SALT LAKE CITY UT USA - May 24, 2006 - Companies use Standard Operating Procedures (SOPs) for a number of reasons, but for companies in the FDA and ISO environments, compliance is a major driving force. This white paper prepared by MasterControl discusses why SOPs are more than just a tool of operation. SOPs directly affect product quality, and therefore, compliance. Once established, an efficient and effective SOP management system will serve as a foundation for an organization's sustainable compliance and long-term success in the market. This white paper, titled "SOP Management as a Compliance Tool in FDA and ISO Environments," covers the following: --Types of SOPs and reasons why companies use them.
--Regulatory basis for establishing and maintaining SOPs (21 CFR Parts 211, 606, and 820; ISO 9001 and ISO 13485). --Common challenges in SOP management. --MasterControl solution.
About MasterControl
MasterControl Inc. has been at the forefront of providing innovative quality management software solutions since 1993. Hundreds of companies worldwide use the MasterControl solution to consistently meet FDA regulations, ISO standards, and other regulatory requirements. In addition to providing off-the-shelf products, MasterControl offers comprehensive technical and customer support, including product training, installation, implementation, and validation services.
