What is a Regulated Environment
A regulated environment is basically any controlled environment. Rules state which conditions must be met by a company to produce valid results or goods of a guaranteed level of quality.
In other words, to comply with any regulated environment means to ensure that any operation with the data can be later reproduced. Clarity regards the following types of documents as data: chromatograms (*.prm), calibrations (*.cal) and sequences (*.seq). Thus, in Clarity, these files include their own audit trail log and, moreover, the chromatogram files are saved with their history.
The regulations set for the working environment may come from several sources, for example the company itself, government agencies and institutions (like the American FDA) or regulatory bodies and other groups with an interest in ensuring product standardization. When a company is to produce results or goods for the public which are going to be generally credible or of guaranteed quality, it should abide by the rules set on such processes by the given country’s authorities.
This manual was established to help the users of Clarity software to achieve compliance with those rules, which are issued for selected type of regulated environment.
Good Laboratory Practice
Good Laboratory Practice (GLP) embodies a set of principles defined by OECD and implemented by national authorities that provides a framework within which laboratory studies are planned, performed, monitored, recorded, reported and archived. These studies are undertaken to generate data by which the hazards and risks to users, consumers and third parties or the environment, can be assessed for pharmaceuticals (only preclinical studies), agrochemicals, cosmetics, food additives, feed additives and contaminants, novel foods, biocides, detergents, etc. GLP helps assure regulatory authorities that the data submitted are a true reflection of the results obtained during the study and can therefore be relied on when making risk or safety assessments.
CFR 21 Part 11
CFR 21 Part 11 is the directive issued by the United States of America Federal Drug Administration agency (FDA). It specifies conditions which must be met when an organization intends to submit or store documents required by the FDA in the form of electronic records, instead in the traditional paper form. The major concerns of this code are related to the nature of electronic records, with respect to their reliability compared to paper form documents.
The major issues are:
- System Validation
- Access to the records limited to authorized personnel only
- Documentation (Audit trail) of all modifications of the records
- Electronic signatures
A compliance with the directive can be achieved only by combination of the respective software capabilities, overall system settings and use of standard operational procedures as defined by the organization.