A Smoke Study “delivers more than expected” at a major pharmaceutical manufacturer in Colorado

Photograph of a scientist working in a lab.


A major pharmaceutical manufacturer near Fort Collins, CO required a team of skilled and experienced professionals to complete a smoke study within their aseptic syringe filling suite.


When Performance Validation (PV) initially met with our client; they stressed the importance of requiring a team of experts to carry out the project. They did have one team member who could implement the smoke study; however, they understood it would take a larger team to carry out the mission properly. By choosing to partner with PV and our subject matter experts (SMEs), our client felt confident they would receive a more detailed and thorough study than they have received in the past.

During the planning stage, after reviewing the client’s previous smoke study videos, it was clear that large portions of the process were skipped, therefore our SMEs knew a standard approach would not suffice because it didn’t sufficiently analyze the aseptic interventions. Therefore, our team developed a tailored solution, which would not only cover the missing areas, but would provide our client with the complete and proper documentation for internal auditors and regulators.


The client had an important request to review the smoke study footage daily. While a daily review was not a standard PV procedure, our team was happy to comply with the request. The PV team downloaded the footage nightly and scheduled morning meetings with the client’s quality and validation teams to review for any findings that required attention before filming resumed. After addressing several findings from the operator’s processes which needed correction, PV SMEs requested to stop filming and continue the project by running scenes prior to turning on the cameras. This allowed our experts to share their extensive experience and knowledge with aseptic lines and smoke studies to explain how certain steps should be executed and how airflow was affected when not executed properly, including process flow and operators’ movements that were affecting the aseptic line airflow. This approach helped the client to improve its process during the execution of the critical airflow visualization study.

After experiencing the benefits from the daily footage, PV SMEs can recommend the daily review as a best practice for future airflow visualization projects.


Our SMEs knew from the previous footage provided by the client there would be challenges getting the smoke in the proper places. While adding a second large fogger during the smoke study was also a first-time element for the PV team, we were confident this would allow our team to film the process from contrasting different angles to provide sufficient examination of the critical airflow. The smoke helps people to visualize the airflow and understand how the proper execution of procedures, or deviations of the standard procedures, can affect the airflow, making the smoke study an excellent opportunity to train teams working on the daily operations of the aseptic line improving the process and minimizing quality risks.

Utilizing our thorough and meticulous approach and adding the second fogger played a crucial role in delivering a high-quality airflow visualization video and a precise final report.


PV approaches each project as an opportunity to provide tailored, innovative ways to offer the best service and solutions to our clients.

The extensive experience and knowledge of PV’s SMEs executing smoke studies, allowed our team to make crucial decisions and improvement suggestions during the planning and execution phases that improved the study’s quality and result. By taking the extra steps of adding a second fogger and additional cameras, PV was able to provide a more thorough and complete smoke study within the client’s timeframe.


Our client partnered with PV to help with their compliance. They wanted a team of experts to come in, set up their equipment, and provide a smoke study for their aseptic syringe filling suite. While we found several areas that were overlooked during previous smoke studies, PV was confident they could provide the right solutions for our client. Our experts took the time to educate and provide additional training for operators to help them fix their processes. PV was able to meet all the expectations and deliver the smoke study results within the tight deadline.

If you have a smoke study project coming up and would like to talk to our team of experts, please schedule a call to learn how PV can help!


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Semi-Automated & Automated Seidenader (Körber) Inspection System Upgrade with Large Pharmaceutical Manufacturer

Inspectors examining a facility

At a glance 

A client’s current automated inspection system was old and beyond its serviceable life. A new automated filing system and semi-automated system were purchased to increase production detection capabilities for parenteral presentations. 

New control system required integration with global system 

  1. Our client purchased an inspection system that included a relatively new control platform that would provide them with greater detection capabilities. The control platform also had to function with the other global systems, which was a major objective. 
  2. Our client made a commitment to the FDA to update its aging inspection system to meet new Probability of Detection (PoD) regulatory requirements with an aggressive timeline. 

Shakedown provided a faster path to successful validation  

This was a new platform for the client and knowledge was limited, especially on the new control platform, therefore PV immersed itself in understanding its capabilities and limitations. The knowledge gained allowed the team to quickly shakedown all customer requirements through high-level testing, and work through and resolve discrepancies with the equipment vendor.  

