Qualification Validation of processes

Qualification & Validation of processes, equipments and computer systems (CSV)

Quality is the most important requirement in the manufacturing process for every pharmaceutical and healthcare company, as the trend towards automation in manufacturing accelerates, outsourcing Good Manufacturing Practice (GMP) validation activities plays an indispensable role in quality management, liability consolidation and enhance the enterprise’s overall performance.

In order to assure Quality, our experts help control each critical manufacturing step carefully, be it documenting evidence to assure consistency of process or ensuring new equipments operates within the established limits or validating computer system to automate parts of manufacturing process.

Benefits of Qualification and Validation

From GMP and Regulatory point of view, these activities are mandatory for all healthcare players but the benefits goes beyond just compliance with FDA and successful audits:

Some of the most notable values of Validation System to healthcare businesses are:

  • Good traceability
  • Security & Accuracy
  • Risk Mitigation
  • Continuous Improvements
  • R&D Cost Reduction
  • Reliable and Consistent results

Why Amaris Consulting?

At Amaris, we understand this competitive scenerio and the critical demands for validation with highly skilled and knowledgeable experts, our team is dedicated to drive positive impacts to our clients and be able to support them with:

  • Process Validation: identifying, monitoring and variation management
  • Equipment Validation: audit trail, different access levels, auto-logout function, date & time system, account blocking or saving function.
  • Computer system and software validation:
  • Cleaning Validation:

Check out what one of our expert says about paperless validation click here.