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Computer Systems Validation

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Quality Assurance and Compliance

 

GxP Quality Systems Our experience in the GxP Quality Assurance area is at our clients disposal for any kind of project; either is to write procedures, to define a materials or people flux, to establish a risk analysis associated to an installation or process or any other Quality topic, we will have the possibility of contribute with the necessary experience to solve the issue.
ISO 9000 Quality Systems Do you want to get, for your GXP Quality System, the ISO 9000 certification? SEV can help you with the integration between your Quality System and ther requirements pointed out in the ISO 9000 rule, supporting you in the definition of an action plan, the creation of a Quality Manual, the generation of the necessary procedures for the integration and the process to obtain the certification.
Audits GxP rules establish that is mandatory to execute periodical reviews of the Quality System, in order to assure its correct application. Internal audits form part of the obligations of every pharmaceutical company, so as the audits for the material and critical services providers. Not always, but it is possible to have the proper resources to audit an internal department of a provider. SEV counts on expert staff in te execution of GxP audits, both to raw material providers (APIs, excipients, primary packaging materials...) and services providers.

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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