Thursday, December 1, 2016

Do Low-Risk Items Require Validation?

USDM Life Sciences is not suggesting not to validate any of your low-risk requirements. The important aspect to remember is if your implementation processes are documented, sound, repeatable, and your vendor has evidence of all the testing that they've done, you may not need to test out of the box functionality items that are considered to be low risk.

If you have items that are not GxP or low-risk GxP, depending on its complexity and configuration, you may have some informal user acceptance testing. You can leverage your supplier’s testing to have confidence in certain areas of the system’s functionality. You know the system can add 2 + 2; therefore, writing new test scripts may not be necessary. You can call back on the supplier testing if need be.

The majority of minor low-risk user testing items are going to be part of end-to-end, formal PQ testing, or integration testing. You are going to capture the information during this part of the testing and can reference those items when needed. Essentially, it would be redundant to write a specific test focusing upon that particular requirement on its own.

The USDM Life Sciences Cloud Practice 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.

Are VAPs Targeted for Out of the Box Applications Built on Salesforce or Pre-Packaged Solutions Like Viva?

The USDM Validation Accelerator Pack (VAP) takes care of the core platform. Beyond that, specific configuration and customization will be related to your company and your own use cases and requirements. By creating new scripts as necessary or modifying existing ones, those requirements are added to the preexisting requirements in the VAP. Although it is not possible to anticipate a specific company’s requirements in a VAP, we do qualify that platform and add in the necessary pieces.

The USDM Life Sciences Cloud Assurance Validation Accelerator provides the components required to meet FDA regulatory requirements including 21 CFR Part 11. For more information visit:

http://usdm.com/validation-accelerator-packs/by-vendor/salesforce.html 

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 and Services provide security, lower costs and ensure compliance.

For Class II DPM That Are Due In 2018, Would The Labeling (Carton, Etc) Used For This Product Need To Be Compliant In 2016 Or Would It Be On The Same Timeline As DPM – 2018?

The labeling UDI requirements are independent of the DM requirements. Therefore all Class II items, whether DM is required or not, must have their labels compliant by Sep. 24, 2016. The DM 'label' is not required to be compliant until Sep. 24, 2018 to allow additional time for implementation.

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.

Tuesday, November 1, 2016

Do Internal Audits Focus on Agency Regulations and Compliance Items or Do They Focus on Other Things Too?

With internal audits you want to audit to particular regulations. If you are under International Organization for Standardization (ISO) or Good Manufacturing Practices (GMP) constraints you want to make sure you are touching on any regulatory or compliance issues that a costumer, the Food and Drug Administration (FDA), or any other international agency is going to look at. That being said, it is also very important to concentrate on other areas as well as it comes down to best practices. You should look at your controls in place for everything from training records to manufacturing plans to organization and how you manage inventory. Concentrate on the regulatory compliance but be sure to include every area in your internal audit. If there are other areas that you feel are non-compliant, it is still important to audit concentrating on those areas as a best practice.

Internal audits are extremely useful and can be a very effective management tool when done properly. Some companies don’t do them thinking that a customer audit is interchangeable with an internal audit. This is not the case because customer audits are focused on a particular process line or product. With an internal audit you need to cover your entire organization and process line.

We recommend and use the FDA Q 10 approach when you are doing audits of your key systems, lab system, quality system, or manufacturing system.  That’s the approach the FDA uses as well. The FDA Q 10 is the most effective approach for getting the maximum value out of your audit.

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.

Friday, October 21, 2016

What Can a Company Allow a Vendor to Perform, and What Must They Perform Themselves?

A lot of times, especially when developing high levels of controls, companies in the industry feel that they need to do testing themselves. More and more companies are outsourcing the testing.

The fact is, a trusted vendor can do the calibrations and qualifications. Very often, vendors are the ones that set specifications for qualifications, so they are the best people suited to test. Validation can be done by vendors or contractors.

Regardless of who does the work, the company itself is responsible for defending the work. The company is responsible for the pre-approval, review, and the final approval process. When it is all said and done, the company owns the information. Whether it is calibration, qualification, or validation, the company’s Quality Assurance team is responsible for making sure that work is acceptable no matter who executed it.

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.

Thursday, October 13, 2016

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

If it is a basic instrument, it is best to have it calibrated. It is important to have a set of requirements to say what calibration set test points and ranges are producing data that are considered valid, even if it's not going into a regulatory document or submission.

The same process is recommended with regards to qualification. It is best to have met manufacturer specifications before instrument installation. You should do some type of testing, make sure the software works and that it is installed properly; that would go for any basic laboratory equipment.

Lab Systems that are not validated nor regulated would not need extra documentation, but it is still a best practice to have requirements and testing around any software that was used in a lab for data security and data integrity 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.

Friday, September 23, 2016

Are Physician Offices and Clinics Considered Dispensers Under the DSCSA?

Physician offices and clinics are considered a trading partner under the Drug Supply Chain Security Act (DSCSA) if they procure medications.  The source of procurement is responsible for meeting the DSCSA.  There are some exceptions for the electronic requirement for a physician’s office.  However, the purchaser of the pharmaceuticals that the physician is dispensing is responsible for meeting the DSCSA requirements.

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.