What are the key features of a GMP Compliant Automated QMS?
Many life science manufacturing companies want to implement GMP compliant automated qms to streamline their processes. As a result, their quality management systems have become more efficient and leaner. Organizations with automated quality management systems save a lot of time. Now, their employees can focus on more value-added activities where there is a bigger impact. In today’s market organizations need to benefit more from automation. It helps to customize processes and workflows and integrating different applications for enhanced quality management. Automation helps to reduce working hours of factory workers on average per week.
Automation plays an important role in worker safety by displacing workers from the workplace, thus protecting them from hazardous factory environment. So there are some important features of automation that an organization should look in to before automating their quality systems
Flexibility
Very often companies look for the automated QMS which determines their process of quality management. But a much better choice would be opting the system which is flexible enough to integrate into the existing system. It should help your system to evolve into a much better compliance management process.
Customized workflows
- A flexible automated QMS system allows you to build your own customized workflows for a different type of processes and events.
- Allocating workflows for different customer complaints, document reviews and corrective action items between different teams.
- Assigning or distribution of work between different employees in the organization when key people are away from work.
- Scheduling timely escalations, notifications and alerts to notify supervisors about approaching deadlines and delays in action items.
System integration
Compliance management is more likely connected with different quality solutions and processes, integrated quality management will be very useful in streamlining the below-mentioned areas of Quality management.
- Document control.
- Audit management.
- Corrective action.
- Employee training.
- Complaint handling
- 21 CFR Part 11 electronic signatures.
- Audit trails
You should also able to integrate your QMS system with incident reporting system and vendor management system as well.
Risk-based approach
Even after Automating your Quality management system, you need key persons in the industry to make important decisions. You can standardize the process for more consistent results.
Integrate risk-based approach into the process
- A QMS solution should be able to drop a risk template into any application, which allows you to:
- Identify high-risk gaps where compliance requirements are not met and don’t have sufficient controls in place.
- Perform a risk-based verification process before closing the corrective action item To ensure action is truly effective.
- Categorize suppliers based on the level of risk which helps to measure their relative importance and quality performance in the supply chain.
Advanced reporting
Automation of GMP compliance should also include advanced reporting Capabilities which helps in data-driven decision making. With advanced reporting, a lot of time will be saved which we will usually spend on data collection.
Report templates:
You can set up templates for the reports you regularly use and it can be generated whenever you want with a single click.
Auto-generation:
You can use the auto-scheduling feature to generate reports on regular intervals on a specific set of metrics and distribute them among different teams.
Exception reporting:
Set alerts and notification guidelines for specific conditions or events when they did not meet the required conditions.
Automating GMP compliance is all about finding what is best for your business and your quality management system which enables you to perform the quality operations effectively.
Easy Access
very user-friendly, easy to use and made to aid hectic tasks and streamline quality control. access it from everywhere as long as you have a device with an Internet connection.
Effective Communication
A system which facilitates Real-time, productive dialogue between management, employees and third-party organizations in the supply chain can make quality management more efficient.
Transparency
It is pertinent that the QMS is centralized and organized in a way that maximizes its functions to multiple users across the organization Ensuring data transparency.