Strategies for DFA Compliance
Business Process Management

The Right Approach for the Right Solution. How we are different.

Business Process Management for Quality Processes.

Ever wonder what it would be like to move completely away from the paper world?


Typically, we see a batch record process that requires multiple forms to be completed by multiple individuals across both operations and quality. At the end of the process those forms are then gathered up and filed away sometimes in an uncontrolled storage area.


All the information captured on those forms must then be transcribed into spreadsheets for further analysis which means huge potential for human error.


As it then comes time for the annual product review this data must once again be replicated by pulling the batch records again to analyze data in a manual process.

Here we have found that some forms might be missing with no idea where they are or if they were ever there in the first place. Fortunately for you a government agency has not come to your site to review any of these records. It is not panic time, yet, but where are the forms and what else might be missing?


Sound familiar? Let us show you a much more efficient and compliant approach…


Challenge:

As you look at potential Quality Management System software your goal now is to work towards: 

  1. 1
    eliminating forms,
  2. 2
    automating processes, and
  3. 3
    realizing all the benefits of a Quality 4.0 driven system.

Can you really automate all these forms? Better yet, are you looking at the right solution to streamline the processes, not just the forms? The good news is that we have a way to achieve those goals and provide a solid framework to manage not only your forms, but the entire process all while aligning with Quality 4.0.


To realize your goals, the future of Quality management must be embraced. It is paramount that your organization make the connection between quality excellence and the ability of the organization and individuals to thrive in disruption, using quality principles to enable such transformation and growth. You must understand the relationship between People, Process, and Technology.


People
We will help your quality professionals’ transition from the enforcers to the navigators. They will be able to successfully guide the organization through the digital disruption and towards operational excellence using the most advanced technology married with how best to optimize the process.


Process
Your processes will continue to evolve over time. The quality professionals must understand how best to optimize these processes and associated that are vital to not only the quality team, but the overall business operations. The quality organization is the vital link in the transformation process. They must be included at the strategic level for sustainability during digital transformation.


Technology
Technology is changing faster than at any other time and organizations platforms and the way you manage processes, systems, data, operations and governance, must keep pace. You must educate yourself on the new technologies and how they will transition you from the analyst role to the process automation and data manager role.

Solution:

Do not fear for the Azimuth’s expert team understands the process and how you must position your organization to transform in this digital world. We have the experience, knowledge, and technology to assist in this transition. The technology we provide meets and exceeds a wide range of capabilities, including:

  • Artificial Intelligence,
  • Big Data,
  • Blockchain,
  • Business Process Management (BPMN 2.0 Compliant),
  • Data Science.
  • Machine Learning,
  • And others ...

We can show you how to automate all your process, based on how you work, not how some vendor forces you work. At the end of our engagement, you will know how to automate your processes, such as:

  • CAPA,
  • Change Control,
  • Deviation,
  • Laboratory Investigations,
  • Nonconforming Product (NCP),
  • SCAR, and
  • any other process that requires some type of standardization.

Fortunately, we work with some of the leading BPM technology companies that provide the capabilities you need to achieve such a lofty goal. These platforms include:

  • Appian,
  • AuraQuantic,
  • SoftExpert,
  • ValGenesis.

Azimuth Compliance Consulting can provide your organization the guidance and training you need to reach your digital transformation goals.


First, you should decide which path to follow. iBPM technology is where your journey begins.


We will then show you how to achieve your goal of eliminating forms, automating processes, and working towards a paperless environment.

Your Options:

I am looking to purchase a new or replace an existing QMS solution to take advantage of iBPM technology
Augment your legacy QMS with an iBPM platform to automate process and bring together disparate systems