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Digital quality management is the digitized process that ensures products meet quality standards and are fit for their intended purpose. An ECM system can be used for digital quality management.
From document control to technical documentation to incident management—an ECM system has a wide range of applications in digital quality management and offers companies many benefits.
ECM software can not only serve as the central information platform for quality management documents, but it can also initiate and control the relevant workflows. It always provides the necessary overview.
No company can do without effective quality assurance. In some industries, however, business processes are monitored particularly strictly in accordance with quality guidelines. Companies must meticulously document virtually all of their activities. In the manufacturing of pharmaceuticals or food products, for example, quality management is intended to ensure that the products meet the exact quality standards specified at the time of their approval. At the heart of quality management are documents that detail business processes and are compiled into a quality management manual. Working with such documents and workflows can be significantly simplified with an ECM system.
On average, companies in regulated industries have between 800 and 1,500 active quality-related documents (QM documents), depending on the nature and scope of their business. Many of these must be reviewed regularly—usually annually—to ensure they are up to date. About 20 percent must be revised within a year due to changes in business processes and structures. This means that companies process between 400 and 700 quality-related documents per year. In addition to these documents, there are also those for “new releases”—that is, QM documents for processes that need to be redefined.
Processing QM documents is time-consuming because all changes and new releases must first go through a review and approval process. Afterward, they must be communicated to users and often even explained in detail during a briefing or training session. Acknowledgments and participant lists must be logged. The processing of QM documents must then also be logged across different version statuses. Other factors do not make the work any easier: linked documents and attachments, related documents, controlled printing, different language versions, and training management—to name just a few areas. This is where digital quality management can help ensure that you don’t lose track of everything.
The manual management of Standard Operating Procedures (SOPs) and their accompanying documents (source files, correspondence, manufacturing instructions, test and change logs, etc.) poses significant challenges for companies’ quality management departments. With ECM software, it is possible to implement a digital quality management system that is more efficient than manual management.
However, a digital QM manual is not just about replacing a file server system. The metadata associated with the documents must also be managed efficiently. Monitoring deadlines and validity periods, as well as ensuring the availability of documents, is increasingly tying up human resources. The workflow functionality in ECM software makes it possible to control process flows, better monitor deadlines, and automatically escalate missed deadlines. Furthermore, a simple electronic signature eliminates the need for signatures on paper documents. The user “signs” off on approval in the workflow process by re-entering their Windows login and password. The workflow process always displays the current “status” of the document or process.
Many companies today manage numerous QM documents on their file servers. A comprehensive Excel spreadsheet is usually used to manage versions and change history. This spreadsheet contains the metadata for all documents, and often includes the file’s “location” on the file servers. These are already good prerequisites for transferring the documents into an ECM system. The Excel spreadsheet serves as a control table; the metadata is extracted and imported into the database’s index data. The corresponding files are located on the file server and stored under the appropriate index entries. If only Word files are imported, the corresponding PDF file can also be automatically generated during the migration process. All documents are full-text indexed. This makes the documents available for searching within a predefined structure derived from the metadata. However, it’s important to note that these documents have not yet been validated. It would also be advisable to archive paper documents with signatures. These can be scanned and stored alongside the digital documents. This allows for later verification that the “new” documents match the originals. However, no matter how well the migration is prepared, there will ultimately be a residual portion of approximately 10% of all documents that cannot be fully migrated. These must then be processed manually. Once this is complete, however, a fully functional digital QM manual will be available.
Within the framework of quality management, all tasks begin with an “incident.” All quality-related incidents that occur within the company must be recorded, analyzed, and evaluated. As a result of this process, various actions arise, such as change requests, SOP adjustments, or regulatory filings. Incidents in this context have implications for quality control and audits.
The resolution of a nonconformity and the execution of a CAPA process can be handled seamlessly one after the other using the ECM system. All measures taken are documented. The entire process is automatically monitored and logged, while deadline and escalation management are handled by automated workflows. There are areas where a quick response is required to prevent worse outcomes (e.g., production issues). Others tend to have a longer “lifespan” (change requests, improvements, etc.). But no matter how long the response time is, nothing must be overlooked. Different types of events have different procedures and sets of actions that must be carried out. Although events occur unexpectedly, up to 80% of incidents are recurring. This means that recurring sets of actions must be established, distributed, and carried out. During this process, a large volume of documents is generated: e.g., correspondence, meeting notes, photographs, minutes, and analyses. Those with an ECM-based QM system now have a clear advantage: In addition to logging workflow-based processes, ECM also allows all relevant documents to be managed within a shared context. As a result, documents do not have to be searched for in random Outlook folders or local hard drive directories; instead, they are centrally available. This creates a complete electronic record that documents everything in detail—from the occurrence of the event to its resolution. If the event requires the execution of a change request and/or the modification of an SOP, the information can be “transferred” from the ECM software to other applications. For example, the entire process of a change request can be handled, controlled, and monitored using the ECM system.
The use of solutions based on an ECM system offers clear advantages for managing QM documents and handling QM processes. However, there will be some hurdles to overcome when implementing an ECM system. Implementing ECM software initially requires significant changes within the company. Not every employee involved will immediately see the benefit of using ECM software, as they will need to adjust their usual work habits to get the most out of the system. Although things will become more transparent and straightforward, the transition from a paper-based to a digital system will initially require a greater amount of effort. Therefore, when selecting a suitable system, one should not focus solely on the ECM system’s performance. The supplier’s experience in handling implementation scenarios and migrating existing systems are also important decision-making criteria.
