How Digitisation Can Optimise Your Stability Sample Management Process
Stability programmes are rarely short of compliance attention. Regulators expect them to be robust, and most quality teams already know where the risks sit.
But there is another question that gets asked less often: how much time, space and effort does the process consume simply to stay compliant?
In our previous article, we looked at how digital tools can reduce risk and strengthen inspection readiness. Here, we turn to the operational side of the process.
Once a site moves away from paper logbooks, spreadsheets and fragmented manual tracking, where does the stability sample management process actually improve?
From Reactive to Planned
In a manual process, the pull schedule is often something people check rather than something that actively supports planning.
The difficulty becomes obvious when several pull points across multiple studies fall due at the same time. Suddenly the laboratory has to find the people, time and equipment to deal with them, often alongside other priorities.
A digital calendar changes that.
When every pull point across every study is visible in a daily, weekly or monthly view, the schedule becomes a genuine planning tool. Teams can see busy periods well in advance and allocate resources around the pull schedule rather than reacting at short notice.
That can mean a steadier workload, fewer last-minute reshuffles and less risk of an important pull being affected by competing priorities.
For sites managing a growing number of studies, this kind of visibility can make a significant difference to day-to-day stability study sample tracking.
Making Better Use of Your Storage Capacity
Stability chambers are expensive to buy, qualify and maintain, and the available space within them is finite.
Yet at many sites, understanding exactly what is stored where and how much capacity remains can still depend on a spreadsheet, logbook or a combination of the two.
The difficulty is that these records are only as current as their last update.
A digital stability sample management system gives teams a much clearer view of storage usage and available capacity.
That makes it easier to plan new studies, avoid over-allocating individual storage conditions and identify capacity that could potentially be released.
For sites managing growing product portfolios or post-approval commitments, getting better use from existing storage can be important. Before investing in additional chamber capacity, it is worth knowing whether the capacity already available is being used as effectively as possible.
One Record, Fewer Hand-offs
Much of the effort involved in a manual stability process is not scientific work at all.
It is transcription, cross-referencing and reconciliation: copying information between records, checking that different documents agree and searching for the information needed to answer what should be a straightforward question.
None of this work adds much value, but somebody still has to do it.
Where sample information, study status and activity are held within one controlled electronic sample tracking system, teams spend less time compiling and checking information and more time on testing, review and other work that genuinely requires their expertise.
The same applies when information is needed for an audit or inspection.
A digital approach can provide:
Study-level visibility
A dedicated study view can show the current position and associated samples without the need to manually cross-check several records.
Complete activity history
Transactions associated with each stage of the process can be captured as the work happens, creating an audit trail as part of the normal process rather than as a separate administrative exercise.
Audit-ready reporting
Information can be retrieved and presented more quickly and consistently, reducing the amount of preparation required when an inspection or internal audit takes place.
Less reliance on individual knowledge
Pull schedules, storage locations and sample activity are held within the system rather than depending on the memory of a small number of experienced colleagues.
That last point can be particularly important. When a process depends heavily on individual knowledge, even routine absences or staff changes can expose just how much of the process sits outside the formal record.
Fitting Into the Systems You Already Use
A stability process does not operate in isolation.
It touches laboratory systems, manufacturing systems and, of course, the people using those systems every day.
The aim should not be to introduce another standalone application that creates more work for the laboratory.
Any digital stability solution needs to fit sensibly with the systems and processes already in place and make information easier to manage, not create another silo that then has to be maintained separately.
That is an important consideration when evaluating any stability sample management software or pharmaceutical sample tracking solution.
Optimising Without Compromising Compliance
Efficiency gains only have value if the process remains compliant.
Any electronic system supporting stability activity must meet the relevant expectations for data integrity and electronic records and signatures, including 21 CFR Part 11 and, for European operations, EU GMP Annex 11.
In practical terms, that means having appropriate role-based access, clear traceability of who performed each action, secure and attributable records and a complete audit trail.
How the system is introduced matters as well.
A risk-based and proportionate approach to validation, aligned with GAMP 5 and the principles of Computer Software Assurance, provides evidence that the system is fit for its intended use without introducing unnecessary validation effort.
Digitalisation should make a controlled process easier to manage. It should not simply replace one administrative burden with another.
Where to Start
Optimising stability sample management does not require a site-wide overhaul on day one.
A sensible starting point is to understand how the process operates today and where the greatest effort or risk currently sits.
Baseline the current process
Understand how pulls, storage locations and documentation are being managed today and how much time is being spent maintaining those records.
Identify the pressure points
Look for recurring pull peaks, capacity constraints, transcription errors, duplicated effort or areas that repeatedly create difficulty during audits.
Define what the system actually needs to do
Requirements should reflect the real process, including any necessary integration with existing laboratory or manufacturing applications.
Plan validation from the outset
The validation approach should form part of the deployment plan rather than being treated as something to address at the end.
Transition in a controlled way
Studies can then be moved across in a structured manner so that compliance and continuity are maintained throughout the change.
The important point is that the technology should follow the process requirements, not the other way around.
Bringing It Together
Digitising stability sample management is often discussed primarily as a compliance initiative, and compliance is clearly a major part of the business case.
But it is not the whole story.
The same changes that improve traceability and reduce compliance risk can also make the stability programme easier to plan, make better use of valuable storage capacity and reduce the amount of time skilled people spend maintaining and reconciling records.
That is often where the case for digitisation becomes clearer.
The question is not simply whether a digital system can replace a spreadsheet or paper record. It is whether the current process is requiring people to spend unnecessary time compensating for the limitations of those manual tools.
DSSWorks from Dataworks is a site-level stability sample management system designed to support this process, providing calendar-based scheduling, storage management, sample tracking, a complete audit trail and audit-ready reporting.
It is backed by more than 30 years of Dataworks experience delivering validated solutions to the life sciences sector, with validation services also available to support deployment.
Is your current stability process becoming harder to manage as study volumes increase?
If you are reviewing how your site manages stability samples, pull schedules or storage capacity, explore how DSSWorks can support a more structured approach to stability sample management.
