Essential GMP Documentation Services
Mediviz has holistic and time tested experience in preparing and reviewing of documentation for any kind of audits of Pharmaceutical Companies and accepts assignments for Good Documentation and GMP Documentation practices development as per the customer’s need. Conformity to set standards is the goal and Mediviz ensures this in good measure.
Designing of client’s documentation system is also undertaken to meet international standards of USFDA, WHO, EU, PICS, TGA, ICH Q7, MHRA. The documents shall include QMS, Batch documentation, Validation, Recording forms, formats, SOPs and all associated GMP documentation. Mediviz reviews the firms SOPs for performance and compliance and also provides the clients, prototypes (templates) of few SOPs based on which the client are expected to prepare and expand their respective SOPs.
Mediviz also assists the client in preparing master GMP documentation where ever required. Mediviz also reviews the SOPs for regulatory compliance once they are prepared by the firm to ensure technically accurate and resources are available for their execution.
The GMP documentation team at client’s end shall also be trained to enhance and sustaining their GMP documentation on a regular basis.
Mediviz works in unison with experienced and highly skilled professional and global GMP experts to benefit its clients besides adopting a cost effective method towards documentation.