Strategies for DFA Compliance
Quality assurance

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

Quality Process Management For Life Science and manufacturing Companies

Let us talk through a typical manual, paper-based disparate quality management system. We all know the GMP requirements and most likely the ISO 9001:2015 structure. As concern for the upcoming FDA 2 year inspection grows, and as you look at the gaps in your Document, Change, Training, CAPA, Complaint Handling and Annual Product Review programs there is a gnawing feeling that it’s not going to be enough. This scenario plays out across the globe with both big and small companies. What is the goal? Compliance.


How do we get there? Let us explore further.

Challenge:

One of the growing needs for companies in the Life Science space is how best to manage documentation and practices based on the multitude of SKUs, sites, internal functions as well as across the matrix of your Tier 1, 2 suppliers. Without some type of streamlined automation, it becomes almost impossible to hire enough resources to oversee the 21 CFR 211, 600, 820, 1271 or ISO 9001 or 13485 quality regulation/standard requirements. And as we all know, it is all about data control, access, and security management.


Complete, consistent, and accurate data should be: 

  • Attributable,
  • Legible,
  • Contemporaneously recorded,
  • Original or a true copy,
  • Accurate,
  • Protected,
  • Made visible for reporting, and
  • Managed very carefully.

Sure, this can be done with a manual paper-based system, but this is not scalable, and prone to errors and mismanagement. Data integrity is critical throughout the CGMP data life cycle, including in the creation, modification, processing, maintenance, archival, retrieval, transmission, and disposition of data after the record’s retention period ends.


The challenge is how best to understand your program, assess the gaps, and pick a software solution that can expand beyond the quality organization and ensure the risk related to patient safety, product quality, and data integrity is addressed. It can be used by all, not just part of your operation/quality program, hosted in a cloud based, standardized, and easy to use application.

Solution:

With that, the Azimuth team is standing by to bring expertise to your software requirements, selection, implementation, and the all-important validation efforts. Of course, these are some functions your team can perform, but wouldn’t it be preferable to work with a group that has done turnkey solution management for several years across many types of companies?
We are providers of quality & BPM platforms that can bring:

  • efficiency,
  • cost reduction,
  • process control,
  • data integrity, and
  • a sense of comfort.

Comfort comes from knowing that as agencies and customers continue to audit to GMP and ISO standards you have the toolset necessary to show and maintain compliance.


What are you waiting for? Isn’t it time to make that decision and start working toward the journey of the state of quality process control, data visibility and personal accountability required by the regulatory bodies?

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.

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