutions do not require technical expertise. They are simple drag-and-drop solutions with absolutely no coding. A lot is being developed by our existing clients in the pharmaceutical industry with no technical background. The system that comes on a low budget and runs in no time has been accepted with open arms in an otherwise complex work atmosphere.
Origami gives you integrated quality management capabilities to achieve your organizational goals, ensures that your team is adequately trained to follow procedures, supports data integrity, keeps suppliers under control, and helps to maintain overall compliance. With a structured approach to quality metrics and reporting, investigation of out-of-specification lab results, and the development of a risk-based CAPA process, Origami is all you need.
If you wish to change your existing quality management system or haven’t had one yet, Origami is here.