Good documentation practice constitutes a necessary part of the Quality Assurance system. Clearly written standard operating procedures (SOPs) avoid errors of oral communication and ensure tractability of history of changes. The SOPs are expected to cover all functions and need to structure in a comprehensive language the details of the necessary steps, the decisions to make and the possible outcomes.

Our SOP and system implementation services include:

• SOPs development, review, update and implementation according to business needs
• Flexible design and calibration of procedures to implement in application the theoretical know-how background of business partner’s resources
• Assistance with routine and ad hoc regulatory authority requests and interactions
• Periodic compliance review
• Provision of a comprehensive Quality Management system