Are Your Investigations Timely? – Inquiring Minds (Auditors) Want to Know


It has been a while since my last blog entry given the busy year we’ve had here at Blue Mountain.  So, I decided that the best way to kick-start my blog entries was to focus on a topic that I most enjoy writing about.  That is, how technology can be applied to improve business practices and solve business problems.   Specifically, I chose to blog about the use of Subscription-Based reports (more on what these are later) to monitor the progress of investigations.  In the Blue Mountain RAM application, investigations can be automatically generated and tracked using records purposed to capture Non-Conformance or Out Of Tolerance investigative information.  In one of my earlier blog posts titled Off the Labeled Path, I described how this can be accomplished.   With this post, however, I plan to focus on applying SSRS Subscription technology to augment the processes built around this type of information.

The GMP Scenario : Timely Investigations of Non-Conformance

In the Life Sciences industry which is heavily regulated by the FDA, it is critical for companies to manage the risks associated with manufacturing and demonstrate control of their processes.  One way in which this is done is through Non-Conformance Reporting and Investigation (a.k.a. NCR).    An NCR Investigation is typically initiated as a result of an event that occurs which does not conform with pre-established limits, specifications or procedures.

A few examples include…

  •     Failed Calibration or Out of Tolerance
  •     Post Due Date Completion of Work
  •     Cancellation of Planned Work

A key reason why such investigations are important is that the non-conforming events have the potential to affect critical processes and/or products produced and ultimately the safety of the consumer.  In GMP environments, it is incumbent upon the manufacturer to not only investigate (and document) the impact of these types of events but to also do so in a timely manner.

Below are some examples of referenced in actual Form 483’s issued by the FDA :   

“…Another employee involved in the lyophilization process does not have documented training in the film’s Nonconforming Product Procedure or Out of Tolerance (OOT) Procedure. This employee is required to be trained in procedures instructing employees on how to handle equipment that is not working properly or performing out of specification.”

“… personnel knowingly utilized during the compounding of sterile preparations several balances that were out of calibration…Furthermore, site did not investigate any of these deviations to determine if there was any effect on the final product. In fact, your written procedures do not discuss initiating an investigation to determine whether product may have been impacted, nor discuss corrective actions for equipment that does not meet acceptable tolerance limits.”

The Technology : Subscription-Based Reports

So what is a subscription-based report?   A subscription-based report is one that is automatically delivered at a specific time or in response to an event.  Subscriptions provide an alternative to running a report on demand which requires you to actively select the report each time you run it.  Subscriptions can be used to schedule and automatically deliver the report via email or to file shares on your network.

The Blue Mountain RAM product utilizes Microsoft SQL Server Reporting Services, commonly referred to as SSRS.  SSRS is a server-based reporting platform that provides comprehensive reporting functionality including a complete set of tools for users to create, manage, and deliver reports including (you guessed it) the ability to define “subscription-based reports”. 

The Solution : Subscribing to a Report to Monitor Investigations

Within Blue Mountain RAM, users are given access to customizable workspaces that allow them to build and run queries to monitor the status of outstanding records such as NCRs.   While the application workspace is ultimately where the user needs to be in order to modify or sign for those records, it is also of value to be reminded of the status of outstanding records without logging into the application.    A subscription-based report is an excellent tool to meet this need.  Not only can it be delivered automatically on a periodic basis to ensure that you do not lose track of outstanding issues but the output can be customized to look at the information in more specific ways.

In Figure 1 & 2 below, I have illustrated some of the configuration options available for a report subscription as well as an example of how the output of a report might be customized to emphasize critical aspects of the information you are tracking such as age.  With this report example, the outstanding (Open) NCR records are grouped into color-coded aging buckets with the oldest receiving the emphasis.   Since the report is automatically delivered to your inbox, the risk of overlooking critical information requiring timely action can be greatly reduced using a subscription-based report.


Other Potential Applications

Some other applications for subscription-based reports might include…

  • Service Level Monitoring for User Request response times
  • Parts at their Reorder Point
  • Vendor Certifications Due
  • Etc.

In summary, the power of report subscription technology combined with the flexibility provided within the Blue Mountain RAM platform both offer real opportunities to streamline GMP business processes and manage compliance risks by acting on available information in a timely manner.   The various FDA citations in recent years are a strong indication that this is also important to the auditors.  To follow up to this post, I’d like to welcome you to post comments and/or contact me directly ( with questions or ideas on how subscription-based reports might be applied in applied to your existing or future implementation.

Figure #1 – Subscription Configuration


Figure #2 – NCR Monitor Report

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