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There are a number of GCP audit checklists, some of them are available for free online.  An Internet search for “GCP audit checklists” will provide you with many checklists to choose from.  The auditors at USDM Life Sciences recommend including a checklist as part of your quality assurance process – don’t wait until you get an audit notice to prepare.

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.

It’s important to be very clear in a Request for Proposal (RFP). If you want validation or training services, specify exactly what you are looking for in the request. For example, some companies have validation staff, but may not have a validation leader. You may want to specify that you only need a validation team leader. If you will need training services, include who will need to be trained. You may only need help training the trainers or you may need training for an entire department.

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.

  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.

The extension for some implantable devices does not apply to all Unique Device Identification (UDI) requirements.  The extension only applies to the label requirement.  Requirements to collect, store, normalize, validate and submit data to the Global UDI database (GUDID) must be met by September 24, 2015.

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.

It’s important to understand the capabilities of the new LIMS and develop a baseline of requirements at the beginning of the project.  It’s a good idea to have representatives from every department that will use the new LIMS participate in establishing the baseline of requirements, because departments within a company often have different requirements.  Kathleen Warner, Vice President of Project and Program Management at USDM Life Sciences says requirements for one particular LIMS project she worked on had to be revised four times because company representatives learned about new capabilities of the lab system during the project.

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.

If you have a Legacy LIMS system, talk to your Legacy vendor.  Another good method is to search the Internet for articles that discuss LIMS.  Do a search on the Internet for “top 10 LIMS vendors in regulatory environment.”  You will see some lists of current LIMS vendors as well as articles that discuss the best LIMS vendors.

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.

Some life sciences applications will need to be validated when they are moved to the Cloud. Legacy applications that you have already validated would maintain their validated state. But, often times when companies move applications to the Cloud, they add additional requirements and functionalities. USDM Life Sciences often helps companies move to a cloud based Customer Relationship Management (CRM) system and access their Enterprise Resource Planning (ERP) system in the field so sales staff can handle decision making, manage trunk stock and submit orders remotely. But, if you are moving data back and forth between your cloud based CRM and your ERP system, the data most likely needs to be maintained in a compliant manner.

Ultimately, whether an application must meet compliance requirements depends on the type of data you are using in the Cloud. For example, if you need to be able to track the activity of a medical device with GxP type of data, the application you are using needs to be validated.

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.

The time it takes to implement a new LIMS/Lab System depends on how big it is, how many users you have, whether you are going with an off-the-shelf system or a customized system.  It’s not unheard of for a LIMS system implementation to take over a year, from the time a proposal is requested to completion.

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.

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…
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