How it started
The pharmaceutical industry is heavily regulated. National and international standards and requirements are becoming increasingly important, if not essential to the conduct of business.
Regulations set up guidelines that manufacturers should follow. They impose an obligation for pharmaceutical companies to develop processes and quality assurance programmes in accordance with the principles. Organisations must enable their stakeholders to work towards continuous improvement and monitor documents and data integrity.
Companies are devoting substantial resources to compliance and process validation. Due to the vast number of regulatory documents and working practices in the pharmaceutical industry, manufacturers need a reliable and effective system to support compliance.