While your Life Sciences company grows, regulatory requirements are becoming stricter than ever. When certificate generation that still requires manual intervention is no longer feasible, Tenthpin Intelligent Certificate Generation (T/ICG) enables businesses to turn what had been weak points in their quality processes into a significant competitive advantage.
What does a Product Quality Officer’s Day look like?
For most Product Quality Officers (PQO) in Life Sciences companies, the day usually starts with an overwhelming amount of batches to be approved and certificates to be created. Although ERP systems like SAP handle basic certificate generation, they often fall short on comprehensive compliance requirements, leaving gaps that require manual intervention to ensure full regulatory adherence. On top of that, the massive volume of various types of certificates means a simple error can trigger a domino effect.
As a PQO, there is pressure right at the start of your day. Each certificate you process represents a protection for patients. It is also the foundation of trust in the business you work for, whether it is Pharma, MedTech, Biotech, or other Life Sciences sectors.
A single mistake can delay shipments, preventing patients from getting the therapies they need. It can even have more serious consequences, such as unsafe products reaching patients. Either outcome puts the patient's health at risk. Feeling the weight of this huge responsibility on your shoulders, you get your hands on your work.
Today, a PQO’s biggest challenge isn’t creating certificates from scratch; it’s managing the fragmented systems that generate them. Despite automation, missing data fields frequently require manual entry, and incomplete information from source systems means PQOs must constantly fill in the gaps to complete certificates. A significant part of your workload stems from the laborious process of integrating and summarizing information from several of the enterprise systems, such as:
- Lab results, typically sourced from Laboratory Information Management Systems (LIMS)
- Customer data, retrieved through ERP systems like SAP
- Batch characteristics, obtained from Manufacturing Execution Systems (MES)
While some data may be automatically retrieved, this fragmented approach requires constant cross-referencing and complicated formatting adjustments. Generating a certificate is like assembling a complex puzzle with pieces from different boxes.
By mid-morning, you feel tiredness has started to set in. A large part of your day is going to be spent in the quest for data integrity, cross-referencing information between LIMS, SAP, and MES. You must ensure the certificates comply not just with in-house demands, but also with strict regulatory guidelines or specific customer requirements.
Near noon, you notice something is not right. A decimal point in a batch specification doesn't align with the lab results. Can it be a typo? A formatting error? Or is it an actual deviation? Remembering that a misaligned figure could invalidate an entire shipment, you stop to check the cause of the discrepancy. This is the daily reality of a PQO: fixing the gaps where automation ends and manual rework begins.
Lunch is often spent at the desk, shifting between spreadsheets and PDFs, chasing missing signatures or tracking down the source of data discrepancies. There’s little time for proactive quality improvements or strategic initiatives because your main focus is navigating the relentless paper and digital chase.
Around 2:00 PM, you learn that an audit is planned for next week. Since most records are dispersed among various systems, building a clean audit trail will be extremely stressful. When it comes to Quality Compliance, even a slight lapse can lead to a cascade of effects. The FDA doesn't miss data integrity gaps, and the financial cost of an error can be sobering.
As the workday comes to an end, you sigh and close your laptop, reflecting on all the manual workarounds and constant pressure. This is your daily reality, rooted in dispersed systems that not even the most competent professionals can outrun.
Intelligent automation for uncompromised quality
As a Product Quality Officer, you are familiar with the feeling of living on manual workarounds. Perhaps you even have an uncomfortable sense that your hard-won expertise is buried under all the administrative overload.
But technology for Life Sciences is evolving, and your day-to-day can look different, too. Nowadays, you no longer need to chase signatures and try to cobble together multiple records. Instead, all critical tasks can happen in the background, seamlessly, accurately, on time, and with automated routines and checks in place.
The introduction of T/ICG would be a game-changing turn in your work activities. Beyond automation, the solution brings intelligent process transformation by integrating with core enterprise systems like SAP S/4HANA and LIMS.
How does T/ICG work with Certificates of Analysis and Certificates of Conformity?
T/ICG is part of Tenthpin’s Intelligent Quality Suite, a cloud-native, AI-driven platform designed to modernize and simplify Quality Management in Life Sciences.
As a batch passes quality assurance (QA), T/ICG autonomously retrieves and formats all necessary data. It applies the appropriate country-specific layouts and submits the certificate for review, all in a few seconds. In the end, it delivers the final documents to the appropriate stakeholders in a quick and fully traceable way.
Rather than pursuing signatures or searching for fragmented information, PQOs can have a fully automated solution that ensures data integrity. This is the level of oversight a robust Quality Management Solution truly requires.
With T/ICG intelligently managing the most time-consuming and mundane tasks, your day-to-day can transform dramatically. Quality tasks become much faster and more intelligent, fostering a sense of confidence across your team. Quality professionals can instead focus their time and expertise on the strategic initiatives that will move the organization forward.
Strategic impact of T/ICG to reduce operational costs
- Accelerated batch release and time-to-patient: The automation and flexibility provided by T/ICG result in faster product availability, which is a critical factor in the competitive industry of Life Sciences.
- Improved compliance and risk mitigation: The adoption of T/ICG results in a significant reduction in overall certificate creation and faster closure times. This reduces the risk of compliance issues, potentially saving costs by avoiding penalties.
- Operational cost optimization: T/ICG brings considerable productivity improvements, as a significant portion of manual documentation work is cut down.
- Empowered quality professionals: By automating time-consuming, administrative work, T/ICG frees your quality team from dedicating a large part of their week to repetitive, low-value-added tasks. Highly skilled quality professionals can redirect their expertise toward more value-added activities, such as driving continuous improvement projects.
