In the pharmaceutical industry, the quality and traceability of reports determine regulatory acceptance, audit security, and ultimately market access. Traditional manual reporting is time-consuming, error-prone, and difficult to validate. A single error can have far-reaching consequences, from costly rework to regulatory action. StatSoft has a solution for this.
Offering pharmaceutical products in the US or European markets, requires the producing companies to adhere to GMP (Good Manufacturing Practices) standards. This includes a continuous monitoring of the production and product quality levels. The findings are collected in reports (e.g. CPV, APR, APQR) that are filed and provided to the regulatory authorities like FDA and EMA.
The monitoring of the production and quality is accomplished via statistical methodology (like SPC). The results of these methods (diagrams, KPIs, tabular data) are transferred to reports. This is a reoccurring, laborious task that requires expert personnel.
The monitoring processes - according to 21 CFR Part 11 – must be reasonably robust and have mechanisms to prevent manipulation. Only authorized personnel should be able to make changes to the process and interruptions must be avoided.
Organizations face many additional challenges:
- Disparate data sources and low data quality
- Many reports must be created, a template-based solution is needed
- Reports should be distributed to the stakeholders automatically
- Transparent and reproducible creation of reports
- Results need to be available in interactive dashboards to enable root cause analysis
Our Solution
StatSoft supplies customers in the pharmaceutical industry (and life sciences) with tools and services to enable a continuous and automated monitoring of production and product quality.
This includes a mature and established analytical platform (Statistica), that is enhanced with StatSoft-developed components and can extended with visual data science dashboarding (Spotfire).
These building-blocks form a powerful analytical platform where the customers stay in control. Customers can easily use it and can harness it’s capabilities to tackle many other analytical use cases as well.
StatSoft has a long-running experience with customers in this industry and knows how to solve industry-needs in the platform. This experience and the pre-built nature of the components guarantee a quick go-live, a tailored setup and reliable operation.
How To Approach A Validated Reporting Project
As every customer is unique, StatSoft supports them along the way as a fair partner:
- Assessment and selection of software
- Architecture of the system
- Installation and setup of software components
- Training of users regarding usage and maintenance
- Customization
- Documentation relevant for the validation of the platform
The maintenance of the system can be supported by StatSoft or stay fully in control of the customer. Expansions to the system can be done by the customer or with StatSoft’s help.
Benefits for Customers
StatSoft’s customers for validated reporting are satisfied customers, because challenges are overcome quickly with joint forces.
Some customers have told us why they have an efficiency boost from automated validated reporting:
- >50% reduction in manual effort in report creation
- Quick commissioning thanks to proven modules and standard processes
- Audit- and GMP-compliant reports for maximum compliance and less stress
Gains in efficiency in these departments through automation can be very beneficial to the organization as expert personnel can be assigned to much more valuable activities in R&D or for root cause analysis. In addition to these benefits, automation can help to reduce the likelihood of errors in the monitoring processes and corresponding reporting processes.
Interested in validated reporting? I am here to help!
Miron Schlömer
Whether it’s implementing automated reporting, optimizing production monitoring, or ensuring GMP compliance, the StatSoft team is your trusted partner. Let’s work together to boost efficiency and future-proof your processes!