The shakedown approach allowed subsequent validation to be completed faster and at lower cost, with much smaller discrepancies and produced a more robust final solution. 

Shakedown: high-level testing that is performed to an application after it has been migrated or deployed to a given environment to assure that it is up and running without major glitches.” 

Additionally, in order to verify the new platform was communicating properly with the global system, PV assisted in testing the integration to ensure everything was properly captured within the client’s data historian system. 

Because of PV’s extensive shakedown and software expertise, our team was able to save time, money and assist our client in releasing a higher-quality product. 

SMEs supports client with new control system 

During this project, our team was faced with learning a new control platform and had to train the client in how the system works, under tight deadlines. PV’s SMEs provided the resources to support all the shakedown activities and learned the limitations and capabilities of the control system to provide our client with a successful validation. 


Our client purchased a new automated and semi-automated system to provide better inspection capabilities to help detect defects as well as future capabilities for high-voltage leak detection. The control platform was new to the client and had to be able to integrate with global systems and align globally in terms of approach. PV was able to learn the new platform and move products from the old semi-automatic machine to the new one while meeting updated FDA requirements. Our SMEs facilitated a heavy shakedown to ensure there were no issues with the system prior to starting the qualification process. Our teams worked hand in hand to ensure quality and patient safety were met. 

Since 1988, Performance Validation has been providing clients with expertise in the commissioning, qualification, and validation service areas in the FDA regulated industries. Our team thrives on the importance of quality, integrity, and teamwork, giving our clients peace of mind during every step of the project. 

Download the case study below:

Semi-Automated & Automated Seidenader (Körber) Inspection System Upgrade with Large Pharmaceutical Manufacturer

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Microsoft Dynamics 365 Computer Systems Validation

Simulated, futuristic computer screen with the words "Core Library" visible among many others.

At a glance
A medical device manufacturer was looking for assistance to make their Enterprise Resource Planning (ERP) system FDA compliant for an external audit coming up later in the year. 

The client did not have internal capabilities or the bandwidth to complete the validation. Their team lacked the expertise and knowledge to execute the project confidently. They were not familiar with how to approach a validation or what documentation they would need to create. 

PV worked with the client to learn their Standard Operating Procedures (SOPs) to develop a plan for the approaching audit. To facilitate communication and project deadline needs, PV set specific deadlines and follow-up policies to keep the team on track and moving forward. PV collaborated with quality and business users for feedback and aided in the decision-making for document development. 

PV used a risk-based approach to Computer System Validation (CSV) to determine the deliverables and level of testing needed for our client to provide the right documentation for the audit. PV’s risk-based approach is centered around our expertise in ISPE GAMP 5 and Computer Software Assurance (CSA) and many years of completing CSV projects. 

An additional challenge encountered during the project was a concern that the storage drive where the client stored the validation documents needed to be validated. PV was able to work with the client on their current procedures to verify all the right procedures were in place for the storage drive; they just needed assistance with the proper documentation. The client had very specific, very detailed validation SOPs, but no validation documentation templates. PV was able to modify its templates to meet the client’s SOPs. 

Another key component of the validation process is the Audit Trail. While the client did have an audit trail for the system, it was not easily accessible. PV helped define their audit trail needs to ensure regulatory compliance. 

When choosing PV as a CSV partner, our clients can be confident that the experience and dedication our team provides is nothing less than the best. PV can lead any project from any phase of the validation process, while efficiently placing protocols and guidelines early in the planning process to meet even the strictest deadlines.  

Our experience with applying CSA and GAMP 5 concepts in real-world scenarios allows our team to devise and execute the most efficient and compliant CSV solutions possible. 

The PV team streamlined the risk and gap validation analysis process, reducing costs and shortening the overall project timeline. The PV subject matter experts validated the proper functions of the system according to the intended use while assisting our client with preparing and finalizing the documentation needed to be audit ready. 

Since 1988, Performance Validation has been providing clients with expertise in the commissioning, qualification and validation service areas in the life science industries. Our team thrives on the importance of quality, integrity and teamwork, giving our clients peace of mind during every step of the project. 

