QMS Advisory

Digitalise your Quality, Clinical, Pharmacovigiliance and Regulatory processes leveraging Cloud Platforms

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How our QMS experts are setting a president for high quality QMS processes

Upgrade from outdated paper-based or generic systems to modern, cloud based solutions

We are recognised for delivering the highest quality services and solutions, with total reliability, through always acting with integrity, transparency and honesty. Rephine offers a full range of services in strategy, consulting, implementation and post implementation that help customers hitting the Pharma 4.0 for a more personalised healthcare and better patient outcomes. Our approach is agnostic, allowing us to support any Quality Management System (QMS).

Our QMS Services

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Initial Strategies

As life science experts we have a powerful team to support business, technology and data management processes. Main activities: Consulting on process transformation, Products and vendors evaluation, Roadmap development, Preparation of business cases, Development of Phase 0 projects.

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Platform Implementation

Deeply experienced GxP consultants will support your Quality, Clinical, Regulatory and pharmacovigilance software implementation and configuration after rigorous certification programs from vendors. Adopting Agile methodologies and broad expertise, we will speed up the Time to Value and reduce the risk of the project.

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Validation

We have a validation team that helps the customer to validate the configured system according to their requirements and computer system validation policies, following the complete system lifecycle and reducing the time required for Go-Live.

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Change Management and Training

A crucial process to maximise the success of your implementation. Successful and sustainable change can only be achieved when everyone is on board.

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Managed Services

Maximise the success of your platform and reduce your global IT costs through the implementation of new processes, configuring enhancement or rolling the processes out in new sites, divisions or business areas. Release management is an important part of the post go-live support. Engage and trust our experts for a comprehensive adoption of the new features included in each release.

Benefits for our clients

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Streamlining the operational workflows to maximise business efficiency for each customer

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Increase visibility and control over regulated data across all GxPs areas

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Reduce the total cost of ownership by adoption of cloud technologies in the quality and regulatory areas

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GxP practitioners and business consultants implementing solutions for your business processes

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Compliance with cGMP, 21CFR Part 11 and Annex 11 of EU GMP

Our QMS Partners

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Master your QMS
implementation

Discover how you can navigate your implementation journey with effective strategies by viewing our latest Gold Standard QMS Whitepaper

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Where do you Need our Help?

For GMP Auditing, Quality Assurance & Digitalisation, we’re the partner of choice for all the stakeholders we deal with.

We provide extensive GMP consulting services to help keep our clients ahead of the needs and expectations of regulators.

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Global Audit Library

Explore our extensive GMP audit library to see the range and scope of live reports we have in stock, join a live audit, or commission a bespoke audit

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GMP Audit Services

Maintain high standards of life sciences manufacturing supplier qualifications and GMP auditing within the supply chain through our expertise

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GxP Consultancy

Discover how we can help your product reach to market, fully and demonstrably complying with the latest GxP standards

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Digitalisation

From data integrity to implementing new systems, our experienced team with a digital mindset, can lead you to transformative achievements

Let's get in touch

Please get in touch. Our expert GMP audit team is only a click away, on standby to answer all your questions.
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