One of the pillars of the knowledge management process is, “You don’t know what you don’t know.” When you’re in charge of the quality management system at a MedTech start-up, this is often the case. To put it simply, quality managers at MedTech start-ups can overcomplicate things because they try to do it all.
You want to do things the right way, and sometimes that can lead you to create an overly burdensome quality management system (QMS) that is so complicated, it’s bound to lead to mistakes, and result in being hard to keep up with as well as make it difficult to manage the data.
In an effort to simplify, you’ve considered trying an electronic quality management (eQMS) solution, but just don’t know if the benefits are worth the cost. Here are six solutions an eQMS provides for your medtech startup.
1. Document control
Document control can make or break your QMS. eQMS software was designed to eliminate the usual pain points of a document control system. Without an eQMS, paper-based document processes are heavily human dependent, error-prone, and ripe for audit observations.
Managing document approval and distribution becomes much easier when approval is completed and tracked electronically. Distribution is easy too, requiring only a workstation for employees to access the most current revision. eQMS implementation provides a single-source of truth for your documentation.
When changes are needed to the quality management system, electronic copies can be updated, changes seen via red-lines, and updated versions are available immediately. The assurance provided by eQMS software covers multiple systems and ensures compliance.
A key requirement of the FDA’s Quality System Regulation (QSR) is personnel. While it seems obvious that sufficiently trained employees are needed to ensure compliance with quality management system requirements, what is not obvious are the best ways to comply.
When breaking down the many working parts of a training system, it quickly becomes clear that job descriptions, training requirements, and training effectiveness are just the foundation. Scheduling and tracking training make up a large part of the Training Manager’s time. eQMS software implementation removes much of the burden by automatically tracking training requirements, completion and due dates.
Thought of as a necessary evil, audits are a fact of life in the MedTech industry. Instead of being a chore, audits can provide insight into potential problems. During an audit, finding the requested records can be time consuming, and cause an auditor to dig deeper into troublesome areas. Managing audit documentation can be simplified with eQMS software implementation because it provides immediate access to documents requested by the auditor.
On the flip side, when conducting internal audits, all of the necessary paperwork, audit schedules, audit plans, and audit reports can be stored in the eQMS software. Any required NCMRs or CAPAs can be linked electronically to audit findings.
4. Nonconforming product
Nonconforming product happens. As long as there is standard operating procedure to deal with errors as they occur, you’re meeting the requirements of a quality management system. But if you’ve spent any time in a manufacturing environment, you’ll quickly find that documentation is just half the battle.
Nonconformance documentation has to be written, reviewed, and approved. Usually the reviews and approvals go through several hands – engineering, operations, and quality. If a reviewer doesn’t agree with the write-up, edits are necessary. Think crumpled NCMR and trash can, and back to the drawing board. eQMS implementation can relieve much of that burden by electronically routing documents for review and approval.
Once approved, eQMS software can automatically close out the NCMR, allowing immediate disposition of the product instead of long waits in the warehouse.
5. Corrective and preventive action
Nonconformances go hand in hand with corrective and preventive actions. Quality management systems require determining the root cause of NCMRs, and then implementing corrective actions to fix. Preventive actions also need to be settled to keep the NCMR from happening again. The quality department must ensure the CAPAs work by reviewing their effectiveness.
Traditionally, NCMRs, CAPAs, and verification have been tracked through logbooks or spreadsheets. While there is nothing wrong with that approach, it is labor intensive and prone to errors. Utilizing eQMS software to manage CAPAs ensures a consistent approach and no missed due dates. It is also easier to trend and review problem areas.
6. Design controls
Design controls are an essential part of a MedTech quality management system. Linking user needs, requirements, verifications, and validations requires cross referencing in a traceability matrix. Engineers and other staff need access to documentation to ensure accurate traceability.
An eQMS software provides a portal where all design control efforts can be housed. Often, documents can be cross-referenced through electronic links in the eQMS software. This easy access ensures the most up-to-date references are used.
In the MedTech world, documentation is a critical element of the quality management system. For a MedTech startup, eQMS software can provide the framework on which the QMS is built. While it won’t prevent nonconformances, it can provide a consistent method to address them.
If the cost of eQMS implementation has prevented you from seriously exploring this option, realize that current eQMS solutions are available in many different configurations and price points. Often, the upfront cost of an eQMS software is offset in the savings realized from compliant documentation, ease of use, and avoided lost time.
Becky Blankenship is a technical writer at Cannon Quality Group. She has a background in quality management in the pharmaceutical and medical device industries. She has a bachelor’s degree in chemistry from the University of Southern Mississippi. Prior to joining CQG, she worked for more than a decade as an auditor and technical writer.