Download the case study below:

Dynamics 365 Computer Systems Validation

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Dematic Automated Storage and Retrieval System Validation

Robots efficiently sorting hundreds of parcels per hour in a warehouse


A global pharmaceutical manufacturer was looking to boost its production capacity due to high market demand but was running out of space at its largest U.S. facility. The manufacturer’s team decided to recapitalize its existing warehouse space to make room for a new device line. After a rigorous qualification process, the manufacturer procured a Dematic Automated Storage and Retrieval System (ASRS) to leverage vertical product storage and reclaim valuable square footage to accomplish this goal. After the ASRS installation, Performance Validation (PV) worked with the manufacturer’s automation team and Dematic’s onsite team to validate the entire ASRS process while identifying gaps and implementing solutions to limit costly service interruptions. The automated warehouse would serve up to 20 different lines, so minimizing downtime would be critical to the project’s success.


  • The manufacturer was running out of space and wanted to install new lines for increased capacity.
  • The manufacturer had limited experience working with Dematic and Dematic’s systems/controls.
  • Staying on schedule for the ASRS launch and minimizing any downtime after go-live would be critical in maintaining production output for all device assembly and packaging lines at the facility.

The Solution

The pharmaceutical manufacturer’s onsite automation engineering team initially approached PV for its expertise in automated equipment validation and computer software validation (CSV) and previous experience with automated warehouse solutions. Within an extremely tight three-month execution timeframe (see the engineering shakedown and validation phases in the graphic below), PV worked with the manufacturer to develop a process for identifying — and solving — potential disruptions in the ASRS that could lead to expensive downtime and possible setbacks.  PV’s collaboration with the manufacturer on a rigorous Engineering Shakedown was the critical success factor in the project’s overall success. The 10-week shakedown process identified unique scenarios that could have resulted in potential issues. Working together as a team with both Dematic and the manufacturer’s automation engineers, PV was able to manage to correct these issues before Validation even began. PV started by addressing overall system safety activities before moving to manual equipment controls. Once the core components were functioning seamlessly, PV began evaluating the inbound and outbound pallet transfers and then evaluating fully automated controls. Ultimately, the Engineering Shakedown allowed PV to explore hundreds of potential disruption scenarios so that the final validation saw little-to-no surprises and was completed in only two weeks.

The Results

The manufacturer was thrilled with the project results. The PV and manufacturer’s automation team helped deliver a validated Automated Storage and Retrieval System (ASRS) that exceeded expectations around ASRS efficiency. The new Dematic Automated Storage and Retrieval System (ASRS) downtime is less than two hours a week on average, while other similar sites (using different ASRS systems) have reported downtimes exceeding 20 hours per week. Furthermore, by backing out the testing schedule during engineering shakedown, PV ensured that the warehouse would be fully operational by the required timeline.

Benefits of Working with Performance Validation

  • PV is an expert in the commissioning, qualification, and validation of complex capital equipment, which helps Pharmaceutical manufacturers meet aggressive schedules, hit ROI targets, and achieve and maintain compliance.
  • PV is committed to being part of the solution, working side by side with vendors, customers, and internal team members to find real-world solutions at the ground level.
  • PV is relentless in its pursuit of excellence. During the entire validation process, PV was focused on the system maintaining product identity, and no products were damaged.
  • PV “takes on the client’s pain as its own” with the ability to provide seasoned staff and resources around the clock to ensure a job is done well and on time.
  • PV validation engineers are lifelong learners who love what they do. They are driven to seek continual improvements, bringing a passion for problem-solving and extensive experience to every job.

Have a question about the ASRS validation process? If so, please get in touch with us through our Contact Us Form (http://perfval.com/contact-us/) and one of Performance Validation’s team members will be in touch.

About Performance Validation: Performance Validation is a 100% employee-owned company that has been serving the life science industries since 1988 and is a nationwide leader in providing commissioning, qualification, and validation (CQV), and building commissioning (Cx) services to FDA regulated pharmaceutical, medical device manufacturing, drug distribution facilities, to federal, state, and local government facilities and commercial building owners.

