• careers

  • careers

Blog

No, Code 128 linear symbols may be used, but it leads to a very long barcode and such long barcodes may not fit on the labels of human cells, tissues, and cellular tissue-based products (HTC/Ps). The recommendation is to use 2D, especially in a case where a system is just being set up because it is more efficient.

Another consideration is what will be best for those receiving the product with the label. Those receiving the product must be able to understand and utilize the data included in a way that is useful to them.

USDM Life Sciences will help you assess, plan and execute the changes and enhancements necessary to meet UDI regulations. Our team of UDI experts will assess your products, the markets where they are sold and determine an implementation strategy for the changes that need to be made. USDM's assessment methodology is extensive and includes the labels and packaging, the management of identification changes to each product, the changes to PLM, ERP, EPCIS and packaging systems, changes to printing, vision inspection and warehouse/inventory management systems and interfaces to the GUDID.

Yes, technologies have started adapting to automatic IDs and capabilities associated with tissue storage and blood banking. The Eye Bank Association of America has just mandated ISBT 128 for international distribution of products for their accredited facilities beginning in 2017. For many reasons, software development companies are starting to become interested in ISBT 128 and a tracking system that can be built around it. In regards to blood banking systems, there are issues because the FDA 510(k) clearance for blood bank software does not include other uses. Software developers need to use the same principles, but many need to create separate systems for tissue and cells.

USDM Life Sciences will help you assess, plan and execute the changes and enhancements necessary to meet UDI regulations. Our team of UDI experts will assess your products, the markets where they are sold and determine an implementation strategy for the changes that need to be made. USDM’s assessment methodology is extensive and includes the labels and packaging, the management of identification changes to each product, the changes to PLM, ERP, EPCIS and packaging systems, changes to printing, vision inspection and warehouse/inventory management systems and interfaces to the GUDID.

Labels for HCT/P that are regulated as devices must meet labeling requirements for both biologics and medical devices.

This information about which HCT/P products are regulated as devices can be found on the FDA website.

FDA has defined which HCT/P products are regulated as medical devices. It is also possible to contact FDA directly. If it is not clear from pre-market documentation whether a product is regulated as a device or biologic or you have questions, contact the Center for Devices and Radiological Health or the Center for Biologics Evaluation and Research or the Office of Combination Products.

USDM Life Sciences will help you assess, plan and execute the changes and enhancements necessary to meet UDI regulations. Our team of UDI experts will assess your products, the markets where they are sold and determine an implementation strategy for the changes that need to be made. USDM’s assessment methodology is extensive and includes the labels and packaging, the management of identification changes to each product, the changes to PLM, ERP, EPCIS and packaging systems, changes to printing, vision inspection and warehouse/inventory management systems and interfaces to the GUDID.

1. The Cloud is Compliant

It is now possible and prevalent in the Life Sciences community to utilize cloud systems and processes to perform the complex and regulated (including 21CFR Part 11) business cases inherent to the industry, including but not limited to:

• Drug manufacturing and distribution
• Sample Management
• Document Management
• Quality Control
• Field servicing of medical devices
• Patient adverse event reporting and dispositioning

2. Saves Your Business Money (Reduces Cost of Ownership)

Moving your business to the Cloud lowers multiple costs including: IT costs, payroll costs, and capital costs (i.e. no infrastructure and minimal administration). You also pay only for “what you need” and can add users and functionality as your organization grows.

3. Security and Recovery

The Cloud secures large amounts of data to ensure the safety and privacy of your business. The cloud also allows for disaster recovery and rescue. Leading cloud vendors operate and maintain world-class data centers that are subject to continuous audits and regulations. The security and disaster recovery equipment and processes within these data centers is monitored 24x7 by teams of security experts to make sure your applications and data are always available with minimal downtime.

4. Automated Self-Service and Always Up to Date

IT help and service is minimized as the Cloud is regulated with automatic updates that are rigorously tested and documented under formal change control that can then be tested according to risk by end users, prior to production release.

5. Work from Anywhere

The Cloud can be accessed from anywhere, not just your home office or through a VPN. Cloud applications are also “mobile friendly,” delivering real time synchronized data availability and functionality in the field.

6. Scalability and Agility

The Cloud accommodates varying sizes of data sets and is often the only way to cope with the extreme amounts of data delivered from new technology. It is also easily scalable in terms of user base to enable adoption at the smallest level through to multinational complex use cases. Additional and specific configuration of applications is easily accomplished and allows for agile expansion and adoption.

7. Integration

Cloud applications are built on open platforms which allow for easier integration with other systems. Almost all cloud vendors offer APIs or connectors to their applications so multiple applications can seamlessly share data and processes.

8. Speed

The Cloud allows business services and applications to be implemented and configured in less time and with greater efficiency – taking advantage of the common “Core Platform” and supplier activities around compliance and implementation.

9. Best Practice Business Processes

Cloud systems are based upon extensive and specialist business use cases that have been developed over time to incorporate the needs of Life Sciences companies. This has led to the use of best practice techniques – inherent and built in to the software. Cloud applications are the most up-to-date versions of software. They provide the functionality necessary to drive best practices in the Life Sciences industry.

10. Efficient Collaboration

Shared files and documents held in the Cloud allow for easier backup, storage, version control, and collaboration.

