InstantGMP: Electronic Batch Records System for GMP Manufacturing InstantGMP™ Inventory Control Module for GMP Manufacturing

InstantGMP: Electronic Batch Records System for GMP Manufacturing GMP: Challenges of Traditional Systems  Inventory control of GMP materials is a complex process. Wide array of regulatory requirements Time and expense needed to set up an automated system Difficult to keep up with individual entries if system is not centralized and available to all users Keeping track of depletions and shipments is laborious Compliance can be resource intensive InstantGMP™ has an inventory control module that was built from the ground up to meet these challenges

InstantGMP: Electronic Batch Records System for GMP Manufacturing InstantGMP™ - A new approach to GMP manufacturing  Electronic Batch Records System for GMP Manufacturing  Seamlessly incorporates everything necessary for GMP manufacturing in one place  Cloud-based application makes all data visible to everyone at all times  Uses built-in quality procedures to make GMP compliance easy  Provides more flexibility, visibility and productivity than paper based manufacturing

InstantGMP: Electronic Batch Records System for GMP Manufacturing Automated Compliance cGMP compliance controls are built into the system  Part numbers automatically assigned to all materials  Materials quarantine/restricted until QA approval of vendors and specifications  Specifications system has automated version control  Purchasing restricted to approved materials and vendors  Digital signatures at specified steps record person and date/time  Limited access based on user/role security settings  Complete automated audit trail

InstantGMP: Electronic Batch Records System for GMP Manufacturing Inventory Control  Inventory use tracked at every transaction  Part numbers assigned automatically  Specifications management with version control  Purchase requisitioning with quality checks built in  Automatically generated purchase orders  Material receipt and warehouse recording  Quality status controlled only by QA  Depleted inventory shows what materials have been used up

InstantGMP: Electronic Batch Records System for GMP Manufacturing Distributed Vendor Capability  Company can use several vendors for each of their materials  Each vendor can enter individual inventory updates for each item in inventory  System monitors who entered what and when  Company can track complete picture of inventory use, history and amount across multiple sites

InstantGMP: Electronic Batch Records System for GMP Manufacturing 7 Tracking of Inventory Distribution

InstantGMP: Electronic Batch Records System for GMP Manufacturing Summary  Inventory system includes control over Materials Vendors Specifications Status and use  Can be used for materials distributed over multiple sites or vendors  Easy to use and visible to all authorized users over the web

InstantGMP: Electronic Batch Records System for GMP Manufacturing Quick Facts  Developed by the manufacturing and quality experts at PharmaDirections  Integrated internet based application developed through “Quality by Design” approach  Standard Operating Procedures and Policies come with the application  21 CFR Part 11 Compliant  System has been in use since 2004

InstantGMP: Electronic Batch Records System for GMP Manufacturing InstantGMP™ Summary  Electronic Batch Records system for GMP manufacturing contains inventory control module  Takes full advantage of cloud-based application  21 CFR Part 11 compliant database with SOP requirements hard coded into the software  Simplifies the documentation and approval procedures to reduce time lines and increase visibility  Ideally suited for any GMP manufacturing such as APIs, drugs, OTCs, generics and dietary supplements  For more information, contact:

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