For more information:

David Tebbe


Principal Validation Engineer

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Automated Storage & Retrieval System (ASRS) Qualification

storage area at facility

Pharmaceutical Chilled Storage Facility – Automated Product Storage and Retrieval System C&Q

The Challenge

A large mid-western pharmaceutical company planned to install an automated product storage and retrieval system (AS/RS) within a new chilled storage facility. The idea was established as a way to better identify and document time the product spent outside of refrigeration as well as reduce risk for human error when handling the product on fork trucks. Two of the notable challenges on this project were that the AS/RS vendor did not have previous Pharma Industry experience, and that qualification of the system faced a shutdown driven “hard-date” for completion to accommodate product transfer from a another qualified chilled storage space.

The Solution

To ensure success, a commissioning and qualification (C&Q) plan was developed to ensure all functionality was tested thoroughly. This testing limited potential down time or product damage due to equipment failures. Performance Validation worked with the client and the AS/RS vendor to assist in defining the scope, determining user requirements, and developing testing for user and functional requirements. The following activities were implemented to maximize project success.

  • Performance Validation (PV) assisted in extensive engineering shakedown activities.  All test cases were dry ran to verify the system functioned as expected.  The PV team developed an expertise with the AS/RS system, such that when issues arose, PV staff were instrumental in investigation, root-cause analysis, and determination of solutions.
  • Performance Validation helped to develop a realistic C&Q schedule to maximize shakedown time.  Maximizing this shakedown window helped give peace of mind that the equipment would operate correctly during and after qualification.

The Results

The automated product storage and retrieval system was successfully installed and qualified in accordance with the project schedule, which allowed a seamless product storage transition to the newly qualified space.


Performance Validation coordinated with multiple stakeholders to successfully complete qualification of the AS/RS to meet an aggressive schedule. An extensive engineering shakedown process allowed for an expedited qualification period, with minimal testing issues. The client now has a validated state-of-the-art Automated Product Storage and Retrieval System, which is serving as a model for advances in storage and retrieval efficiency across the organization.

For more information, please schedule a call with one of our subject matter experts. 

Brad Henry
Vice President & Division Director, Indiana
Performance Validation, LLC.

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Kaye Validator AVS ICAL Software Validation

Digital illustration of coding and other sci-fi elements over a hand on a keyboard

The Challenges

A manufacturing division of a major pharmaceutical corporation owned and operated a number of Kaye Validator thermal validation systems. Historically, the facility’s Metrology department had outsourced the scheduled calibration of the Kaye Validators and their sensor input modules (SIMs) to the vendor, which limited their control over the time it took to return the units to service.  In the interest of simplifying the logistics and minimizing the turnaround time for these calibrations, the Metrology unit purchased the vendor’s Kaye Validator AVS ICALcalibration software system to perform calibrations in-house. 

It was determined by the manufacturer’s quality team that the software system, which automated the calibration process and reported its results in a certificate of calibration, was subject to the rules of 21 CFR Part 11 (i.e. Part 11) for electronic records, as well as 21 CFR 58.63 for the maintenance and calibration of equipment.  As such, the corporation reached out to Performance Validation (PV) software validation support.

While the manufacturing division’s was governed under a robust verification and validation (V&V) system based on ASTM guidelines, it had relied on its business technology (BT) division the ownership and support of software validation of in the past.  As a Metrology tool, the new ICAL software did not fall under the ownership of the BT services division. This presented a challenge for the stakeholders to produce a software validation package that would comply with Part 11, while also satisfying the requirements of the division’s V&V procedures.

The Solution

The PV Computer System Validation (CSV) team was called in to lead the validation effort. The CSV team member worked with client stakeholders to determine a means of assimilating a GAMP software validation approach within the framework of the client’s V&V procedures.  The CSV team member initiated and managed the V&V project within the client’s electronic change control system.

The process began with business risk and quality risk assessments.  Initially, the vendor’s off-the-shelf software package seemed to present no unusual risks beyond possible failure of its intrinsic functionally.  The software was provided by a qualified vendor and required no configuration for its intended use. However, per the client’s procedure, the software system was formally assessed to identify any possible gaps in data integrity requirements.  The assessment determined that, although the resulting certificate of calibration report would be printed to hard-copy and controlled under formal engineering document management as the primary record, the electronic report file and intermediate data files used to generate the report file were not adequately controlled and protected by the vendor software, as delivered.

