Document Control Standards and the FDA
The Food and Drug Administration has precariously crafted certain laws and regulations that companies must follow before they are approved to launch a product to the market. There are many clauses under FDA regulations that are applicable for respective businesses, including document control standards. However, the majority of these regulations emphasize Good Manufacturing Practices, ensuring that the processes followed and products made must be of some particular standard. Because most of the companies are dealing in businesses that are life sensitive such as developing new drugs, aeronautical engineering, research of new medicines and ways of bettering human life; it is of primary importance to ensure that these companies are following correct practices. Any slippage can cause harm and endanger human lives. This is why the FDA monitors companies across the country. FDA has in its discretion to warn a company in case the company is not adhering to manufacturing laws. If the company continues, it can be stripped of its license to manufacture and in certain cases even be shut down.
As each process entails large amounts of paperwork, it gets tedious for companies to follow current document control standards. This gets even harder when updates to existing documentation are made. The problems are further increased if there is routing of a document from one department to another. A single miscommunication can lead to irreparable loss of time, resources and repute of the company.
How do you ensure that your company does not face these consequences? The answer lies in MasterControl's document control software.
MasterControl's document control software is meticulously crafted to aide companies in carrying out hassle free management of documentation that correctly reflects the standards and procedures in the system. FDA 21 CFR Part 11 emphasizes the required features of an electronic quality management system. MasterControl's document control solution provides you the features to comply with Part 11 and makes your life easier with dynamic archiving, version control and electronic signatures. All these features within MasterControl's document control software helps you maintain a secure centralized repository of documents that adheres to FDA regulations.
Document Control Standards in ISO Guidelines
International Organization for Standardization, popularly known as ISO, has devised a set of quality standards that companies voluntarily adhere to. Although it is not a compulsion to be an ISO certified company, usually companies prefer to be ISO certified as it is considered a global standard that helps companies in gaining the necessary edge amongst its competitors. ISO 9001 is the most popular standard which is particularly applicable to all kinds of organizations. ISO emphasizes quality management, document control standards, customer and regulatory requirements for any company. All these factors are essential for the organization to expand in growth and business. MasterControl's document control software is carefully designed to help your company become ISO certified. Our document control solution is laid out as a web-based repository in which users' access and control documents through an online portal system. The software ensures that only one user is able to check out and make the updates to a document at any time so that there are not multiple versions of the same document available in the system. The tracking of changes helps in verifying the updates made to the document as well as the user who has made the changes. All these features help in ensuring the integrity of the document is maintained. With MasterControl's document control solution, you can be assured of a secure system where only the legitimate users are granted access of the respective documents, making it easier to maintain your document control standards.
ISO certification also demands documentation on the training of employees, control of non-conformity, management review of processes, analysis and reporting. All these features are available in the MasterControl document control software where employees are provided with any document control standards and any other SOP documented in the system. In case an instance of non-conformance occurs in the system, you can launch a CAPA (Corrective Action, Preventive Action) to help rid the non-conformity. Moreover, the extensive management review feature helps in validating any process change before the document is electronically signed and checked-in for use. The analysis and reporting tools aid in studying various internal processes and formulating the necessary adjustments in how business is run in the company.
Additional Document Control Standards
If your company is planning to launch product in Canada, you also have to adhere to Canadian Quality Assurance and Control Standards. These standards help in keeping a check on food and health products, medicines, medical devices, blood, biologics, and other related products before they enter the Canadian market. In short, the main aim of these standards is to help businesses grow in a positive direction under certain rules and regulations. Controlling document control standards is all about helping you develop standard documentation that reflects the operations and procedures carried out in your business.
Learn More About Document Control Standards
For additional details about the document control standards from MasterControl, please contact a MasterControl representative for more detailed overview.