Computer Systems Validation

Over the past decades, the Life science industry has progressively introduced computer systems to support manufacturing, control and logistics processes. As a consequence, these became critical elements from the point of view of GxP regulations and, therefore, the Health Authorities have significantly increased their pressure on their role and on the data they manage.

As a result of this pressure, in regulatory inspections we can see an increasing number of observations related to computerized systems, with special relevance to those aspects related to Data Integrity. These observations can lead to serious problems with direct consequences on the business and corporate image.

In today’s competitive environment, reducing costs and increasing efficiency can be the key to a company’s survival. By adopting cloud-based systems, you can increase efficiency and prepare for future challenges with respect to data integrity and the expected amount of relevant data to be managed in the coming years.

Digital mindset: we rely on technological transformation to achieve “Good Manufacturing Practices” and advance in risk management and sustainability in the industry.


In this situation, the regulated industry is forced to increase the technical approach in the validation of its computerized systems, as well as its management practices, in order to meet expectations in regulatory inspections.

Rephine is a global consulting company that is recognized as a pioneer and leader in the validation of computerised systems. Rephine always carried out these activities according to high technical and quality standards, aware of the applicable regulations, current practices and the needs of each client. These values have allowed the generation of methodologies, criteria and state-of-the-art documentation over time, which has satisfied the most stringent requirements of the inspectors in multiple audits of health authorities and clients.

We have a team of international consultants with extensive knowledge of the technologies and computer systems used in the pharmaceutical industry. Sensitive to the flexibility required by our clients, we adopt the role that best suits each case: from “turnkey” projects where the client’s effort is minimized, to ad-hoc consulting. Always providing a collaborative environment, in order to generate internal knowledge to guide their current practices and future decisions.

Data Integrity compliance and action plans

Decommissioning of computerized system

Cloud Systems Validation

Quality Systems for IT departments and IT service suppliers

Quality Systems for software developers

Computer infrastructure qualification

Audits for IT solution suppliers


For further information, get in touch with our CSV Experts

Where do you Need our Help?

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

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

Browse Audit Library

GMP Audit Services

GxP Consultancy

GxP Consultancy

Global Audit Library

Global Audit Library



Related Resources


ValGenesis & Rephine Partner to Deliver Digital End-to-End Compliance Solutions for Life Sciences Companies

The strategic alliance will offer global pharmaceutical companies a streamlined, software-based solution to enhance quality assurance across their global supply chains San Francisco, February 28, …

Read More

EC Proposal Amending MDR & IVDR Transitional Provisions (2023)

EUROPEAN COMMISSION PROPOSAL AMENDING MDR & IVDR TRANSITIONAL PROVISIONS (2023) On February 16 2023, the European Parliament finally voted on the EU Commission Proposal about …

Read More
SQA PR Article 1 Article

Rephine to sponsor forthcoming Global Quality Assurance Conference

Specialist GMP auditors will provide three speakers at the event, focusing on Good Manufacturing Practice, Quality Management Digitization, and GMP & Quality Data Integrity.   …

Read More
shutterstock 793279159 Blog

New EU GMP Annex 1 requirements: EMA says no deadline extension

An appeal to the European health authority for leeway on the August 2023 compliance date has been rejected, putting the onus back on drug manufacturers …

Read More

Preparing to meet EU GMP Annex 1 requirements related to the Manufacture of Sterile Medicinal Products

Summary EU GMP Annex 1 requirements for Manufacture of Sterile Medicinal Products were revised in August 2022, starting the clock for compliance by August 2023. …

Read More

Pharma Manufacturing Transitions to Biotech and Personalized Therapies Drives Quality Process Innovation

Pharma Manufacturing Transitions to Biotech and Personalized Therapies Drives Quality Process Innovation Article by  Dr. Eduard Cayón, Rephine Published by Pharmaceutical Outsourcing The past decade …

Read More

The roaring 20s: what a time to be Life Sciences’ Quality backbone

Bringing rigour to global supply chains as the reinvention of medicine continues by: Dr. Eduard Cayon, VP Audit Services, Rephine New waves of innovation in …

Read More

Practical Steps to Compliance with EU GMP Annex 1

About this Ebook In August, the revised EU GMP Annex 1 requirements, related to the Manufacture of Sterile Medicinal Products, were issued, starting the clock for …

Read More

CPHI 2022 Golden Ticket

Read More

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.
Social: Linkedin


Rephine HQ, UK
+44 1763 853135

Barcelona, Spain                               +34 934 178065

    Rephine respects your privacy. Choosing to check the box means that you agree to the Rephine Privacy Policy. You can unsubscribe at any time.