It was also recognized that the software was intended to run in a Windows 7 environment.  This presented additional risk, as Windows 7 was no longer supported by the business technology division. Replacement of a Windows 7 system would be an obstacle for recovery of the ICAL installation in the event of hardware or operating system failure on the host computer.

In order to mitigate the identified risks, the team turned to their automation engineering resource to install the ICAL software in a Window 7 VMWare environment and create custom code to automate the backup of the electronic report file and intermediate data files to a secure network directory.

With the risk mitigation solutions identified, the PV CSV team member completed the risk assessment documents .  Based on the findings of the assessment and the requirements for implementation of the ICAL software system identified therein, the PV CSV team member  drafted a verification qualification strategy to prescribe acceptance criteria and related verification testing measures. A technical document for configuration and backup/recovery was developed and approved.  Work instructions for system software use were created and activated in the Maintenance electronic management system.

A verification testing protocol was developed by the PV CSV team member in collaboration with the automation engineer and the Metrology end-user, and the verification testing was completed successfully.

The Results

The ICAL software system was qualified for implementation in the Metrology unit, enabling Operations to receive timely calibration services for their Kaye Validator systems in support of further thermal validation projects.

The Benefits

The PV CSV team member provided the experience and insight to integrate the GAMP approach to computer system validation within the client’s V&V process.

Throughout the project, several stakeholders (i.e., Metrology, Maintenance, Operations, Engineering Compliance, Validation Quality, Data Integrity, and Engineering  were required to weigh in on the approach to mitigation of risks. Several risks and possible mitigation solutions were considered and agreements made under team consensus. Several obstacles in stakeholder and resource availability affected the project schedule.  However, working with the engineering project manager, the PV team member was able to satisfy the affected timelines.

The PV CSV team member was committed to staying on top of this coordinated effort by scheduling regular team meetings and facilitating continuous electronic communication with stakeholders to identify and resolve issues in a timely manner.

Have a question on computer system validation? If so, please contact us using use our Contact Us form or Kevin Marcial.

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IBM Clinical Development EDC Validation

Office worker at computer

The Challenge

A global organization that develops, manufactures and sells diagnostic instruments and related software needed validation for their cloud based Electronic Data Capture “EDC” platform, “IBM Clinical Development” to help reduce the time and cost of clinical trials.  Their clinical sites would enter study data into the software and it would expedite their data review and processing. The data could be analyzed before submitting Case Report Forms (CRFs). EDC system validation has unique data integrity aspects that must be considered.

The client wanted assistance from a company that had experience validating a Software as a Service (SaaS) platform. Their data would eventually be analyzed by Microsoft R so familiarity with that software could provide added benefit.   Microsoft R is a platform which performs data manipulation and statistical analysis. The client used it to perform multiple complex calculations on instrument data and CRFs.

The Solution

Performance Validation had just finished validating Microsoft R for the client successfully.  That solution is also a “SaaS” which was validated within their time constraints and complied to their Quality Assurance program.  Validating a SaaS platform is a newer challenge for organizations since the application is not physically installed at the clients site and there is potential that upgrades/modifications are deployed by someone not within your organization.  The vendor of the software and/or host of the application need to be thoroughly evaluated and a Service Level Agreement (SLA) agreed upon stating access to confidential data in the system is limited to approved employees and not updated without a change control procedure. The installation qualification becomes smaller since it outlines the thin client portion of requirements and not the larger virtual infrastructure. Our familiarity with the data and business operations of the client really allowed us to be efficient in the EDC validation project. 

PV was determined to be a logical, cost effective choice for bringing their IBM Clinical Development application into compliance.   The client benefited from a remote worker writing the supporting documentation and executing without incurring travel costs. After the initial User Requirements Specification was drafted, the decision was made to use the clients new validation templates.  PV determined this was acceptable and were able to adapt the changes to what was provided. Collaborating with a member of their Quality Assurance department occurred to ensure their templates were completed consistently without future rework.

