If a CRO is Managing My Clinical Trial Data, What are My Validation Responsibilities?

If you have a Contract Research Organization (CRO) that is managing and hosting your content and you're accessing their content management solution. The responsibility is on the CRO to have a validated compliance content management solution for your content. However, you have to do due diligence and close your vendor auditing practices, as well as your vendor management processes, and your SLA with your CRO to ensure that you've done proper due diligence to make sure that they are properly managing your content. The burden is effectively on the CRO, however you have to do your due diligence to ensure that you're auditing them appropriately out of their system validation materials, as well as making sure that the processes and procedures are up to par for managing content.

The USDM Life Sciences Clinical Services and Solutions team provides our clients (from start-up Biotech to large Pharma/Device) with the latest technology, processes and strategies to assist with efficiency, quality and compliance in any scenario and offers our clients a cost-effective, proactive and unified partnership in goal achievement.

What are the Costs, Elements, and Approximate Timeline to Implement a Compliant Field Service Solution?

It really depends on how many users you're looking at and some of the complexities with your environment and requirements. As far as line items, you're going to be looking at the field service application licensing. We have to get the application into our environment -- into the user's hands. How many people do we have? That is going to be one dollar amount.

Then you've got the implementation services. Those, you can imagine, vary quite a bit depending on, again, the size of your service organization and some of the various requirements that you have with your different field service processes. Those implementation services are also going to include the initial validation that we would perform. Again, it's all one professional service number. Then, you've got the subscription for the ongoing validation documentation that USDM provides with each seasonal release. Those are the ways we would just provide a high level breakout for the different costs involved.

As far as the timeline, what we're seeing out there is an average of 3 to 6 months to implement a validated field service application. Again, the timelines can go up or down based on a couple of things. Most often it's around data migration. How much data are we starting with? Do you have years and years of field service history that we need to bring in and make that available within ServiceMax. If yes, that's just going to take a little bit more time.

Also integration. ServiceMax is built on a platform which is extremely open, and it's not hard to tie in to other systems like your ERP, a complaint management system. But, it's just those things need to be thought about and brought into the project. You can, like I said, depending on the complexity, either lower that amount of time or extend it out a little bit.

The USDM Life Sciences Cloud Team is the one you can trust when looking to move applications and business processes to the Cloud. Our team of cloud experts understand compliance, validation, implementation, mobile, data security, data migration, and system integration, and we ensure that leading cloud vendors meet and maintain compliance regulations around the globe.

What is the Recommended Approach for Control on Non-Regulated Laboratory Instrumentation?

Michael Ambrose, Vice President of Lab Services and Solutions at USDM Life Sciences says his approach would be for a calibration or a qualification. For instance, if it's a basic instrument, he’d still want to calibrate it. He would still want to have a set of requirements to say what the calibrations test points and ranges should be and make sure that that system is producing data that I could consider valid, even if it's not going into a regulatory document or submission. The same with qualification. He would definitely have manufacturer's specifications being met before I installed an instrument and the analogy I use often is a librarian is going to want to get their books back if they're using a software to track it. They're going to want to do some type of testing, make sure the software works, make sure it's installed properly and that would go for any of the basic laboratory equipment. The place he would maybe change if it wasn't validated, if it wasn't regulated, would be a validated system.

Ambrose says he might not do the extent of extra documentation, but would certainly have requirements and testing around any software that was used in a lab just for data integrity and data security reasons.

USDM Life Sciences offers a complete suite of laboratory enterprise validation and compliance services led by a core team of highly qualified, scientifically trained laboratory instrument/systems specialists.

