Pharma & Biotech







Digital transformation of GxP processes, validation of computer systems and regulatory consulting

We have more than 20 years of experience and professionals specialized in solutions to optimize your GxP processes through the validation of computer systems and regulatory consulting. We specialize in the digital transformation GxP processes, ensuring regulatory compliance, improving the efficiency of the pharmaceutical and biotechnology sector.

Pharma & Biotech

Computer systems validation

We offer a comprehensive computerized systems validation service, both in project implementation, management and coordination, and in maintaining the validation status.


We validate all types of computerized systems: 

       ✓ Laboratory instruments
       ✓ ERPs
       ✓ LIMS
       ✓ MES
       ✓ Document managers
       ✓ SCADAs
       ✓ Serialization systems
       ✓ Clinical trial management systems (eTMF, CTMS, EDC,…)
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Qualification of equipment and facilities

We guarantee the correct operation and maintenance of your equipment, instruments and facilities. We help you resolve any deviations that are detected, maintain its proper functioning and comply with all regulatory requirements.


We qualify all types of equipment:
       ✓ Particle counters
       ✓ HVAC Systems
       ✓ Thermal equipment
       ✓ CIP/SIP cleaning systems
       ✓ Production equipment
       ✓ Analytical instruments


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IT Qualification

We offer the process to demonstrate that the IT infrastructure has been installed according to established specifications and that its operation is within the recommended limits when used according to its instructions.


There are two types of strategies:

       ✓ Horizontal Strategy: for medium and large IT infrastructures

       ✓ Vertical Strategy: for small IT infrastructures


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Audit and Consultancy GMP, GCP, GLP, GDP y GVP

Our team is expert in GxP audits and will allow you to support the quality and compliance of your regulated operations:

       ✓ In regulatory compliance (GMP, GDP, GLP, GCP, GVP)
       ✓ Supplier and internal audits
       ✓ From providers of technological services and Cloud operations
       ✓ Specific regulatory requirements (Data Integrity, Anexo 11, 21 CFR Part11,…)
       ✓ Clinical trials (GCP)


We support you through consulting services such as:

       ✓ Ensuring good practices

       ✓ Support in the development of Quality Systems

       ✓ GAPs assessments

       ✓ Support for Computer Systems Developers

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Data Integrity

Achieve homogenization and standardization in the application of data integrity principles (ALCOA+) through our specific methodology (DIRA). Ensure compliance with the main regulations (21 CFR Part 11, Annex 11 EU GMP).


We accompany you in the development of policies and procedures to maintain data integrity. In addition to:
       ✓ Identification of relevant records
       ✓ Identification of data and metadata

       ✓ Definition of data flows

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Our services


Digital Validation

Comprehensive validation management system, not only for the digitalization of the process, but also to ensure that good practices and data integrity controls are applied in all your processes.

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It is responsible for maintaining the validation status of different SaaS systems such as Tracelink, eCTD, Pharmacovigilance, Training, among others.

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We add value to your serialization processes and transform the management of your supply chain to jointly advance towards Pharma 4.0

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Service designed to drive digital automation, setting up automatic calculations in analytical methods for chromatographic systems.

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Our Pharma & Biotech Services

Within the Pharma & Biotech area, there are 4 new aspects that aim to respond to different market needs that exist today. What are we talking about?

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Our partners:

Dot Compliance