Documentation Services

CoralPT has holistic and time-tested experience in preparing and reviewing 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 CoralPT 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. CoralPT reviews the firm's SOPs for performance and compliance and also provides the clients, prototypes (templates) of a few SOPs based on which the client is expected to prepare and expand their respective SOPs.
CoralPT also assists the client in preparing master GMP documentation where ever required. CoralPT 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 the client’s end shall also be trained to enhance and sustain their GMP documentation on a regular basis.
 
CoralPT 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.