Many of us are well aware of the advantages of using Product Data Management software like SOLIDWORKS Enterprise PDM. ‘In the case of Enterprise PDM, it’s more than just a server that provides a centralized location to store files. ‘It also maintains CAD files references for drawing and assembly files and additionally gives you the ability to create references for non-CAD files. ‘ By far, one of the biggest advantages of Enterprise PDM is that it keeps track of versions and revisions of all files making it very easy to review a product’s life-cycle.’
As a Medical Device Manufacturer, what would make you choose Enterprise PDM over another Product Data Management software when you know the others have the same functionality mentioned above? ‘Enterprise PDM goes beyond this common functionality and provides other advanced capabilities which are beneficial to Medical Device Manufacturers. ‘The United States FDA 21 CFR Part11 rule is definitely a major concern for companies in the medical field. This regulatory requirement requires that a company manages all FDA-related documents electronically, has the ability to get quick access to standard operating procedures, can quickly respond to on-demand compliance/reporting requests, adheres to electronic signature requirements, and can maintain the control of file versions and revisions. ‘SOLIDWORKS Enterprise PDM is designed and developed to help these types of companies comply with these specific guidelines and requirements.
As mentioned, one important requirement of 21 CFR Part11 is record management, a significant benefit of Enterprise PDM. ‘This capability significantly reduces the risk, time, and effort associated with adhering to these FDA regulations. ‘Every design change along with the review and approval events throughout the product development process are electronically recorded, providing a fully accountable audit trail. ‘Enterprise PDM does this by including a simple, flexible, and powerful workflow capability that allows each company to model their processes in a simple, state-based lifecycle model. ‘This approach to managing your New Product Introduction and Engineering Change processes ensures that you can quickly build an auditable source for authorized approvals at each required step/state in a document’s lifecycle. ‘Access to documents is determined by their state in the process, ensuring that documents are changed or viewed by the right people at the right time.
In compliance with the electronic signature requirements of 21 CFR Part 11, Enterprise PDM allows the application administrator to require users to provide their username and password to access the system and a second password (double electronic signature) upon promoting a document from one state to the next. This electronic signature is forever coupled to the document, providing the required authenticated approval information essential for an audit. ‘Enterprise PDM is also easily integrated with Microsoft’ Active Directory or LDAP directory service. This leverages the many authentication features (such as password aging and denial of service) provided by these services, eliminating the confusion and administrative cost of maintaining redundant security models.
Conducting an audit is efficient and accurate when using Enterprise PDM. All document records are categorized and assigned a set of additional properties, allowing for quick finding and immediate viewing of documents of interest. ‘If desired, the retrieved documents can be printed directly from the client without the need for the authoring application to reside on your local workstation. In addition, upon retrieval of a specific document, its audit history is only one click away.
There are many other advantages of using Enterprise PDM. ‘In addition to the tight integration with SOLIDWORKS and other CAD applications, Enterprise PDM is capable of storing, processing, distributing, viewing, and printing files in over 300 formats, including email messages, Office documents, PDF files, and graphics images such as TIF, GIF, JPG ,and more. This makes Enterprise PDM a sensible choice as the system of record for any other engineering or design related files.
Additionally, Enterprise PDM has low training requirements because it uses the native Explorer-based interface. ‘This provides every user with a familiar Windows’ look-and-feel, removing the user adoption barrier introduced by more complex enterprise applications. Users can simply store their Office documents to the secure Enterprise PDM Vault directly from the native menus of their favorite applications.
In summary, SOLIDWORKS Enterprise PDM can help companies in the medical field comply with the guidelines and regulatory requirements of the FDA’s 21 CFR Part 11 rule by increasing operational efficiency, ensuring regulations are met, and generating the information needed to demonstrate compliance.