Life Sciences Inspection Preparation with Redica Systems

FDA-regulated life sciences companies are too often caught by surprise by inspections, resulting in 483s or worse, which have real business impact. This video shows how Redica Systems data can help you be in a constant state of inspection readiness. Go from reactive to proactive and from anecdotes to reliable data-driven decision-making.

Redica Systems Inspection Intelligence

is particularly relevant for people who focus on:

Inspection Readiness
Internal Audits
Quality Assurance
Quality Process
GMP Compliance
inspection type

Document types available for analytics:

483s
483Rs
EIRs
Warning Letters
FDA Investigator profiles
Site profiles
And much more

Use cases:

Prepare for: 
Pre-approval inspections (PAIs)
For-cause inspections
Routine inspections on all GxPs
Internal audit planning
Learn how the industry is trending:
FDA inspection trends, including what is being cited
How sites and/or organizations like yours are faring

Investigator On Their Way?

We’ve heard an industry saying that we really appreciate: “You don’t get inspection ready, you have to be inspection ready.”

Too many life sciences companies still panic a bit when they know that an agency investigator is coming for an inspection. Even more so knowing that a particular site is subject to unannounced inspections.

What if you could simply look up the profile of the investigator assigned to the inspection and clearly see what they tend to cite and what their 483 issuance rate was?

With more than 4,500 distinct FDA Investigator Profiles containing data from proprietary research and quality-system classification, you’ll easily see how to prepare for your inspector’s tendencies and hot-button items.

investigator on their way

Ace Your Pre-Approval Inspection

If you’re taking a new drug or medical device to market and you’ve reached the Pre-Approval Inspection milestone, you’ve got far too much invested at this point to risk a poor PAI performance.

Organizations should consider a mock PAI 6 – 12 months before the real inspection to address any issues – use Redica Systems to prepare during your mock PAI by looking up data on the specific investigator, recent FDA PAI trends, and more

Read our post titled “PAIs and 483 Issuance Risk: The Trends Are Not What They Seem

Establish a PAI readiness team

Quality Auditors

Set up Audit personnel and activities

Front Room for FDA and Organization representatives
Back Room aka “War Room”
Key Personnel
Document Review
SME Coaching

Must be in compliance with the FDA Chapter 46 – Pre-Approval Inspections

FDA Investigator will inform the Organization when they will come to inspect

If you’ve already aced your PAI, it’s not time to rest. Read our blog post titled “Why am I Being Inspected Again So Soon After a Pre-Approval Inspection?”.

ace your preaproval inspection

Improve Your Audit Training Program

Internal Audit leaders can inform their programs with the latest insights into agency inspection trends, easily filtering by inspection type, inspection reason, scope, dates, inspection location, and much more.

Base your audits and inspection planning activity on the most comprehensive and up-to-date inspection and enforcement trends and how you benchmark to the industry.

Compared to the FDA Data Dashboard

Too many life sciences companies rely heavily on the FDA Data Dashboard for their inspection preparation needs. While the FDA sets the bar for health agency transparency, the various FDA online databases have some limitations. Read our post titled “How Redica Systems Goes Further than the FDA Data Dashboard”. 

Common problems you may be facing

Limited or outdated information on inspection trends

Lack of benchmarking data on how competitors are doing with compliance

No public info on specific FDA investigators and their citation patterns

Lack of ability to segment data by important labels like Scope, Industry, etc.

Data from agency websites is limited

Overreliance on anecdotes vs. hard data

Manual processes slowing you down

Solutions delivered by Redica Systems

Full trending capability across the most robust quality and regulatory intelligence dataset in the world

Ability to look up compliance data on any competitor or supplier

Detailed profiles on nearly every FDA investigator, with full histories and citation patterns

Automatically labeled data so that you can run detailed custom reports

More documents and data than any other quality and regulatory intelligence platform or agency

Always be prepared with current, quantitative evidence

Automate away most of your menial data hunting and processing tasks