With the great supply of management software available along with the relatively low cost of deployment, many medical companies started to control everything via system, eliminating much of the printed documentation, bringing great benefits in the management of the company.
The counterpoint to such an approach is that, with the system storing critical data in terms of traceability of products and processes, and because of this, the whole system must undergo a validation process, where this validation must contemplate a detailed qualification of each point that impact directly on the product, such as: risk management system and documentation related to installation, staff training, version control and company’s requirements and how they were implemented.
To help companies carry out validation, there are several guides: ANVISA offers the “computer systems validation guide” for free; the FDA has 21 CRF Part11 dealing with the same subject; and the European Union has the GMP Annex 11.
In addition to the guides provided by regulatory agencies, ISPE (International Society of Pharmaceutical Engineering) produces a guide called GAMP 5 (Good Automated Manufacturing Practice) that addresses all global software validation requirements.
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Passarini Regulatory Affairs