Quality is at our core

As a Quality Assurance leader for over 10 years, Montrium adds value to your quality assurance practices by embedding domain expertise and quality into your processes. We focus on increasing the level of quality while reducing the overall costs associated with process outputs. Our Professional Services team can help you identify the problems areas of your controlled processes throughout all phases of pharmaceutical drug development and pharmaceutical manufacturing to drive new efficiencies and to promote transparency.

Our Quality Assurance Services

Montrium has a network of Quality Assurance and regulatory specialists both in North America and Europe who have an in-depth understanding of regulatory requirements and best industry practices. Our network provides a comprehensive QA framework, quality assurance assistance and quality oversight to help you meet the regulatory requirements. In addition, our Quality Assurance experts are able to evaluate your existing QA processes to ensure that they are current, and you are using the necessary best practices, as well as assisting you in the creation and review of standard operating procedures (SOPs) and quality issues management.

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Our Quality Assurance Services

Montrium offers a comprehensive range of Quality Assurance and GxP regulatory requirements services to support the different aspects of pharmaceutical development management and processes based on proven methodology and best practices.

Montrium has extensive experience in auditing computerized system vendors against regulatory requirements. We have undertaken many different audits over the years for many different systems in all areas of GxP. We focus on ensuring that systems are adequately documented and validated. We also evaluate whether systems are fit for their intended use and whether they are a good fit for our clients.

Montrium is able to offer remote Quality Assurance services for smaller organizations who do not have a dedicated independent quality assurance resource. Our services can be combined with our Quality Management workspace to provide you with a combination of quality assurance oversight and a fully electronic quality management system. This approach means that we can facilitate collaboration between our Quality Assurance experts and your internal teams, whilst ensuring that fully compliant electronic quality records are properly maintained.

Montrium offers services for the independent QA review of system documents in accordance with regulatory requirements and SOPs (Client or Montrium). We have experience reviewing the following documents:

  • System Specifications
  • Validation Plans
  • Risk Assessments
  • System Descriptions
  • Validation Testing Documentation
  • Validation Summary Reports
  • Change Controls

We can provide this review as part of an ongoing Quality Assurance oversight mandate or on an ad-hoc basis. We review this documentation against relevant regulations, SOPs and industry standards such as GAMP5.

Montrium offers an SOP writing and review service to assure compliance with the current GxP requirements based on an initial Gap Analysis. Montrium can assist in the preparation of SOPs that support the ongoing activities of our clients in addition to providing guidance for the implementation or revision of SOPs and forms to ensure compliance with regulatory requirements. We can also provide standard templates of SOPs, forms and checklists developed in compliance with ICH guidelines, FDA CFRs, EMA directives, Health Canada regulations and industry standards.

We have experience implementing and reviewing SOPs for the following:

  • Clinical Data Management
  • Biostatistics
  • Quality Assurance
  • Information Technology and Computer Systems Validation

Please contact us to learn more about the specific SOP services you are interested in.

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Jeiven Pharmaceutical Consulting, Inc. has partnered with Montrium on numerous audits of IXR systems on behalf of our clients. Montrium’s expert auditors have worked with us as well as our clients on global projects, and have provided qualification audits as well as 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.
Validation Accelerator Pack

Standard IT SOP Templates Pack

Are you looking to put in place a standard set of SOPs to govern your electronic system?

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