Both FDA regulations and ISO quality standards require companies to establish a system for document control that is electronic in order to ensure product quality and safety.
An SOP entails a list of instructions that demonstrate how a certain process or procedure is carried out by the company. Usually, an SOP details on the recurring operations of a company. These can be related to technical, fundamentally programmatic or analytical aspects of manufacturing, maintaining or using the product. How do you unify the writing method for these procedures and ensure that these are being adhered to? The answer lies in these simple words - MasterControl's document control SOP software; that is all about bringing order in the way you document the procedures in the system.
Select all the resources you’re interested in downloading
As already mentioned, an SOP lists the steps acted out by a person to perform a certain set of operations. Now imagine how difficult it would be to manufacture a product without the help of SOPs. Products are not made by chance. Every single step of manufacturing is closely documented so that it can later be emulated without any error. Thus, you can safely term an SOP as a guideline that you adhere to in performing an action. Without properly written SOPs, you are as good as a blind man driving a car on highway. An SOP helps you see a procedure through in the correct order. So, it is extremely beneficial for the company's success to have accurately written SOPs in the system. MasterControl's document control SOP software is all about helping you manage current SOPs while ensuring that everyone is working off and trained on the most up-to-date SOP. This way you are always assured of documentation that correctly reflects the procedures. Thus, document control SOP software is all about doing business the right way.
Usually, document control SOPs are drafted in standard formats. As a general norm, SOPs are instruction-based written in a concise easy-to-read format. The main intent is to guide the readers through a task, which is why the instructions must be short and simple. In a complicated procedure, the writer can also use a flowchart or an illustration to demonstrate an idea. MasterControl's document control SOP solution provides the leverage of encompassing different types of SOP writing. Moreover, the software also helps in delineating ideas in the simplest form. This helps the intended audience to make most of the instructions and be able to complete the procedure without any difficulty.
Document control SOPs often consist of sensitive business operations that are emulated by employees across an organization. Therefore it is beneficial for you to ensure that the documents are written and managed correctly. This requires several rounds of reviews before the SOPs are signed off for approval. MasterControl's document control SOP solution helps you manage these documents by routing them to the concerned departments for collaboration and review. Any necessary changes and updates are made before the documents are electronically signed off and stored at a centralized repository. Once the documents are approved, they are considered as the official word for the related procedures. It is up to management to see to it that employees are trained and adhere to the SOPs throughout the organization. In case of any change or necessary corrective action, the SOP can be revised to make the necessary changes. During the time an SOP is checked out, the document cannot be modified by other employees. This feature ensures the integrity of the documents.
As a general practice, each document is numbered for identification and labeling purposes. This also helps in keeping track of the documents in the Quality Management System. The MasterControl document control SOP solution helps in keeping a specific ID number and a short title for each document. Moreover, each document has a version number that is updated along with any change in the document. The name of the user is also appended at the time of updating the document. The software is extensively developed to even help in figuring out what changes are exactly made to the document. All these factors help in establishing and giving a firm audit trail tracking to anyone who wants to track the document control SOP's change history and its preceding versions in the system.
Listed are some of the additional benefits of using the MasterControl Document Control SOP solution:
For additional details about the document control SOP from MasterControl, please contact a MasterControl representative for more detailed overview.