Asesoría y Validación

"A complete team that provides expert solutions"

ASYVAL

Consultancy firm specialised in providing validation services, technical support, assessment and project management resources to the pharmaceutical and related companies that must work under a GxP environment.

Quality
Offer a high quality service, imperative to the sectors we are working at.
Width
Provide the widest possible range of services, adapted to all kind of projects.
Flexibility
Work with the maximum flexibility, to adapt us to the customer's requirements.
Compliance
Ensure compliance with regulations in all projects.
Coordination
Coordination of installation and validation tasks with the involved firms.
Strategy
Possibility to establish a global validation strategy for the whole plant.
Compliance
Systems analysis to know their compliance level.
Update
Application of the latest tendencies in rules and guidelines to the regulated industry.
Rigorousness
Application of the latest tendencies to the validation process in the pharmaceutical industry.
Consistency
Consistency between technical and quality assurance criteria during the whole installation process.

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ASYVAL

ASYVAL was founded in 2003 by a team of technicians with different and complementary backgrounds. This allows you to obtain a global solution to your projects’ requirements.

We are a flexible firm that works providing the most suitable support to the customer depending on the specific needs of the moment, adapting to their requirements and those of their environment.

In July 2004 ASYVAL was awarded by the Regional Government (Diputació de Barcelona) a prize to the enterprise with the best quality management system. At present this quality management system is certified according to ISO 9001. We have proven experience, which has been the key point to let us actively participate in projects both at a national and international level.

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Services

To our team belong qualified and experienced personnel who offer you the best services of Quality Consultancy, Validation, Project Management and Training.

CONSULTANCY

  • Technical reports preparation
  • Internal Audits
  • Supplier Audits
  • User Requirements Specification
  • SOPs preparation
  • Advising to systems design
  • Change Control
  • Risks Assessment
  • Data Integrity
  • Serialisation

VALIDATION

  • Process Validation
  • Machines Qualification
  • Facilities Qualification
  • Computer Systems Validation
  • Control Systems Qualification
  • Cleaning Methods Validation
  • Analytical Methods Validation

MANAGEMENT

  • Coordination of the involved suppliers
  • Samples management to be used during acceptance and validation tests
  • Deadlines achievement
  • Advice to new suppliers
  • Project reports issue
  • Convene and lead project meetings

TRAINING

  • Validation Projects Management
  • Computer related Systems Validation
  • Machines Qualification
  • Facilities Qualification
  • Analytical methods Validation
  • Cleaning methods Validation
  • Production processes Validation
  • Serialisation solutions Validation
  • Data Integrity
  • Good Manufacturing Practices (GMP) for workers
  • Good Manufacturing Practices (GMP) for area responsibles
  • ICH guidelines
  • 21 CFR Part 820
  • 21 CFR Part 11
  • ISO norms
  • Suppliers official approval
  • Audits
  • Others

Sectors

ASYVAL works for the sectors that require compliance with the quality rules
  • Pharmacy
  • Chemistry
  • Medical Devices
  • Clinical Analysis
  • Hospitals
  • Cosmetics
  • Veterinary
  • Food Industry
  • Machine Manufacturers
  • Software Developers
  • Engineering
  • Training Centres

Solutions

ASYVAL adapts to the customer requirements, providing technical support at the required level by each project.

ASYVAL can work at different levels: partial or total participation in the project or representation of the customer against external suppliers.

We provide solutions in: definition of strategies and methodologies to achieve the objectives, supplier audits, technical advice, project management, validation protocols preparation and execution, SOPs preparation, training, external audits and supervision of designs, technical documents and validation documents.