CATEGORY: Maintenance Quality

Maintenance Quality services will help your organization to maintain a sound Quality System for production and manufacturing operations.  It can be described as the thermometer of your whole operation in terms of GMP compliance. 

Maintenance Quality will help your organization to clearly describe those responsibilities for your Quality Unit (Quality Assurance and Quality Control) in relationship with maintenance, research protocols, inspections (i.e., internal audits), and testing programs.  The use of sound statistical approaches for validation of processes, cleaning methods, CAPA investigations, and performance qualification of your equipment and laboratory instruments, will help you to consolidate a respectable Quality System and build a stronger working relationship with your customers and suppliers.  Not to mention that it will also guarantee quick and scientifically-supported responses to inspections from clients and regulatory agencies.

Some of the services that our group provide in this Category are:

  1. Standard Internal Audits

  2. Quality Gap Analyses

  3. Development of Corrective and Preventive Actions (CAPA) Investigations

  4. Root Cause Analyses

  5. Recall Training

  6. Process Validation

  7. Cleaning Validation

  8. Equipment Qualifications (IQ and OQ) and Validations (PQ)

  9. GMP Compliance with US FDA 21 C.F.R. parts: 110, 111, 210, 211, and 820

  10. Good Laboratory Practices (GLP)

  11. Environmental Monitoring

  12. Preventative Maintenance

  13. Equipment and Instruments Calibrations

  14. Literature Research

If you are in need of a service not listed here but associated with this Category, we highly encourage you to contact us by following the link below ...

307 SW 16th Ave, Suite 301

Gainesville, FL 32601 U.S.A.

Tel: 786.514.6171

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