A standard operating procedure (SOP) is a company’s documented method for its business processes. As such, it’s important to set up guidelines for those SOPs before they are written to ensure uniformity and that all legal and regulatory requirements are satisfied.
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Generally, U.S. Food and Drug Administration (FDA) SOP requirements are concerned with ensuring quality within a company. Using proper SOPs helps companies comply with FDA requirements, and the SOPs themselves are used by the FDA to assess whether companies are compliant. The SOPs needed by a company are partially determined by what industry that company operates in. For example, a pharma company will need different SOPs than a food manufacturing company.
Pharmaceutical companies have to operate under the strict regulations put forth by the FDA, or other regulatory bodies. That makes the pharma SOP guidelines stricter than they would be in other industries. One example is that pharma companies must have written SOPs showing that their products have the identity, strength, quality, and purity that the company claims.
The MasterControl Quality Excellence Solution™ functions as an SOP writing software for companies trying to create, improve, and organize their SOPs. With the templates provided by MasterControl, writing the initial SOP is comparatively easy. Managing and revising the SOPs after the fact is difficult. As a document control system, this solution keeps all SOPs in a centralized location and tracks revisions automatically.
Organizations all over the world use MasterControl software solutions to ensure compliance – including organizations that enforce compliance. The U.S. Food and Drug Administration (FDA) became a MasterControl customer in 2009. Since then, the FDA has expanded its use and now multiple divisions of the agency use MasterControl software solutions.