World Quality Week offers the life sciences industry an opportunity to reflect on how quality drives progress, not only in the products themselves but also in the processes that bring them to market. One critical challenge is jurisdictional control. Differing global regulations can delay batch release, leaving products idle when they should be reaching patients. To advance quality in this context, organizations must modernize how they manage regulatory complexity, streamline approvals, and improve coordination across systems.
Jurisdictional rules layer approvals, making change a challenge. Even a relatively minor change upstream—such as a new testing site or product formulation—can cause the disposition process of a company shipping numerous products across many jurisdictions to splinter into hundreds of potential paths.
Integrations between different systems—each responsible for a discrete aspect of the batch disposition process—is how companies have traditionally managed jurisdictional control. When many suppliers, materials, and markets are involved, this approach places a heavy burden on teams. Disconnected data and manual processes across production, quality, and regulatory functions also create bottlenecks while coordinating activities. Bringing together quality and regulatory systems improves change control and enables review-by-exception.
Operating too cautiously adds to costs
Since market ship approvals are time-bound, fluctuations in raw or intermediate materials or finished goods can slow things down. Managing the interplay between regulatory approvals in every jurisdiction, change control procedures, and the can ship/may ship/must ship framework (and its variations) is the responsibility of the disposition owners and qualified persons (QPs).
If a change occurs, decision-makers assess supply chains and identify connections between raw materials, finished goods, and production locations. Two scenarios can trigger this:
- Switching product materials: After a specified “must ship” date, products made from the old pre-change material will no longer be accepted. If supply chains are not ready by this cutoff, companies might build products that are not allowed in the market.
- New suppliers: During the changeover across suppliers, batches that are already qualified for a given market cannot go out until the “may ship” date. This can lead to goods accidentally being sent to a market that isn’t able to receive them.
Organizations that can’t see a complete picture for each batch and market are usually more cautious, choosing not to ship products to avoid mistakes, even if it risks operational delays. Regulatory, operations, IT, quality, and supply chain teams work together to minimize inventory carry, but manually locating documents for every batch across systems strains resources. Even once a market ship decision is clear, managing the process in this way increases compliance risks. For example, the process lacks an audit trail showing due diligence was completed and batch release validated as part of the good manufacturing practice (GMP) process.
The outcome is higher inventory costs and slower time to market. Considering this occurs over hundreds of market ship countries, big product portfolios, and countless suppliers, upstream changes can significantly impact outcomes.
Making review by exception a reality
By unifying relevant content and data on connected applications, disposition owners and QPs can prove compliance for every batch. A quality management system (QMS) tracks deviations and change controls, a quality document management solution enables viewing of certificates and reports (e.g., from manufacturing partners), and a lab information management (LIMS) application delivers testing lab reports.
Connectivity with registration data in regulatory systems helps companies move forward after upstream changes: decision-makers can pull in and assess market approvals through change controls. Application programming interfaces (APIs) integrate other solutions that are not part of the quality ecosystem, including labeling and artwork, warehouse management, and manufacturing execution (MES), as well as documents in enterprise resource planning systems (ERP) relating to materials, batches, and genealogy.
Lab Quality Management Certificate
The Lab Quality Management certificate is more than training—it’s a professional advantage.
Gain critical skills and IACET-approved CEUs that make a measurable difference.
In this environment, quality decisions are sent directly to the ERP for processing and quickly followed by a market release decision. Disposition owners and QPs are then able to review a summary of restrictions before moving a batch forward, facilitating “review by exception.”
Disposition owners need clear, simple instructions confirming each batch is compliant for shipment. Looking ahead, automation will further remove friction when validating regulatory compliance. Linking change controls with country-specific approval statuses enables the system to analyze releasability, provide guidance on regulatory restrictions, and show new information in real time, such as registration changes. Green for “go” and red for “no” on each market will become the standard, replacing today’s emails and calls.
Real-time warnings will soon also become the norm, highlighting to disposition owners and QPs when they shouldn’t move ahead with shipping. Because all markets are connected and visible within a change control, the system can prevent batches from being released that are linked to a market that has issues. This saves time and costs, significantly impacting a company’s bottom line.
For companies managing dozens of jurisdictions, automated shipping will help simplify the process. The system will be able to specify on a per-batch basis whether each market is released. Over time, technology will address market restrictions further upstream, such as during ordering and supply. Instead of building batches that can’t be used, teams identify issues ahead of time and divert them to acceptable markets.
With connected systems and automation, organizations can gain full visibility into batch status and market restrictions, achieving true jurisdictional control. Quality and regulatory teams can act with confidence, knowing that every release decision is backed by current data and complete traceability. As companies continue to evolve their quality systems, this alignment will help prevent unnecessary delays, reduce costs, and ensure products reach the markets and patients that need them, delivering on the core principles recognized during World Quality Week.
