"Good enough" in pharmaceutical manufacturing is never a viable standard. When patients rely on life-saving medications, the margin for error is non-existent. Yet, many manufacturers still struggle with the "quality by testing" trap—identifying defects only after a batch is completed, leading to costly Out-of-Specification (OOS) results, wasted materials, and regulatory risk.The shift toward Statistical Process Control (SPC) represents a paradigm shift from reactive fire-fighting to proactive process mastery. By leveraging real-time data through GS Premier, manufacturers can ensure that every tablet, vial, and medical device meets stringent safety standards before a single error occurs.
For any facility governed by the FDA or EMA, compliance with Good Manufacturing Practices (GMP) is the baseline. However, achieving sustained compliance requires more than just following Standard Operating Procedures (SOPs); it requires a deep understanding of process variability.
Statistical Process Control allows quality teams to distinguish between "common cause" variation (inherent to the process) and "special cause" variation (external factors like equipment drift). By identifying these shifts in real-time, GS Premier provides the "early warning system" necessary to maintain a state of control.
In the healthcare sector, software must be as trustworthy as a paper-and-ink signature. Under 21 CFR Part 11, the FDA requires electronic records to be traceable and secure. GS Premier is designed as a "Part 11-ready" environment, ensuring:
Hertzler’s Medical and Pharmaceutical solutions provide a validated cloud environment where data integrity is the top priority, simplifying the path to Annex 11 and FDA compliance.
One of the primary benefits of SPC is the drastic reduction in batch failures. Out-of-Specification (OOS) results are not just a quality failure; they are a financial disaster. An OOS investigation can halt production for days and cost tens of thousands of dollars in labor and lost yield.
By utilizing GS Premier’s real-time visualization, operators can see a process drifting toward a limit hours before it actually breaches it. This allows for mid-batch adjustments—calibrating a tablet press or adjusting a mixing temperature—to bring the process back into center, effectively eliminating the risk of a rejected batch.
In a modern, data-driven facility, "SPC supplies" aren't just pens and clipboards. They are the high-tech tools that capture the heartbeat of your production line.
In healthcare, microns matter. SPC supplies include digital calipers, precision scales, and pH meters. The challenge is often manual entry errors. GS Premier’s integration capabilities allow these "supplies" to feed data directly into the cloud via RS232 or wireless connections, removing human error from the equation.
The most critical "supply" today is the data environment itself. Unlike traditional software that requires massive IT overhead, GS Premier is a self-service, cloud-based platform. This allows manufacturers to:
The most valuable supply is Actionable Intelligence. GS Premier provides digital dashboards that display X-bar and R-charts, providing a window into the process that static reports cannot match. When a trend (such as six consecutive points rising) is detected, the system sends automated alerts to quality managers, ensuring that "Quality" is proactive, not reactive.
There is a common misconception that high-level quality control is an added expense. In reality, SPC is a cost-reduction strategy.
Ready to move beyond spreadsheets and eliminate your manufacturing quality blind spots? Talk to an expert at Hertzler Systems or request a demo of GS Premier to see how cloud-based SPC can transform your production floor into a competitive advantage.
In healthcare and industrial settings, SPC "supplies" encompass both hardware and software. Key hardware includes precision measurement devices like digital scales, pH meters, and automated vision systems. The essential software "supply" is a cloud platform like GS Premier, which centralizes this data. In regulated industries, validation documentation and 21 CFR Part 11 compliant audit trails are also considered critical quality supplies.
GS Premier improves pharma manufacturing by shifting the focus from detection to prevention. It uses statistical methods to monitor Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs). This leads to fewer batch rejections, reduced Out-of-Specification (OOS) incidents, and a more robust Continued Process Verification (CPV) program as required by the FDA.
The FDA expects manufacturers to demonstrate that their processes are in a "state of control." SPC provides the mathematical evidence for this control. Through control charts and capability analysis, manufacturers can prove to auditors that their processes are stable and predictable, which is a core requirement of Good Manufacturing Practices (GMP).
Yes, significantly. GS Premier reduces costs by identifying process inefficiencies and variability that lead to rework and scrap. By preventing even a single batch failure per year, the system often pays for itself many times over. It also reduces the labor costs associated with manual data entry and OOS investigations.
Out-of-Specification (OOS) occurs when a test result falls outside the legalized limits. Out-of-Trend (OOT) refers to a result that may still be within the spec limits but is inconsistent with previous data. GS Premier is uniquely powerful at identifying OOT results early, allowing manufacturers to intervene before the process reaches an OOS failure.
Implementation requires selecting a "Part 11-ready" software solution. You must ensure the software supports electronic signatures, maintains a secure audit trail, and limits system access to authorized individuals. Hertzler Systems provides the software and expertise to help pharmaceutical companies navigate this validation process using GS Premier.
Reviewed by Phil Mason, MBA (December 2025): Phil has been the VP of Business Development at Hertzler Systems Inc. since January 2010. Previously, Phil was an Adjunct Professor at Green Mountain College (until Jun 2018), Associate Professor at Goshen College, Executive Director Adult/Graduate Programs at Goshen College (Jul 2015-Dec 2016), Assistant Professor at Bethel College (from Aug 2011), Business Development at Digitec, Inc. (Oct 2008-Nov 2010), Regional VP at Mennonite Mutual Aid (Sep 2001-Feb 2008), and General Manager at Ikon Technology Services (from Jan 1999).
Links: LinkedIn Quality Magazine FinalScout
