Montrium played a pivotal role in our efforts to formalize our Document Management and Quality Management Systems. Their team provided expert feedback during the design and configuration phases and continues to provide exceptional customer support services.

Before implementing SOP Connect and Training Connect from Montrium, our process was manual, inefficient, and archaic. Since then, the process has become streamlined, resulting in increased productivity, organization, and positive results through multiple successive audits from various regulatory authorities

Jeiven Pharmaceutical Consulting has partnered with Montrium on numerous audits of IXR systems on behalf of our clients. Montrium’s expert auditors have worked with us and our clients on global projects and have provided qualification audits as well s remediation help. For many of our clients, the IXR system is intimidating and confusing and Montrium is always so helpful in working with our clients to convey highly complex terminology in ‘everyday’ language.

Montrium’s expert Professional Services team worked with us to formalize our Standard Operating Procedures (SOPs) and our Master Validation Plan. We also worked closely with their team to validate our network infrastructure and data collection software. Their professional and experienced team ensured that we implemented a strategy that was not only in alignment with our pharmaceutical clients’ requirements but also the relevant regulatory requirements (21 CFR PART 11).