Integrated Management Systems for Lifesciences Industries

Integrated management systems with the Integration of different quality management systems can increase efficiency, accuracy and effectiveness. It also helps to reduce costs due to unnecessary delays. It is essential for any organisation to increase its performance for continuous improvement and maintains their employee and customer satisfaction.

Integrated systems let your management systems work together with each other towards a single goal. It enhances the performance of your entire organisation and makes it more efficient and effective. An integrated workflow provides a clear and transparent image of your entire organisation, how they impact each other and the risks associated with each other. New systems can be adopted very easily in future with this integrated approach.

Quality and compliance solutions must evolve coping up with changes in the life sciences market. It is very important to collaborate, coordinate and interact across different areas of the organisation to uncover process gaps within the organisation and increase visibility. A good Automated quality management system will help to assess risk and define clear SOPs while keeping up with regulations.

Integrate QMS data with other applications and systems will help to eliminate silos and improve product quality, safety and processes. We cannot manage daily processes effectively by using the manual process. Automation will help to track data without wasting a lot of time and avoid missing due dates.

Advantages of integrating qms with other quality modules

Integration of QMS with other quality management tools will help you to understand the data which is useful for modelling, forecasting, and data visualisation. This helps to create a safe and controlled product.

Integrating risk management, CAPA, and audit management will result in the early production of the product into the market with minimum risk involved. Optimizing Vendor management will help to manage the complex structure of suppliers or contractors.

This will help an organisation to stay ahead and deliver the right products to the market.

Collecting the information from different sources helps to analyse and compound more data which helps to bring the product to market faster decreasing the level of disconnect between post-market feedback and product design.

  1. Document Control

Validation of quality systems is an important aspect of any organisation. Auditors will check all the documented information for validating the system. Document control involves the creation of transparent documents/reports.

Every step in the system such as planning, specifications, test planning, testing and review should be clearly documented.

All the documents regarding different processes and steps are combined to form a single report by document control to make it audit-ready. It ensures all the documents are up to date and has all the details of the changes made. It enables the automation of document routing from review to approval through distribution.

Integration of Document control with other quality modules makes the changes made any stage of the process reflect automatically in the office files and thus maintaining consistency for all users in real-time.

It offers companies with the complete solution of document control from change request to approval to publishing and training on all documents.

Risk Management

Risk Management Concept Diagram Illustration

Due to the increase in market shares in the Lifesciences industry, there is a need to bring products faster to the market than the competitors as well as balancing risk to the consumers. An effective way of managing risk is to take care of that in the design phase itself. Integration of the QMS system with risk management systems will help to track and manage risks throughout the research and development phase. It is also useful in identifying compliance gaps(regulatory, product quality, process, etc.,) while managing risks. They can be eliminated permanently if we identify the problems stem from where they are occurring.

Corrective Action

Corrective actions can identify and break the risky workflows and introduce change.

Corrective actions should mitigate risks and use closed-loop action items for efficient resolution. They are usually one time actions and are effective and efficient when performed systematically. If this corrective action plan is set, users can save a lot of time and focus on other important issues.

Corrective action steps involve root cause investigation, action plan creation, resolving the issue and verifying the effectiveness of corrective action. Using these series of steps in QMS can eliminate the repeated occurrence of the same issue which helps in overall improvement.

Supplier Management

Suppliers play a vital role in the creation of a quality product. Integrating supplier management with QMS is very important for efficient product development.

It allows users to identify the location of the product and track the movement of products. This helps to evaluate the cost of the problem and allows users to understand and manage the supply chain risk which can lead to recall. Supplier management will be there throughout the design and implementation of the product.

Supplier management involves

  • Assign ratings to the suppliers to benchmark the quality standards, introducing risk assessment to identify the probable source of future problems.
  • corrective actions are assigned to the suppliers for the effective resolution of issues by responsibility on suppliers.
  • Tracking the sources of problems from outside the company and directing them to other quality modules such as customer complaints and non-conformities.

Audit Readiness

Keeping all the audits ready and updated at all times will enable the organisations to provide internal and external data to the auditor within a moment. Audit management with traceability of events allow users to verify quality issues regarding any adverse event, and provide a detailed report of root cause and the corrective action implemented, and also their effectiveness.

Audit readiness will offer users with automatic scheduling, quality and safety reports, audit distribution, standard templates, and integration with other tools which gives the opportunity for continuous improvement.

Benefits of Integrated Management Systems

Improving Performance

Due to the increased collaboration of different quality systems, there will be a decrease in the non-conformities during the manufacturing process. Therefore there will be a positive outcome such as quality improvements, risk, safety and productivity. 

Eliminating Redundancies

Using multiple management systems allow us to find the most common or single management system components such as objectives, processes, resources, and policies. It means you may be able to implement a single procedure for training, internal audits, management reviews, and document control. This will save the organisation a lot of valuable time.

Accountability

When you set clear objectives and define processes and resources by integrating different management systems, you will have an improvement in accountability as well.

Establishing Consistency

When you have an integrated management system, the system will become less complex and easy to handle and understand. This, in turn, creates consistency in the process which will improve focus on achieving the important objectives of the organisation.

Reducing Bureaucracy

An organisation having multiple management standards can become very complex if management systems are not integrated. When management systems are integrated they can follow a systematic process which can reduce bureaucracy. Changes made can be easily accommodated in the process. Establishing process owners can be beneficial for an effective approach to overcoming the barriers to decision making and deployment.;  

Cost Reduction

Audits and assessments can be done in less time for integrated management systems utilizing minimum processes and resources. This will decrease a lot of interrupted time thereby reducing the costs.

Optimize Processes and Resources

Integrated systems create smooth and effective workflows which optimizes resources and processes. This will allow organisations to focus more on process implementation and value-added activities.

Reducing Maintenance

Regulatory organisations need to perform compliance checks regularly to maintain standard requirements. Integrated management systems maintain the requirements concurrently and streamlining the processes to focus on improvements avoiding unnecessary maintenance activities.

Facilitating Decision Making

Reduction in the redundancy and consistent process workflow in an organisation will give a complete view of functional needs and performance. This will allow organisations to analyse different functions which helps in better decision making by improved communication.

Conclusion

Automation of QMS with other quality management tools is extremely beneficial for companies to adhere to regulatory agencies. It allows users to focus more on company goals with updated processes, test procedures and necessary equipment for maintenance and risk control.

See how you can manage, optimize and automate your business processes today with AmpleLogic Pharmaceutical Quality Management System (QMS) and get a demo from one of our process experts or email us at info@amplelogic.com

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