How we support Pharma
companies
Push-Button Reports for Pharma
Redica Systems helps you filter out the noise and focus on the most relevant insights to your team and business. One way we do that is with our enhanced reporting, which we call Embedded Analytics—helping your company understand salient insights more easily with interactive maps, graphs, and charts. These reports let you view trends over time rather than just a point in time, helping your teams make better-informed decisions. Here are some popular examples, but this list is not exhaustive. We are constantly adding more Embedded Analytics views.
FDA Investigator
Look into your FDA investigator before they show up. Discover their global inspection history, including industries visited, frequency of FDA Form 483 or Warning Letter issuances, and shifts in focus from a quality perspective over the years. This information empowers you and your team to prepare effectively and identify inspections most relevant to you. Use filters to narrow down specific Industries, Inspection Types, Scopes, and Regions to compare inspections.
PAI Inspection and Enforcement Trends
With the trends this report provides, you can look at companies like you to see what they went through during their pre-approval inspection and train your team with the data gathered.
483s
Stay updated on the latest FDA Form 483 documents you won’t find anywhere else—filter for Date, Industry, Scope, Country, and Region. Redica Systems has the largest database of FDA 483s outside of the FDA itself.
Site Risk Scores
Redica Systems assigns a relative risk score to every pharmaceutical supplier. This dashboard aggregates the Red Flag scores at the Site level and ranks the Sites from best to worst. It also shows how the Site score changed over time. With this knowledge, your company can make better supplier partner decisions that can have an enormous impact on your success.
483 Red Flags
Red Flags from FDA Form 483 observations attributed to your Site Groups. Filter by Date, Site Name, Location, FEI, Industry, and Scope.
Recent Events
Details of Recent Red Flags for your Site Groups. Filter by Date, Site Name, and Location.
Global Regulatory Intel Dashboard
See what is changing week over week with regulations and guidances across the world. Quickly view recent documents with a change in status for drafts and in force. Don’t miss anything that impacts you and your team. Filter out any R2G2S categories that don’t apply to you so you don’t have to sift through irrelevant updates.
Agency-Specific Regulatory Dashboard
This dashboard shows the latest signals and activity with a targeted approach focusing on just one agency, e.g., FDA, China, or EMA.
Latest Regulatory Signals Report
Another way to visualize the data for regulatory surveillance. In this report, you can sort through the latest signals in a table format to see what matters most—filter for Date, Industry, Scope, Source (Agency), and more.
Inspection Preparation with Redica Systems
Experience proactive inspection readiness in action, reduce compliance risk, and enhance your team’s efficiency. Access the largest database of inspection documents—including 483s, 483Rs, and EIRs—outside of the FDA itself. Paired with advanced analytics like trend reports and user-friendly labeling, you’ll be fully prepared for the next time an investigator is at your door.
Redica Systems Inspection Intelligence is particularly relevant for people who focus on:
- Internal Audits
- Quality Assurance
- Quality Processes
- GMP/GCP Compliance
Below are a few use cases for our inspection data.
Go from reactive to proactive with fact-based inspection preparation
- Investigator profiles
- Inspection outcomes mapped to quality system
- Inspection types
- Industry trends mapped to GxP quality system
- Peer benchmarks
- And more!
An 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 quickly see how to prepare for your inspector’s tendencies and hot-button items.
Ace your pre-approval inspection
If you’re taking a new drug to market and you’ve reached the Pre-Approval Inspection milestone, you’ve invested far too much 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.
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?”.
Improve your Internal Audit Training Program
Internal Audit leaders can inform their programs with the latest insights into agency inspection trends, quickly filtering by inspection type, inspection reason, scope, dates, inspection location, and more.
With our data, you can 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.
Vendor Quality with Redica Systems
Supplier Intelligence from Redica Systems helps your team identify and control risk with your critical GLP, GCP, GDP, and GMP vendors. A solid manufacturing agreement is necessary but not sufficient. Redica Systems helps your team ensure that you are getting notified of your suppliers’ enforcement actions from the FDA in a timely manner, and that you know the risk associated with each supplier.
Below are a few use cases for our Vendor/Supplier Quality data.
Get the facts on vendor/supplier risk
- Supplier scorecards with full inspection history
- Monitoring and alerts for inspections and enforcement
- Vendor benchmarking
- Supplier due diligence
- Review EIR and 483 responses
View a Site’s entire regulatory history
With over 330,000 unique Site Profiles across GLP, GCP, GDP, and GMP vendors, you will never be in the dark about your vendors’ regulatory history and their most up-to-date inspection information.
In one place, you can quickly vet potential vendors or monitor the folks you already have an agreement with. Saving your team time and the headache of collecting data on your own.
Create groups to monitor your entire vendor universe
Create multiple groups to monitor competitors, potential vendors, or current suppliers—ensuring you never miss an inspection or enforcement action issued. With the ability to see trend reports across your multiple groups you can view exactly where issues lie (ex. Production or Laboratory) helping you and you team determine how and when to conduct an internal audit.
Regulatory Surveillance with Redica Systems
Redica Systems’ Regulatory Intelligence provides comprehensive regulation and standards monitoring to put the “c” in cGXP and helps leaders get their arms around what’s new/changing in the global regulation landscape to facilitate informed decision-making.
Below are a few use cases for our Regulatory Intelligence Data.
Keep your arms around the world
Stay current with the latest regulatory updates impacting your specific areas of interest (ex., GMP, GLP, GCP, Human Drugs, etc.).
- Global GxP source coverage
- Enriched and searchable content
- Simple dashboard
- Integrated workflows
- Translations and change tracking
More than just FDA Data
We monitor over 200 Global Regulators, Harmonizing Organizations, Standards Bodies, and Trade Associations, so you don’t have to! With Redica Systems, you can customize your feed for the scope most relevant to your needs, enabling you and your team to focus on the parts of the business that are most important to you.
Customize your feed for what you need
Along with our sources, we have content categories and themes you can follow or remove from your feed. With pre-triaged themes get the key topics that are top-of-mind in the industry, such as Nitrosamines, Data Integrity, Cell & Gene Therapy, Cybersecurity, and more. Go beyond keyword-based searches and customize your experience using powerful labels that include Industry, Scope (e.g., GLP, GMP, GCP, GMP for IMP, etc.), and Source (e.g., EMA and U.S. FDA).
Get a Demo
We’ll can show you insights into any of your key suppliers, FDA investigators, inspection trends, and much more.