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DOCUMENTATION

INDUSTRY BEST PRACTICES

An important step in the implementation of you compliant Pharmaceutical Quality System is to have the correct documents to enable compliant and efficient within your facility.  We provide Quality System documentation expertise in:

  • Quality Assurance. We have assisted clients to build their suite of Quality Assurance documentation, including Quality Policies, Quality Manuals, Supplied Quality Management Programs, Quality Risk Management, Data Integrity, Batch Release, Good Documentation Practices, Area Clearance and Batch Release to name a few.

  • Engineering. We specialize in all things engineering and have provided in depth support to clients in the development of their Calibration, Maintenance, Facility, Clean Utility, HVAC and Equipment policies and procedures. The documentation that we have produced have been through multiple FDA, EU, TGA and Indian regulatory audits without issues. 

  • Validation. We assist our valued client build up their internal Policies, Plans, Procedures and Forms to ensure compliant and efficient validation activities. We have developed Site Validation Master Plans, Equipment / Utility Validation procedures and protocols. 

  • Project Management. We can provide project management support for your QMS implementation project. Ideally we incorporate ourselves with your site based team and implement efficient project management methods. 

  • Training. As part of building up the document repository we provide training presentations to train the internal site teams in the new procedure. This helps the site team understand the new procedure and speeds up the implementation process. These training files can also be implemented within your QMS for ongoing training related to the documentation.  

 

We work in collaboration with your onsite team and our Quality System partners to support your PQS implementation project. Quality, compliance and project delivery are at the core of what we do. We have tried an trusted templates across the entire quality operation. Get in contact today to see how we can assist.