The Results

The project was completed on schedule and within budget.  Correspondence for the project consisted of phone and email updates.  The client wanted to leverage vendor testing where possible and made the focus of Customer and Functional Requirements based on the Roles used within their organization.  PV adhered to the newly created client templates and worked with QA to ensure an expedited inspection at the end of the project. 

Have a question on Computer Systems Validation, or application of Data Integrity principles, contact Kevin Marcial.

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Quality Assurance – Designed for Construction

two workers at construction site

The Challenge

In 2003, a large pharmaceutical and biotechnology company was experiencing cost overruns, project delays and other cost-of-quality issues that have become the norm on recent projects.  Many questions existed and answers were needed for questions such as:

  • Are we using contractors who do not have a quality program?
  • Are their quality programs effective?
  • How do the quality programs compare to industry standards?
  • What can we do to assist contractors in improving their quality programs?
  • What will be our expectations for contractors in the future?

Further investigation revealed that the construction industry, as a whole, has been struggling with quality issues for many years, and the cost to our economy has been dramatic.  Although quality assurance has been used with great success in other sectors of the economy, it has bee for the most part completely ignored by the construction industry.

The Solution

Performance Validation formed a partnership to begin a pilot program to find answers and to develop solutions.  In Phase I, the following valuable information was uncovered.

  • Approximately 50% of the contractors did not have Quality Manuals
  • Many contractors did not know what a Quality Manual was and confused it with a Safety Manual, Operations Manual, or an insurance investigation.
  • Construction contractors did not know what was expected in a quality program.
  • Some of the quality manuals that did exist were only window dressing and were not utilized.

In Phase II, a Construction Quality System Audit Checklist tailored specifically for the construction industry was developed to assess the strengths and weaknesses of a construction contractor’s quality system.  A checklist with similar metrics was also developed for Jobsite quality audits.

In Phase III, a Construction Quality Assurance Program was developed that included a Corporate Quality Assurance Manual, Quality Procedures, and a Job Specific Quality Plan Template along with associated forms, checklists and other quality system documents.

The entire system was designed to meet the needs of the construction industry by being streamlined and user-friendly while incorporating a risk-based approach that minimized cost.  Mistake-proofing and closed-loop methods were included in the design in order to build quality into the process!

The Results

  • The building owner was able to build a database of audit results to measure continuous improvement with its construction contractor partners.
  • The building owner utilized quality audit results to assess the quality system capabilities of four contractors bidding on a $100 million facility and avoided making a costly error.
  • A local construction management firm has begun implementing the construction quality assurance program to build quality into the process, minimize risk and optimize profits. Other construction contractors are now aware of how they can improve quality    systematically while simultaneously reducing risk and improving profits.

The Benefits

  • Quality System Audits: Building owners can utilize construction quality assurance to assess the capabilities of the construction companies with whom they conduct business to avoid making contract decisions based solely on safety and lowest bid, a poor strategy that has cost millions of dollars in project delays.
  • Jobsite Quality Audits:  A standardized tool is now available for unbiased, 3rd party audits to be conducted.
    • Building owners are provided a feedback mechanism to keep from “flying blind” to ensure that quality is being managed, and to ensure that quality issues are caught early on before unnecessary liability is accumulated that could threaten project delivery.
    • Contractors benefit from knowing how they are doing and are alerted to issues which can be corrected before large liabilities accumulate.
  • Quality Assurance Program Designed for Construction:  Contractors can now have a quality system that strikes the right balance between cost and added value.  The ability to assure quality, rather than just promise quality, becomes a reality.  Mitigation of risk while adding value now works in harmony rather than conflict to add real results to the bottom line while protecting the business.

For more information on Performance Validation’s Building Commissioning expertise please schedule a call with one of our subject matter experts. 

Brad Henry
Vice President. Division Director, Indiana
Performance Validation, LLC.

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Data Integrity Assessment Project Summary

office worker with hands on laptop

The Challenge

The 2016 publication of FDA draft guidance document (“Data Integrity and Compliance with CGMP”) along with increased warning letters / 483s have generated an increased attention toward data integrity issues among FDA regulated industries.  As a result, companies in the affected industries have begun instituting or updating their data integrity policies and best practices.  A major manufacturing facility for a large pharmaceutical corporation initiated a comprehensive effort to proactively identify and address any potential concerns with data integrity.  This effort entailed the assessment of hundreds of their data systems, involving both paper-based and electronic records, to ensure that their data systems were in compliance with their own data integrity procedures and that their procedures aligned with industry best practices.

