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Computer Systems Validation
We can validate whichever type of Information System, spanning from Enterprise Resource Management systems (ERPs), to Laboratory Information Management Systems (LIMS), to complex (SCADA) or simple (PLC) control systems.
You can count on us for your computerized system validation projects.


Process and Equipment Validation
Process and equipment validation is crucial for the correct implementation and maintenance of GxP compliance.
Our consultants will provide you with the necessary expertise you need to validate and maintain in validated status your processes and equipments; we have a large experience from the simplest equipment to the most complex process. .


Quality Assurance and Compliance
We can assist you in implementing or expanding your Quality Management System; our consultants may advice you about international rules and standards, providing you with a complete support for every activity regarding Quality Assurance of your processes and products.


Systems Implementation Consultancy
An important service is aimed at the definition of the best strategy to follow in implementing new systems; our experience in this field is at your disposal in order to save time and resources in the implementation process of your new systems, equipment or facilities.


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Equipment used in the manufacture, processing, packing, or holding of a drug product shall be of appropriate design, adequate size, and suitably located to facilitate operations for its intended use and for its cleaning and maintenance.

21 CFR Part 211, Sec 211.63

Validation should be considered as part of the complete life cycle of a computer system. This cycle includes the stages of planning, specification, programming, testing, commissioning, documentation, operation, monitoring and modifying.

EU GMP, Annex 11, Computerized Systems

The manufacturer shall establish and implement an effective pharmaceutical quality assurance system, involving the active participation of the management and personnel of the different departments.

COMMISSION DIRECTIVE 2003/94/EC, Article 6

It is a requirement of GMP that manufacturers identify what validation work is needed to prove control of the critical aspects of their particular operations. Significant changes to the facilities, the equipment and the processes, which may affect the quality of the product, should be validated. A risk assessment approach should be used to determine the scope and extent of validation.

EU GMP, Annex 15, Qualification and validation