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Better regulatory compliance through collaborative planning

Manufacturing is not the only department affected by regulatory compliance issues. In addition to these issues having an impact on good manufacturing practices (GMP), regulatory bodies set ever-stricter standards for quality and documentation.

To retain certification, life science companies need to organize daily sample checks and be prepared at all times for unannounced visits by the regulatory authorities. OMP for Life Sciences enables cross-divisional collaboration on quality and compliance issues to give decision-makers the tools to manage these important issues.

Production meets regulatory compliance

Production meets regulatory compliance

OMP for Life Sciences treats handled regulatory issues as an additional planning constraint, taking into account which in-house or contract manufacturing organization facilities are authorized to produce a particular drug substance for specific customer segments and regions, and in the specified time frame.

This makes it easier to adapt and optimize your planning in response to new approvals (or disqualifications) following inspections by regulatory authorities. It also offers the ideal collaboration platform for S&OP and regulatory compliance teams to share input and co-develop alternative scenarios in response to expected (or delayed) approval dates. From the strategic to the operational level, it takes into account the available production capacity at every node in your supply chain ecosystem.

Aligning with quality assurance and quality control

To boost collaboration between production, and quality assurance and control, OMP for Life Sciences empowers planners and schedulers to take into account throughput times for quality controls. This makes it possible to attribute priorities to urgent batches and get them tested first, to meet critical deadlines, or to prioritize key customers.

Aligning with quality assurance and quality control
Aligning with quality assurance and quality control

Pharmaceutical manufacturing for clinical and commercial production

OMP for Life Sciences breaks down the wall between clinical and commercial products to achieve optimal trade-offs and smooth the research and product launch process. You can, for example, more easily anticipate patent approval to plan commercial production and distribution networks well in advance.

The collaborative portal offers intuitive visualization of both clinical and commercial capacity planning. You can orchestrate both at once, even when clinical and commercial production use the same equipment product lines, or reactors, or where products have been commercially approved for selected indications or patient groups, but may still be at an earlier clinical trial phase for others.

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What our customers say

Stef Vermeiren

“OMP helps us to get all our planners to work together globally, around the same process, using the same system, in the same way.”

Stef Vermeiren, Vice President Global Planning – Janssen Pharmaceutica at Johnson & Johnson

“An optimal supply chain is critical to making sure people, living with severe diseases, obtain their medicines on time. OMP offered the quality and robustness in the planning process we were aiming for. Manual activities from multiple sources are now automated within our new planning system of record. One common integrated process is now applied. This gives better control, greater visibility and a higher level of maturity, resulting in agile supply chains."

Nathalie Loicq, Vice President Global Supply Chain at UCB

“Building our end-to-end planning capabilities on OMP allows us to integrate planning — horizontally, across supply chain, commercial, manufacturing and finance departments, and vertically from the reactive to the strategic horizon. With this, we can take advantage of digital modeling and scenario planning capabilities, and respond quickly to changing business environments, such as we have seen during the pandemic this year.”

Steffen Heinecke, Project Lead for Global Supply Chain at Roche

“In line with our expectations, OMP has proven to be an advanced planning solution. Thanks to the automation and built-in optimization engines, the supply chain team spends less time on trivial, repetitive work and can focus more on value-added activities.”