USDM Life Sciences specializes in providing answers and solutions for life sciences companies looking to move their software and servers to the Cloud. In fact, many of the largest software and hardware companies in the world come to USDM Life Sciences for best practices in the Cloud.  As a recognized global leader in life sciences compliance, USDM Life Sciences’ cloud solutions provide security, lower costs and ensure compliance.

 

  1. SDLC & implementing quality engineering practices exist only in informal work practices; not documented in formal procedures
  2. No formal definition of SDLC phases, deliverables by phase, phase gate reviews, etc
  3. Lack of defined coding standards
  4. Process for code reviews, frequency of reviews, criteria used and method of documenting code reviews not adequately defined
  5. Backup process utilizes automated tools/utilities and lacks regular review of backup logs to identify failed backups or skipped files. No investigation or escalation of failed backups
  6. No regular testing of restoration process to ensure that files can be restored from backup, if and when, needed
  7. Utilities/tools used for bug tracking do not include objective evidence/traceability of test history including initial test failure, to bug ID, to fix/remediation, to retest case and final test results
  8. Test cases do not include recording of actual results and evidence of comparison with expected results for pass/fail determination
  9. Lack of defined preventive maintenance program for critical data center utilities including fire detection/suppression, HVAC system and emergency diesel generators
  10. Lack of annual review, update and simulation exercises/testing of Disaster Recovery/Business Continuity Plan

 

About the Author:
Robert (Bob) Lesnefsky is the Global Vice President of Quality Assurance and Regulatory Compliance and Auditing at USDM Life Sciences. He is a seasoned quality assurance and regulatory compliance professional with 30+ years of experience in quality assurance and regulatory compliance in the pharmaceutical, biotechnology, medical device, nuclear and petrochemical industries. Bob is sought out as the GMP/DEA compliance expert in providing compliance opinions and interpretations of cGMP to manufacturing, operations, quality and client services to ensure compliant drug product manufacturing operations.

USDM Life Sciences has a combination of over 100 years in regulatory compliance, Quality Assurance, Quality Systems and auditing. USDM’s auditors in the Global Audits Practice Team perform audits on Pharmaceutical, Biotech and Medical Device companies in the US and abroad.

Some of the options manufacturers are looking at to identify and support traceability of non-sterile implants are:

  1. Individually labeled sterile implants
  2. UDI tag – remains on the individual implant until use
  3. Direct Part Marking (DPM) – 2D barcode etched on implant
  4. Inventory control sheets – use sheets to map and recording sheets contain the DI in barcode and human readable lot number may be directly marked on implant (can be recorded or photographed)
  5. Mobile application – to support field replenishment – ties specific implant’s UDI to each tray/caddy and guides replenish activities

 

Typically, one solution will not work for a manufacturer’s entire product portfolio. Decision makers need to look at each product line and decide on the best solution for each type of device.

FDA does not require updates to CVs. Initial submission of documentation of training and experience on a CV is adequate. However, a sponsor may require CV updates. USDM Life Sciences recommends you adhere to sponsor requirements that are provided during the trial.

USDM Life Sciences has a combination of over 100 years in regulatory compliance, Quality Assurance, Quality Systems and auditing. USDM’s auditors in the Global Audits Practice Team perform audits on Pharmaceutical, Biotech and Medical Device companies in the US and abroad.

The Unique Device Identification (UDI) extension for some implantable devices only applies to devices distributed that are intended to be taken out of their package and sterilized before use, for example sets, trays and caddies.  Implants that remain in their sterile packing (class II and II) until use still have their original compliance deadlines.

USDM Life Sciences will help you assess, plan and execute the changes and enhancements necessary to meet UDI regulations. Our team of UDI experts will assess your products, the markets where they are sold and determine an implementation strategy for the changes that need to be made. USDM’s assessment methodology is extensive and includes the labels and packaging, the management of identification changes to each product, the changes to PLM, ERP, EPCIS and packaging systems, changes to printing, vision inspection and warehouse/inventory management systems and interfaces to the GUDID.

For clinical investigations of medical devices, an FDA 1572 is not required.  However, an investigator agreement is required for clinical investigation of medical devices.  An investigator agreement is not a specific form, it’s an agreement of the PI to conduct the trial according to regulations.

USDM Life Sciences has a combination of over 100 years in regulatory compliance, Quality Assurance, Quality Systems and auditing. USDM’s auditors in the Global Audits Practice Team perform audits on Pharmaceutical, Biotech and Medical Device companies in the US and abroad.

The extension for some implantable devices does not apply to all class II (FDASIA) medical devices.  The extension only applies to devices that are classified as FDASIA implants and distributed non-sterile.  It’s a limited subset of all FDASIA devices that have been granted this label extension to 2016.

USDM Life Sciences will help you assess, plan and execute the changes and enhancements necessary to meet UDI regulations. Our team of UDI experts will assess your products, the markets where they are sold and determine an implementation strategy for the changes that need to be made. USDM’s assessment methodology is extensive and includes the labels and packaging, the management of identification changes to each product, the changes to PLM, ERP, EPCIS and packaging systems, changes to printing, vision inspection and warehouse/inventory management systems and interfaces to the GUDID.

Testimonials

  • Clintrak - Jeffrey D. Coffin
    I have had the great pleasure to work with Bob for 5 years in his position of VP of Quality at Fisher Packaging Services while I acted as Director of Quality services at a sister…
See all Testimonials