This manufacturing facility had two physical sites that needed to be assessed for data integrity gaps. Both sites needed to comply with the corporate policy on data integrity and needed objective evidence of compliance. Having relied on Performance Validation (PV) for many years to provide onsite validation and verification support for multiple sites, this client contacted PV for assistance in their data integrity assessment project.

 The Solution

The data integrity assessment project planning process determined what systems would need to be assessed and how to assess them. Clearly, the individual assessment of hundreds of systems would not be an efficient or necessary use of project resources. Rather, the company categorized the systems. Three categories of systems were identified based on data type:  paper records (e.g. forms, logbooks), equipment (e.g. instruments, devices), and computerized systems (e.g. ERP, LIMS, SCADA). Paper records and equipment would receive the same “ALCOA” assessment (see next paragraph). Computerized systems would receive the paper/equipment assessment along with an additional 21 CFR Part 11 compliance assessment.  Redundant systems would be addressed under one common assessment.

The assessment criteria were prescribed based upon the principles of “ALCOA”. ALCOA, is at the cornerstone of data integrity principles, which states that data must be Attributable, Legible, Contemporaneous, Original, and Accurate. The company also adopted the “ALOCA +” concept which adds Complete, Consistent, Enduring, and Available. A questionnaire was constructed, organized according to each component of ALCOA. Questions addressing the legibility of data were grouped together, for example. Each question was worded to elicit a Boolean response (yes/no), and provided a field for detailing gaps (if a “no” was answered), gap mitigations (including emergency actions if needed), and deadlines. A weighting value was attached to each yes or no answer which was used to tabulate a final score resulting in a quantitative pass or fail result.

Subject matter experts (SMEs) for each system were assigned to help PV with the assessment process. PV staff conducted the assessments and managed the process. This involved scheduling and holding meetings with the SMEs to answer the questions on the assessments. PV staff delivered expertise gained through years of training and experience in data integrity and 21 CFR Part 11 to offer guidance for answering the questions and to provide consultation on gap remediation. The assessments were documented by PV and concerns were communicated to the stakeholders including Quality Assurance and the business process owners.

The Results

All data integrity assessments were completed on time and under the project budget. PV performed the assessments and aided in the stakeholder approval process.

 The Benefits

The company now has a clear picture of the types of data integrity gaps and concerns they have relating to the systems that were assessed. They were able to obtain objective information on their compliance status from a data integrity standpoint and make this valuable information available to key decision-makers in the company. More importantly, they gained a conclusive list of specific action items to be completed.  Some action items were specific and unique. For example, some systems did not employ audit trail retention practices, or if they did, their practices were vague and lacked accountability. Some action items targeted broader, site-wide quality system issues. For example, the organization had a procedure stating that they intended to perform risk analysis in support of a risk-based approach to compliance, but did not document the process or show objective evidence of risk in practice. With this project complete, they now have the ability to effectively address data integrity in their organization.

The PV Advantage

The PV staff provided the expertise and knowledge needed to ensure an efficient high-quality data integrity assessment of the systems. They knew how to ask the right questions and delve into the nuances of a system to make sure no stone went unturned when looking at data integrity. Project and document management was also handled by PV, relieving the client of concerns over the compilation, construction, and routing of documentation. Moreover, PV provided knowledgeable guidance on how to resolve the gaps discovered by the data integrity assessments, and will continue to aide in the remediation process for this client.

For more information please schedule a call with one of our subject matter experts.

Kevin Marcial

CSV Services Manager

Performance Validation

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Trackwise Project Summary

closeup of hand on tablet surface

The Challenge

A leading medical device company was underway on two projects intending to launch new global business information systems; an electronic CAPA management system and a product complaint handling system. Both systems were being developed in a TrackWise® system environment with the collaboration of the software vendor, Sparta Systems, and the in-house development team.

For the electronic TrackWise CAPA management system, the client required computer system validation support to complete the qualification testing phase of the project.

