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Computer Systems Validation

Management systems

Laboratory Systems

Control Systems

Clinical Trials Management Systems

Process and Equipment Validation

Quality Assurance and Compliance

Systems Implementation Consultancy

Computer Systems Validation

 

Management systems Management systems are information systems that integrate some data and processes of an organization into a unique environment; normally production, financial, planning and distribution operations are covered by huge management systems. Among them, we can find several categories: - ERP: Enterprise Resource Planning - MES: Manufacturing Execution Systems - MRP: Manufacturing Resources Planning These systems usually produce, store or archive GXP-relevant data, and this is the reason why they shall be validated. SEV counts on experienced staff in the validation of the most widespread systems.
Laboratory Systems Over the last decade, the automation of both analysis and data collection operations has radically changed the way of working in the Quality Control laboratory; computer systems started to play a central role in complying with GxP rules. Analytical equipments control systems, such as for HPLCs, GCs or mass spectrophotometers, do not only perform analysis totally unattended, but generate and store raw data used for obtaining final results. In many cases, all of these data are centralized in laboratory information management systems (LIMS), capable of integrate the information from different analytical results for batch release. All of these data are GxP relevant, and this is the reason why these information systems need to be validated. SEV counts on experienced staff in the validation of the most widespread laboratory systems.
Control Systems Control systems have amazingly evolved during the past decades; it is now unthinkable the implementation of any equipment or production line without its associated automated control system. All of these systems manage functioning parameters affecting, in many cases, the quality of the final product. Access Control Systems and HVAC Control Systems fall in this category. According to the GxP rules, validation of these systems is mandatory. SEV counts on experienced staff in the validation of all types of control systems.
Clinical Trials Management Systems Clinical Trials Management Systems handle a huge amount of data which will be used to demonstrate the purity, efficacy and safety of a drug. The results obtained in clinical trials will be used in the approval process of new drugs. Security of processes for data input, storage, analysis and printing processes is essential. All of these systems, due to the central role they play in data integrity and accuracy, require validation. SEV counts on experienced staff in the validation of Clinical Trials Mangagement Systems.

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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