Factorytalk's Compliance Services team specializes in helping regulated industries establish efficient, cost effective quality systems that will pass inspection and produce high quality products. We also review current systems to make them more efficient and robust enough to stand up to current regulatory challenges.

• Project Management: We assist with management strategies, tailored for companies that want to set up the most cost effective and efficient compliance infrastructure possible with limited resources.
  
  
• Auditing: We perform all types of GMP Audit and provide very detailed, specific and practical reports and recommended actions, including full references to the pertinent regulations and guidance documents.
  
  
• Quality Systems: We review, implement or improve any Quality System, including all those for QA, Manufacturing, Laboratories, and support groups.
  
  
• Process Validation: We set up a process validation program that will pass inspector scrutiny, everything from writing the SOPs and Master Plans to writing and executing the protocols and summarizing the data into usable reports.
  
  
• Computer Validation (CSV) : We help develop Master Plans, SOPs, and protocols required to make sure your systems are fully validated and compliant with PIC/S, WHO or US FDA (21 CFR Part 11) requirements.
  
  
• Facility / Utility Monitoring: We review your current Facility and Utility Monitoring programs to ensure they are robust enough to pass inspection. We can help you analyze locations and points that show frequent excursions for how to correct the situation. We can also analyze data, create trend reports, and write validation protocols.

• Regulatory Affairs:
  Maintenance of marketing authorisations (dossier maintenance), including translation and updating of marketing authorisation documentation, reformatting from NTA to CTD to eCTD, providing expert reports and processing deficiency letters.
  
  
• Business Development:
  We act as a broker for the perfect product or company. Using our international network, we perform a targeted search for suitable cooperative ventures, sales partners or acquisition candidates (M&A).
  
  
• Training: We bring training programs to your site and we offer several courses a year at various international sites.