For the TrackWise complaint handling system, the client required full end-to-end validation services, including validation leadership for personnel involved in the final qualification processes.

The following business considerations were addressed by the TrackWise complaint handling system:

  • compliance with applicable regulatory body requirements
  • multiple data entry sources, including TrackWise® project forms, a web-based end user form, and a mobile iPad application for company representatives
  • interface with multiple data hubs for acquisition of product, personnel, and customer record data
  • complex schemas for electronic record relationships and process workflows to be performed by multiple user permission groups
  • electronic submission of adverse event reports via web-based XML solutions to the FDA (Medical Device Reports) and the appropriate European Competent Authority Agency (Medical Device Vigilance)
  • adverse event reports for many specific countries, delivered in native language and agency prescribed formats, using custom developed Crystal reports
  • tracking, trending, reporting, and automatic notifications for day-to-day complaint record management, to enable timely business decisions and efficient work processes

These projects, extensive in their scale and complexity, were subject to strict deadlines for implementation and an aggressive schedule.

The PV Advantage

Performance Validation provided the client with an experienced validation project team and Project Leader. Based upon project needs, Performance Validation responded by providing:

  • a risk-based validation based approach, modeled after ISPE’s GAMP 5, employed to maximize project validation quality and efficiency
  • a working partnership with the client Regulatory and Quality Assurance representatives to ensure that the new systems were compliant with 21 CFR PART 11: ELECTRONIC RECORDS; ELECTRONIC SIGNATURES, 21 CFR PART 820: QUALITY SYSTEM REGULATION, and 21 CFR PART 803: MEDICAL DEVICE REPORTING
  • experienced validation planning and coordination
  • effective collaboration with the IT Business Analyst, Development Team, and IT Quality to develop a comprehensive suite of system documentation that encompassed all of the system business requirements, functional requirements and design specifications, and testing documentation
  • system documentation that was intentionally designed to facilitate testability and ready traceability of all system configuration and functionality
  • detailed functional review of the system, performed at the clients request prior to initiation of the project’s formal validation testing phase, to reconcile the system development to the approved requirements and specifications
  • comprehensive testing strategy, test scripts, pre-qualification (dry run) execution, and script error corrections prior to initiation of formal validation testing
  • efficient execution of validation test scripts, including timely deviation reports, resolution management, and validation test summary reports
  • flexible and decisive validation solutions to accommodate business requirement changes during the validation testing phase
  • knowledgeable and experienced system change control support following deployment of the validated TrackWise® systems
  • formal periodic status reports along with frequent client interaction to provide stakeholders timely information regarding project management elements such as costs, timeline, and scope control

In order to accommodate demanding project schedules and deadlines, the Performance Validation team was committed to providing the additional man-hours necessary to ensure the client with on-time delivery of these validation services, and to provide the client project managers with peace of mind.

The Results

System validation activities for the TrackWise CAPA and Complaint Handling systems were completed on time, allowing the client to meet their overall system implementation deadlines.

Through the collaborative efforts of the Performance Validation team with all client stakeholders, the client was able to deliver top quality global systems that meet the business process requirements.

In subsequent internal and external audits of the system by the client and regulatory agencies (FDA) validation documentation delivered by the Performance Validation team, the systems were determined to be in an exemplary state of compliance with both client internal standards and regulatory agency requirements.

Following completion of the system implementations, Performance Validation team members were retained by the client to ensure continuation of compliance with a high standard of quality in support of system life-cycle change control and to maintain the systems in a validated state.

The Benefits

Performance Validation provided the client with:

  • high quality validation project consultation, deliverables, and execution through understanding the project, the stakeholders, and validation quality expectations
  • a validation approach custom designed for the scope and complexity of global information system
  • flexible allocation of project validation team resources in response to project needs
  • diligent attention to changes in system requirements, functions, and configurations throughout the development and validation cycles, with immediate assessment of impact to validation considerations, and follow-up revisions to all pertinent documentation
  • affective communication and cohesive working relationships with all project stakeholders
  • continued system life cycle change control support beyond the systems’ go-live dates

For more information please, schedule a call with one of our subject matter experts. 

Kevin Marcial,
CSV Services Manager

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