Contract Manufacturing for Life Sciences
Delivering high-quality life science products on tight timelines — and with even tighter margins — means CMOs and CDMOs need highly flexible and tightly integrated manufacturing solutions.
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MasterControl Offers 4 Key Advantages for
Life Science Contract Manufacturers
Greater Flexibility
Meeting customer demand requires you to constantly scale up or down. But traditional manufacturing execution solutions are too rigid to support regular and rapid changes. And error-prone paper-based processes put you and your sponsors at risk. With the ability to digitally update and maintain batch records, you can scale quickly — within and across customers.
Faster Turnaround
Paper processes create bottlenecks that slow down delivery. MasterControl’s paperless contract manufacturing software reduces the risk of missing tight deadlines or production targets by eliminating the manual management of documentation required for changeover, clearance, and production increases.
Maximised Data Integrity
Missed signatures, incorrect calculations, and illegible entries are inevitable when life science records are manually maintained. With our digital manufacturing solutions, you can avoid these issues that create rework, extend cycle times, and negatively impact product delivery and quality. Plus, you can prevent discrepancies that jeopardise compliance or cause delays.
Enhanced Visibility
All life science manufacturers need clear visibility into their production processes. But CMOs and CDMOs have the added pressure of providing that visibility to their sponsors. Automating your processes with our paperless manufacturing software eliminates data visibility gaps and provides total transparency into statuses — for you and your sponsors.
Master the Capabilities Critical to CMO Contract Manufacturing
Discover strategies to overcome challenges, enhance flexibility, improve quality, and drive operational excellence in this comprehensive guide that empowers life sciences contract manufacturers to confidently navigate the complexities of today's dynamic industry. Learn how to optimise your CMO contract manufacturing operations for growth and success.
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Overcome 3 Key Challenges in Contract Manufacturing for Life Sciences
Production inefficiencies, supply chain complexities, and regulatory hurdles are just a few of the obstacles that can hinder growth and profitability. Learn how to overcome the challenges inherent to contract manufacturing for life sciences and gain insights into how digital transformation can address common pain points. Discover how robust, connected contract manufacturing software can help you conquer obstacles and drive operational excellence.
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Solutions for
Contract Manufacturing for Life Sciences
Ensuring proper documentation and quality management should be the goal for all contract manufacturers from day one. Contract manufacturing organisations (CMOs) and contract development manufacturing organisations (CDMOs) can start product development on compliant footing with MasterControl Development Excellence, part of the fully integrated MasterControl platform.
Product quality is the top priority in contract manufacturing for life sciences. MasterControl Quality Excellence provides automated document control, change control, training management, audit management, corrective action/preventive action (CAPA) management, and unparalleled process connectivity for contract manufacturing. By automating version control, audit trails, and sign-offs, Quality Excellence optimises the handling of multiple products for multiple clients and eliminates the discrepancies that could increase regulatory scrutiny.
Everyone involved in production — contract manufacturers and their sponsors — bears the responsibility for ensuring quality consistency. MasterControl Supplier Excellence helps contractors and sponsors alike ensure quality alignment throughout their supplier ecosystems by combining supplier quality management (SQM), approved vendor lists (AVL), and supplier corrective action requests (SCAR) within the same platform.
Contract manufacturers often struggle to connect quality processes and manufacturing, and too many production lines are still reliant on paper. MasterControl Manufacturing Excellence eliminates paper dependency and automates the last mile of the manufacturing production process, a crucial capability for CMO contract manufacturing operations.
Once a product is on the market, its performance must continually be monitored. MasterControl Postmarket Excellence helps manufacturers track customer complaints and resolve issues efficiently, making it easier for contract manufacturers and sponsors to uphold product quality and maintain consumer trust.
Resources for Contract Manufacturing
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GxP Lifeline Blog Posts
Quality Agreements With Contract Manufacturing Organizations (CMOs)
To maintain a competitive edge, companies in the life sciences are increasingly reliant on contract manufacturing partners. From the FDA’s perspective, these partnerships mean that both product owners and their contractors are responsible for cGMP compliance. Learn how CMO quality agreements help both parties uphold compliance.
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Optimizing Pharma CMO Supply Chains: 3 Steps to Boost Flexibility
Contract manufacturers in the pharma industry can count on one thing: the inevitability of supply chain disruptions. But reacting appropriately to destabilizing events requires a great deal of flexibility – a trait that’s difficult for most companies to develop. Learn three steps pharma CMOs and CDMOs can take to optimize supplier management by enhancing the flexibility of and visibility into their supply chains.
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Maintaining Supply Continuity: 3 Ways to Ease Pharma CMO and CDMO Worries
As we cope with the aftermath of COVID-19 in these uncertain times, it’s critical for pharma outsourcers to control the controllable aspects of supply continuity. These three practical steps will prepare pharma CMOs and CDMOs to handle the supply continuity challenges that will inevitably arise.
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Disruptive Outsourcing Means Life Sciences Are Relying on CMOs More Than Ever
Life sciences manufacturers’ reliance on outsourcing is on an upward trajectory. However, recent disruptions to how and why companies turn to contract manufacturing organizations (CMOs) and related contract services are changing the playing field. To maintain quality and control of products in this more dynamic outsourcing ecosystem, companies should seek greater collaboration.
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Contract Manufacturing Case Studies
Accelerating Life Science Contract Manufacturing With Electronic Batch Records
Discover how a CDMO has reduced production cycles from months to days, passes frequent inspections quickly, closely adheres to demanding GMP quality standards, and delights their clients by delivering on-spec therapeutics in a timely manner.
Fueling Growth Through Digital Transformation
See how connecting batch records and quality processes within an integrated platform has enabled an FDA-registered 503B compounding facility to increase visibility into actionable data, maximize efficiency with automation, and put controls in place to ensure processes remain compliant at every step.
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Begin your life science contract manufacturing optimization journey.
