You are a Biotech and life sciences manufacturer. You thrive on innovation, product quality, and customer safety. Meeting ISO, FDA, and other regulatory requirements is a key driver to getting your products out the door, fast.

LeanEra can help you gain control over the quality, process, and audit requirements that spell high levels customer safety and satisfaction. Here are some of its key features:

  • Manage suppliers and ensure material quality accountability
    • Supplier performance evaluation
    • In-coming material QA process
  • Achieve customer satisfaction and excel at customer care
    • Manage custom-made products
    • Provide after sales services with supporting production data
    • Provide proper return goods process
  • Lot control
    • Complete lot information for each lot controlled product
    • Complete life of lot traceability reporting for FDA CFR 11 and ISO3845
    • Lot expiration tracking
  • EDI ability
  • Security and audit trails: access control and change log to support FDA audits/reporting
  • Process and guided procedures
  • Manage and track R&D projects: documents, materials, and labour time