In-House GMP-Compliant Manufacturing
Standard NetSuite software can accommodate generic manufacturing solutions; however, it is not ideal for cell therapy and gene therapy situations. By enhancing the basic NetSuite software with our industry-specific IP, we’ve created a scalable platform that has all the tools necessary for a GMP-compliant process.
For pharmaceutical, cell therapy, and gene therapy companies, manufacturing compliance used to only be handled on paper since online solutions couldn’t handle their needs. With our manufacturing bundle, you get GMP/GxP-compliant manufacturing bases that rival Tier 1 solutions for a fraction of the cost.
NetSuite Core Manufacturing
We took the core, scalable NetSuite system and developed an industry-specific IP that allows for a variety of manufacturing solutions, including:
- Barcoding/warehouse management solutions (WMS)
- Picking, packing, and shipping
- Manufacturing WIP
- Routing/advanced marketing
- Demand planning
We also offer quality management, which includes quality specifications and inspections, table data collection, reporting, and integration. All of our manufacturing solutions work in tandem with our CMO supply chain solutions so we can be a one-stop shop for all of your manufacturing and distribution needs.
AdaptaLogix Manufacturing Bundle
The AdaptaLogix manufacturing bundle is centered around GxP guidelines and regulations. GxP stands for Good (G), Practices (P), and variables based on application (X). The x variable could be M for manufacturing, C for clinical, L for laboratory, S for storage, D for distribution, or R for review. These GxP guidelines were created by the FDA and ensure that pharmaceutical products are safe, meet their intended use, and adhere to quality standards and processes for manufacturing, control, storage and distribution.
When you work with AdaptaLogix and utilize our manufacturing bundle, you’ll have peace of mind knowing we follow all GxP guidelines and regulations. The bundle includes:
- GxP vendor onboarding
- GxP material onboarding
- Approved suppliers/materials list
- GxP purchasing process
- GxP inventory process
- GxP manufacturing process
- GxP final product release
- Security configuration
- CFR 21 part 11 compliance
- Dashboards, reports, and alerts
GMP Validation Services
When you need to validate your GMP system, AdaptaLogix is ready to take care of it. Due to the way we set up and document our manufacturing, the validation process is already largely finished (around 80%) by the time we’re done with everything. The remaining validation services needed are handled in-house, meaning you won’t need to use a third-party resource that can take more time and money. For simple, accurate GMP validation services, partner with AdaptaLogix.
Let AdaptaLogix Help
The fact that our entire consulting staff is GAMP5-certified means we are trained to write entire standard operating procedures, accurately basing them off industry-specific best practices. All system validation is done in-house, so we truly take care of the whole process.
“We’re not collecting your system requirements; we are confirming them.” — James Neal, Founder, Managing Partner
Get GMP-Compliant Manufacturing
Our GMP-compliant manufacturing services are available for pharmaceutical, cell therapeutic, and gene therapeutic companies around the world. The AdaptaLogix solutions are mostly catered to companies in phases 2, 2B, and 3, but we can assist you no matter what stage you are in.
For GMP compliance, GMP, GxP, and FDA validation, and a personalized system that fits your company’s unique needs, you want the AdaptaLogix manufacturing bundle. This bundle streamlines your compliance and validation requirements, ties in with all of your manufacturing processes, and makes the process simple and straightforward for your company.
You can get in touch with the AdaptaLogix team to discuss compliance and validation options to see what fits best for your company. Additionally, you can schedule a demo to see how our NetSuite system works.