InformationLeader has helped exporters meet stringent US FDA, EU, Japanese, and Australian requirements for over 10 years. Its feature set has been designed from the ground up to not only get on top of compliance requirements, but to turn compliance into continuous improvement.

Single site. Multi site. Export or domestic. Big and global or local and agile. InformationLeader is flexible enough to meet your specific Quality Assurance requirements.

Capture

  • Track Product Hygiene Indicators (PHI) in an automated system.
  • Data capture that meets and exceeds CFR 21 Part 11 requirements for electronic record keeping.
  • Implement your own HACCP, GMP, ISO Accredited plan with highly flexible data forms.
  • Proven track record for meeting US FDA, EU, Japanese, and domestic data capture requirements.
  • Only electronic system confirmed by a government department as meeting all Australian State & Commonwealth Electronic Transaction Acts, Australian and International standards for record management, and the guidelines for the management of IT evidence.
  • Pre-operation, process monitoring, hygiene assessments, micro, and documentation review all in the one system.
  • Data validation and automated notifications customised to how your business operates and your own targets as well as according to client specifications.
  • Link to existing software systems to avoid duplication and minimise inconsistencies.
  • Capture text, barcodes, pictures, documents, handwritten signatures, and more.
  • Electronic signature capture that meets and exceeds record keeping requirements.
  • Start with QA, move on to customer complaints, maintenance, lab, environmental and OH & S with the same system.

Manage

  • Corrective action requests raised automatically and in real time for out of spec results.
  • Preventative action requests scheduled with automated reminders.
  • Customisable workflows to fit what works best for your business.
  • Full audit trail that can be analysed – identify hold ups, average response times, and more.
  • Automated escalation that notifies the right people when the wrong things are happening.
  • Document review notifications make sure document review deadlines are always met.
  • Ensure everyone is notified when new policies and procedures are rolled out.
  • Everyone working with the right template and procedure versions, at the right time.

Report

  • Certificate of analysis, pre-shipment reviews, process monitoring and many other reports generated with your company logo, fonts, and format at the click of a button.
  • Monitor PHI information and track improvements with visual representations of objective data.
  • Use reporting to identify trends and areas to focus on.
  • Scheduled reporting means that data is automatically compiled, formatted, and sent to you via email.
  • Standardised letters and summaries tidy up information and tailor it for individual stakeholders.
  • PDFs, Microsoft Word, Microsoft Excel, or XML output for every report provide flexibility.
  • Report over data captured in InformationLeader as well as other systems in your network.