A Progressive Solution
Get right to the heart of pain points and deliver improvements common to all GMP regulated manufacturing.
Take the pain out of GMP Production Digitalisation
Approximately 70% of GMP manufacturing worldwide is still done on paper. Why? Most MES/EBR products available are large and highly complex systems that take too much resource for most companies.
BatchLine Lite MES makes digital GMP production possible for any company.
Our solution is dedicated to solving Pharma, Bio, Cell & Gene, and other similar GMP production company's needs. Our approach is laser focussed on doing so within a realistic budget and demand on customers resources.
Our goal is to make high quality GMP Digitalisation happen, and quickly, prioritising the highest value pains and benefits.
Solving Problems, Bringing Benefits
Manufacturing is a complex business, add in GMP regulations and it gets significantly more so. Providing your teams the right tools is an opportunity to solve significant problems and realise transformational improvement.
60%
Reduction in overall data entry
40%
Average time saved from paper issues
Replace your paper batch record
Unlock all the valuable data in your paper. The journey starts here, it’s the launch pad for all other digital improvements you’ll ever make. Plus, save direct costs from all that paper, printing, archiving, and paper handling time.
Increase your efficiency and reduce cycle times
Vastly reduce time and effort for batch review and approval through review-by-exception, no more reviewing entire batch records. Automate wasteful activities like manually inputting and verifying data, moving paper records around the shop floor, performing and checking calculations, workflow management and more.
Reduction in batch review and approval time
Improve your quality
Reduce quality incidents through digital poke-yoke, check-on-entry, and data integrity controls. Enable right-first-time manufacturing and automatically track related KPI’s. Deal with quality issues at the time through automatic exceptions, with notifications, live monitoring dashboards, and quality analytics to track/trend and manage continuous improvement.
The building blocks of
simplified compliance
All GMP data required for audits and regulatory purposes is automatically tracked and available instantly in simple to follow reports.
Audit Trails
Version Control
Traceability
CSA
CPP / CQA
21 CFR Part 11
US FDA
EU & PIC/S Annex 11
Data Integrity
Qualification
CSV
Electronic Records
Electronic Signatures
Simplify IT management
No more complex hardware and infrastructure to setup and maintain. Let us handle it all for you on world class cloud data centres managed to the highest standards.
Solution by Industry Sector
Pharmaceuticals
Traditional small molecule production of tablets, capsules, liquids, powders, and creams has a variety of complexities which BatchLine’s team have worked extensively on developing and implementing digital solutions for. BatchLine originated from a desire to offer a solution to all the small molecule manufacturers who could never afford MES, this is our sweet spot. Whether its wide process variation, high SKU numbers, changeable packaging requirements, or complex weighing workflows, we have likely experienced it across our deep pool of industry experts.
Traditional Pharma can have the biggest challenges, but with that comes the highest volume of paper and wasted manual work to remove. These often long-standing operations require the right tool, with the right approach, and the right change management, all of which we can help you with.
Biotechnology
BatchLine provides an excellent solution for large molecule Biotech production looking to remove the paper and manual operations around these highly automated processes. In Biotech we take a different approach to traditional MES, which are usually heavily customised to deeply integrate with the process automation systems. Our Lite MES removes the paper and quality review and approval with only minimal integration points in critical areas. This creates intentional compromises to help the customer prioritise where the value truly is without blowing up the project scale and cost, creating a highly efficient and valuable solution for those still reliant on paper and struggling with full-scale MES.
Cell and Gene Therapies
Advanced Therapy Medicinal Products (ATPM’s), or Cell and Gene Therapies, with their small batch sizes, sometimes unpredictable growth rates, and unique material flows are quite different to both Biotech and traditional Pharma manufacturing. We fortunately have had a long-standing relationship with a leading Cell and Gene CDMO, who are a customer and partner of BatchLine, giving us the chance to deeply understand these requirements and develop our product precisely with these in mind.
Cannabis
Manufacture of both medicinal and recreational cannabis derived products have a variety of processes and regulations to handle. BatchLine can be configured to handle these, from simpler local regulations up to full GMP level. As you grow and mature your operations BatchLine's Lite MES fits directly to digitise extraction and manufacturing stages whilst benefiting from our quality and reporting automation tools.
Contract and Development Manufacturers (CDMO’s)
CDMO’s face constant pressure to develop and manufacture products on behalf of their principals, to meet international quality standards for low batch numbers, provide data and oversight to their clients and ultimately to generate profits from each batch. CDMO’s need to be able to create and update product MBR’s rapidly, handle production exceptions and allowable variance compliantly.
BatchLine offers several CDMO specific features for process and review flexibility, get in touch to see and try these out today.
Ready to get started?
Discuss your business requirements with one of our consultants and arrange a demo.
