FDA regulated industries are faced with implementing electronic controls, document risk assessments, and records requirements. In 1997 the United States Food and Drug Administration issued 21 CFR Part 11 regulation entitled Electronic Records and Electronic Signatures.

M & R Pharma provides a full range of compliancy support, audits, remediation and technical assistance to industries regulated by FDA in the pharmaceutical, life sciences, and medical device industries.

M & R Pharma works with our client's towards compliancy by preparing a compliance strategy, systems and process audits, package selections, application remediation, and program management.

M & R Pharma provides validation services and GxP regulatory compliance services, IT lifecycle, computer system validation, software quality assurance, project management, gap analysis, reporting, planning, SOPs, change control, and remediation services.