Management of process changes or design changes are critical to ensuring that you maintain the validated state of your product. DLS has experience with designing and implementing change management systems in Trackwise and SAP, reviewing and approving change orders, evaluating validation needs based on the requested change, and updating the appropriate documentation to reflect the changes.
Purchasing controls and evaluating supplier competency are essential elements of any quality system. Poor supplier management can result in out of spec products and can adversely impact patients. DLS can assist with supplier auditing, evaluation, tracking, and SCARs while helping you to maintain productive and effective working relationships.
Things don’t always go as planned. People make mistakes. Sometimes, things happen that are out of your control. Identifying, containing, and correcting problems quickly can help keep your business running smoothly. DLS will work to identify root cause, conduct thorough investigations, and determine the appropriate corrective and preventative actions.
Corrective and preventative actions are your organization’s defense system. They prevent deviations from becoming systemic problems. DLS can help you by establishing or helping to maintain CAPA review boards, processing or reviewing CAPAs, and by identifying and implementing the proper solutions.
Not only is it advantageous to take customer feedback seriously, it is also required. Effective complaint handling will result in less deviations, better throughput, superior products, and happier patients. Complaint tracking, trending, investigating, and reviewing are all areas that DLS can support in your organization’s quest to developing and maintaining an effective feedback system.
“If it wasn’t documented, it didn’t happen.” This is why document control systems are so important. As we enter into a more digital age, paper systems are being replaced with complex software that requires appropriate design, controls, and validation. DLS can bolster your documentation by assisting in selecting a new system, establishing proper review and approval workflows, and creating templates.
The design process has a number of checks and balances to ensure that the resulting product is what the customer wanted and what the manufacturer intended. Whether it is traceability of design inputs and outputs, design reviews, product testing, or DHFs, DLS will partner with you to make your design production-ready.
Unique Device Identifier (UDI)
The FDA’s new UDI rule comes with a unique set of challenges for medical device manufacturers. This is especially true for very small products or non-sterile products. DLS offers subject matter expertise related to labeling, barcodes, verification, direct part marking, validation, training, impact assessments, and other UDI needs.
Auditing/ Inspection Readiness
Internal auditing and inspection readiness prevent you from being caught by surprise. DLS can act as an independent reviewer for conducting mock audits, internal audits, or supplier audits so your organization is always prepared and ready.
Evaluation of patient risk and business risk are at the heart of most business decisions. Ensuring that your organization has an effective risk management program will allow those decisions to be made quickly – with little business impact. DLS can help improve or maintain your DFMEAs, PFMEAs, and other risk management documentation.
Do you have a new organization? Are you launching a new validation project? Is your company behind your UDI deadline? Does your group need a refresher? If so, you may need someone to help communicate internal or external expectations. DLS tries to make training easy, impactful, and affordable by offering onsite or virtual options.