Challenges to Overcome

The biotechnology segment in the global life sciences industry continues to grow at a rapid pace due to technological advancements and availability of low-cost biosimilar drugs. But this rapid growth has resulted in an increase in competition too. As a result, biotechnology manufacturers are pursuing ways to deliver these drugs at an affordable price without compromising on safety and quality. In doing so, they face challenges such as stringent regulatory compliances and safety requirements, and need to shorten the product development cycle, among others.


Solution

A solution that understands the complex needs of this industry is BatchMaster ERP for Biotechnology, tailor-made for this segment and its obligatory regulatory compliance needs which include adherence to cGMP requirements as well. BatchMaster ERP for Biotechnology can very easily map biotech companies’ basic as well as complex business processes like formulation, batch management, supplier verification, generation of BMR etc., and provide real-time information of all the departments, which helps manufacturers to streamline their operations and take timely proactive informed decisions to outlast the competition.

Key Features

  • Raw material planning and procurement
  • Supplier/Vendor management and qualification
  • FDA 21 CFR part 11 compliance, which includes secured master data management
  • Quality Control (QC) with sampling plan, stability testing
  • Quality Assurance (QA) as per cGMP norms
  • Opportuity tracking, sales, delivery and invoicing
  • Inventory management, including material characteristics such as potency, catch weight, classifications, expiration dates, lot control, and varying units of measure
  • Support to contract manufacturing
  • Batch monitoring activities by inspection plan
  • Formulation management: Complete formula security with audit trail and approval workflow. Also includes by-products, co-products, intermediates, variations in expected yields, and alternate equipment-specific formula
  • Electronic execution of SOPs by inspection checklist
  • Electronic batch ticket, electronic weigh sheet, and manufacturing batch record (MBR)
  • Non-conformance (NC)
  • Corrective and preventive action (CAPA)
  • Easy material substitutions
  • Multiple packaging of same formulation
  • Shelf life/Expiration support
  • Bi-directional lot traceability and lot recall
  • Separate granular costing of formula and packaging material
  • 'What-if' analysis and various costing methods for increased margins
  • Adverse event/Complaint reporting
  • Allergen management
  • Mobile warehousing: Employment of handheld RF devices to execute material movement and adjustments within one or more facilities
  • Dedicated module to handle all complaints, returns and recalls
  • Master Production Scheduling (MPS)
  • Material Requirement Planning (MRP)

Benefits

  • Streamlined operational process flow and enhanced profits
  • Business efficiency
  • Cost control through reduced wastage, optimum material utilization, and inventory management
  • Real-time batch monitoring to make accurate business decisions
  • Greater customer satisfaction by swift response to customer demands
  • Assured quality and timely supply
  • Competitive advantage
  • Support for cGMP, and other stringent compliance regulations
  • Expanded approval controls
  • Enhanced speed to introduce drugs to market that are cheaper than the competitors
  • Ability to maintain formula secrecy

Cloud Deployment Available

Give your small, mid-size, or large-scale businesses the power of our ‘Cloud ERP’ solutions, and enjoy the benefits of leveraging the cloud.



Integrate. Extend. Excel.

BatchMaster ERP with SAP BusinessOne
ERP integrated with Microsoft dynamics GP
BatchMaster ERP for Sage 100/300
Manufacturing ERP with Tally ERP9
Manufacturing ERP with QuickBooks
Magento ERP Integration
BatchMaster finance module
BatchMaster Human Resource Management Software

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About Us

BatchMaster Software is one of the market leaders in offering enterprise software solutions for the process manufacturing industries. With an in-depth industry analysis, gained through a vast industry experience with over 2000 implementations worldwide, we clearly understand the unique industry challenges. BatchMaster offers ERP solutions that are apt to support industry specific operations and handles critical processes of the micro-verticals. Process manufacturing companies around the globe have come to rely upon BatchMaster® to manage nearly every aspect of their manufacturing distribution, finance & accounting, Quality Control, Compliance and HR- related operations. With headquarter in Laguna Hills, BatchMaster has its offices in New Jersey, India and New Zealand.
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