Qualification & Validation of Systems, Equipment, Facilities, and Utilities

Effective support qualifying your system, equipment, facility, and utilities, or validating your production processes

Qualification and Validation of Equipment, Facilities, and Utilities​

Effective support qualifying your equipment, facility, and utilities, or validating your production processes

We can help you with every step from risk assessment to PPQ

If you need professional and effective support qualifying your equipment, facility, utilities, or validating your production processes – we’re here to help. Pharma IT’s experienced and dedicated consultants are ready and able to assist you across the full spectrum of qualification and validation activities.

Our team can provide the following Qualification and Validation services, as custom solutions, to best meet your needs

Qualification


Qualifying your System, Equipment, Facility, and Utilities



  • CQV activities

  • Preparation and planning qualification and verification activities (DQ, IQ, OQ, PQ, IV, OV, PfV, etc.) to ensure GxP compliance

  • Deviation, CAPA handling & Change Request (CR)

  • Writing, approving and reviewing documents (URS, RA, SOPs, P&ID, design documents, components lists, instrument lists, work instructions, protocols, test sheets, reports, etc.)

  • Commissioning (FAT/SAT)

  • Decommissioning

Validation


Validating your manufacturing processes



  • Cleaning & Sterilization Validation (CIP/SIP)

  • Process Qualification

  • Process Performance Verfication

  • Manufacturing automation qualification (DCS/PCS, MES, ERP)

  • Planning, preparing protocols, test plans (execution of tests, data processing and reporting)

  • Preparing, reviewing SOPs & work instructions

  • Preparing and facilitation of process Risk Assessment

... and more!

Our team can provide the following Qualification and Validation services, as custom solutions, to best meet your needs.

Qualification


Qualifying your Equipment, Facility, and Utilities



  • DQ, IQ, OQ and PQ of equipment, facility and utilities

  • Planning, protocolling, test execution, data processing and reporting

  • Training relevant personnel

  • Deviation and CAPA handling

  • Writing, approving and reviewing documents (URS, RA, SOPs, work instructions, protocols, test sheets, reports, etc.)

  • Commissioning (FAT/SAT)

  • Decommissioning

Validation


Validating your production processes



  • Cleaning Validation

  • PPQ/PV

  • Planning, protocolling, test execution, data processing and reporting

  • Training relevant personnel

  • Deviation and CAPA handling

  • CIP/SIP

  • Writing, approving and reviewing documents (cleaning strategy, cleaning program, process strategy, SOPs, work instructions, protocols, test sheets, reports, etc.)

  • Toxicological evaluations

  • Calculations of MACO and Safety Limits for swab and rinse samples

... and more!

We can assist with all of your quality and compliance needs.

Our goal is to make sure that your organization will achieve and remain in compliance. We strive to increase the quality of your manufacturing processes, to ensure you are able to create safe and high quality drugs for patients.

Rojan Demirtas, Director of Manufacturing

We can assist with all of your quality and compliance needs

Our goal is to make sure that your organization will achieve and remain in compliance. We strive to increase the quality of your manufacturing processes, to ensure you are able to create safe and high quality drugs for patients.

Rojan Demirtas,
Director of Manufacturing

Do you want to know more about Pharma IT's Manufacturing Consulting services?

Pharma IT ensures that all equipment, facilities, utilities and processes are fully compliant

Do you want to know more about our Manufacturing Consulting services?

Pharma IT ensures that all equipment, facilities, utilities and processes are fully compliant

Get in touch