Strategies for DFA Compliance
Data Integrity


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

Data Integrity and Computer Software Assurance (CSA)

Major changes at the FDA have occurred over the past few years in the areas of GMPs and computer validation.

The FDA has come out with guidance documents related to data integrity and computer software assurance (CSA).


The focused is in three key risk areas:

  1. 1
    Patient safety,
  2. 2
    Product quality,
  3. 3
    Data integrity.

Data integrity inspections have focused on the document control departments. Many QMS systems do not meet current requirements.

Does your QMS solution address these areas? Our solution does.


Challenge:

  • Do I really have an issue with risk related to data integrity?
  • What has the FDA been focusing on recent investigations as it relates to patient safety, product quality and data integrity?
  • What should be included in my computer software assurance policy?
  • What improvements must I make in GMP facility to reduce the likelihood of receiving a 483 for data integrity?

Solution:

We provide the following starting points:

  • Solutions that comply with data integrity requirements;
  • Documentation required to ensure and quick and smooth validation effort;
  • Reduce effort in implementation and validation;
  • Continued support after implementation by the individuals who implemented the software not a help desk person who was not involved.

Azimuth Compliance Consulting can show you ways to reduce your validation effort while assessing risk based on patient safety, product quality, and data integrity. First, you should decide which path to follow. 

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
I am looking to purchase a single end-to-end validation solution that provides consistency, control, and transparency across my organization
I need help with my computer software assurance projects and am searching for an organization that understands my concerns and regulatory needs