Unique Device Identification - A Hot Topic in Healthcare

Unique Device Identification (UDI) took center stage at this year’s AHRMM 15 Conference.  In the hallways and in sessions, including my panel session on the topic, hospitals, regulators, solution providers and suppliers discussed the obvious benefits of having consistent, accurate and unique identifiers for devices and pharmaceuticals to ensure better tracking throughout the healthcare supply chain to reduce counterfeiting, speed recalls and improve post-market surveillance. With the UDI regulation for devices, FDA’s implementation of the Drug Supply Chain Security Act (DSCSA ) and The Joint Commission tissue tracking all in full force this year, in addition to unique ID data capture requirements proposed under Meaningful Use (MU) Stage 3, many hospitals and suppliers are working hard to not only comply, but excel in this incredible time of technology and change. The industry is in the midst of transformation as it learns to harness and hone tremendous amounts of data to propel accuracy, safety and security in the nation’s healthcare system, while also meeting tight regulatory deadlines.

Those who incorporated the UDI into their information systems for last year’s Class 3 implant requirements are reaping the benefits of accurate, consistent product information.  Others still have to catch up. AHRMM attendees stated, for example, that they are not aware of all the UDI requirements, even the ones providers are responsible for, such as storage of the entire UDI, including production identifiers, for retrieval in adverse event reporting.  Proposed MU Stage 3 requirements for Electronic Health Records will provide the software enhancements to make this possible for implanted devices as well as document in registries and support value analysis.  The industry as a whole needs to be better informed on what's in the UDI regulation, who and which items are affected and when the deadlines are.  USDM Life Sciences will publish more details around this topic, including upcoming blogs about which products require UDI and how hospitals can use Master Data Management as a strategy to make sense of all their data.  In the meantime, you are not in this alone.

USDM Life Sciences offers healthcare a comprehensive assessment, strategy and solutions to implement end to end traceability of pharmaceutical and medical devices from point of receipt through to the electronic health record.

Top 10 Key Audit Failures

1. No annual review of Environmental Monitoring data and assessment of the continued appropriateness of current action and alert limits.
2. Environmental monitoring programs which do not establish investigations or actions for a number of alert limit excursions which occur during a discrete time period.
3. Supplier qualification processes which are based criticality of supplier on annual procurement $ spend rather than GxP criticality dimensions such as safety, quality, identity, purity or potency.
4. Supplier qualification processes which allow too long a time period between initial qualification audits and subsequent re-qualification audits.
5. Supplier qualification processes which do not take into account supplier performance history and the need for adjustments to defined audit frequencies.
6. Process qualification of critical quality attribute ranges which are not scientifically justified based upon DOE or other science based rationale.
7. Computer systems validation of key systems used to support quality or production systems which does not include a periodic review process following initial validation to evaluate the collective impact of change controls and the maintenance of the validated state of control.
8. Recall procedures which do not include provisions for a mock recall to verify lot genealogy/traceability.
9. IT back-up processes which utilize automated tools/utilities with no manual review of backup logs to verify that there were no failures or files skipped.  No process for investigation or escalation of backup failures to IT management.
10. Failure of cleaning validation to consider limit of detection, limit of quantification, various materials of construction and risk parameters such as worst-case model compound, solubility, number of difficult to clean areas and total product contact area.  

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.

What Would Happen if You Change Your Barcode Standard?

USDM Life Sciences has quite a bit of experience with this. Let’s say you chose to move to GS1 standards, you're effectively changing the label.  You would have to sunset, retire, and create a new record associated with the GS1 standard as your device identifier.

There are some ways to do this that are a bit more flex, if you haven't already submitted the record, that we've helped some clients with. So if you've already submitted, then you're going to have to end date and then create a new record. If you haven't submitted, then take advantage of the primary and secondary DIs that are associated with the product so that you don't have to create new records downstream.

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.

How are Healthcare Providers Managing their Pharmaceutical Data?

Generally, the information that's coming from the distributor is very well-managed by the distributor through to the hospitals, but using a solution is still a benefit. Where providers have more difficulty with keeping up with the documentation is for their orders that go direct to the smaller companies. That's where the magnitude comes up, but it's probably an 80/20. They order most of their product through a distributor, so it's covered, but they can order from up to 50 smaller manufacturers. They have to have a process in place with each individual manufacturer, and that is very cumbersome.

USDM Life Sciences offers healthcare a comprehensive assessment, strategy and solutions to implement end to end traceability of pharmaceutical and medical devices from point of receipt through to the electronic health record.