Capital Projects and Facility Services: Ushering a Digital Age in the Biopharma

Rick Kramer, President & Co-Founder The modus operandi of delivering capital projects in the pharma landscape— long-term investment projects requiring large sums to acquire, develop, improve, and maintain capital assets—via a traditional milestone event, continually adds to cost and time-burden. “The repercussion of such a conundrum has been consuming the pharma industry for some time now,” observes Rick Kramer, President and Co-Founder, Capital Projects and Facility Services(CPFS). The traditional project delivery methods deployed by companies neither digitally track nor connect the data with relevant assets to qualify a facility for licensure or long-term operational excellence through preventative maintenance programs. To put it succinctly, the pharma sector is tied in knots. Utilizing the CPFS methodology, services and associated cloud-based application, pharma companies can break-free. The company offers an advanced in-house software tool—webTOP—to drastically improve efficiency and reduce costs while delivering key project information and documentation electronically. “Clients are, therefore, empowered to get their facilities licensed, operate on schedule, and seamlessly feed their Computerized Maintenance Management Systems (CMMS),” states a confident Kramer.

The Burgeoning ‘Idea’

Leading upto CPFS, Kramer created computerized turn-over packages as an independent vendor. “I was able to present organized information online and on disk for pharma clients who realized it was exceedingly useful,” recalls Kramer. An idea began to germinate in Kramer’s mind when clients came back and asked for the information in print so it can be accumulated with the other information coming in for their capital projects. “Immediately, I realized the need for a full factory approach,” cites Kramer.

Commissioning and qualifying at the end of a project is expensive and time-consuming. It was a matter of time before Kramer figured that the usage of superior processes and software throughout the project life cycle could yield cost reductions up to 50 percent along with faster implementation. “The extra months of production creates enormous value for pharmaceuticals,” believes Kramer. The existing software needed to be replaced with a superior, secure, and enterprise wide computing environment. Lynn Donnell, Vice President and Co-founder of CPFS, and the CEO of Donnell Systems, provided the final piece of the puzzle. In 1993, Donnell’s company created Online Computer Information Exchange (OCIE)—an information management service that is a web-based cloud computing environment for mission critical applications at Heath Care, Government and Finance. Kramer knew instantly, OCIE is going to provide the base upon which he should build the software tool that could change the game for pharma clients.

Kramer partnered with Donnell to establish CPFS. “What drew my attention about OCIE is that it acts as an Extract- Transform-Load (ETL) tool for population of Business Intelligence (BI) systems and big data solutions, along with providing automated extraction of data from document content,” says Kramer. Designed to minimize network traffic and speed up delivery and manipulation of contents and documents, OCIE offers a cloud environment with servers located at customer sites or CPFS’s hosting site.“OCIE laid the foundation for webTOP,” says Donnell.

CPFS’ webTOP provides Information Supply Chain Management utilizing the required Turnover Packages (TOPs) and configures it digitally to load into the clients production systems and document management systems, all structure for Operational Excellence launch

A Ground breaking Methodology

“CPFS’ webTOP provides Information Supply Chain Management utilizing the required Turnover Packages (TOPs) and configures it digitally to load into the clients production systems and document management systems, all structure for Operational Excellence launch,” says Kramer. webTOP works to gather documentation in a useable format during facility construction. Additional programs are added to the collection and presentation of information, maintaining the integrity of the document management aspect of the system. It is then deliverable via a private cloud that allows a client to choose a server location, thereby, minimizing the dependence on public internet accessibility across borders. Such flexibility is a huge boom for pharma clients. The approach of managing a project based on asset tagged items, maintaining the relationship of data and documents to that asset, as well as, the ability to leverage tasks of data collection and verification t is where the overall cost savings and efficiencies come from.

The company combines webTOP technology with broad biopharma industry expertise to ensure full facility Food and Drug Administration (FDA) compliance as well as total lifecycle efficiency. “We provide a unique approach to project lifecycle execution, applying industry standards such as ASTM E2500, Building Information Modeling Construction Operations Building information exchange (BIM-COBie), and BIM 7D,” says Kramer. The application builds a unique bridge to other client-based applications.

Each implementation has its own unique propositions.“Along the way, we encounter a recurring requirement for enhancements to make webTOP more intuitive or add features and functions,” says Kramer. These requirements are captured and rated as per the level of importance and effort to update the core application. “webTOP is application-based, so all updates are done at the hosting server, not impacting the user’s PC software installations,” confirms Kramer.

This is not completely foreign to the industry, Eli Lilly and Company, a leading pharmaceutical, gained a definitive set of high quality deliverables which they leveraged in Commissioning and Qualification (C&Q) execution plans. Lilly’s success eliminated repetitive processes and additional resource needs. Employing the use of real-time capabilities, the CPFS webTOP platform targets deficiencies in earlier processes, making it easier to resolve problems and reduce costs maintaining schedule improvements. When combined with the cost savings typically achieved during set-up and vendor communications, the webTOP solution and CPFS Commissioning service delivers a significant step change in C&Q savings.
Bridging the Gap in Project Delivery

Navigating the siloed approach to pharma operations and steering capital expenditure project execution strategies offers one of the towering challenges in the biopharma space. “CPFS bridges the gaps in project delivery that are often left to the pharma operating plants to manage,” cites Donnell. Operating companies are structured to work in silos and discover what works best for each department leveraging the provided information. Often, this information is redundant. “From the initial configuration, CPFS consults with different departments or stakeholders to understand their needs and defines a collective repository of data collection requirements and appropriate tasking events to collect information,” says Donnell. Once the information is fed into the cloud application, the solution can map data and documents to other siloed applications. “The application can reside at the client’s location as a historical archive of collective data and documents with the ability to manage, change, or control as updates occur,” adds Kramer.

"We provide a unique approach to project lifecycle execution, applying industry standards such as ASTM E2500, BIM-COBie, and BIM 7D"

CPFS provides an indirect financial impact which can easily be recognized as a savings opportunity. “We offer this by virtue of quick access to data with the required associativity and traceability of physical assets and its related documents and datasets,” says Kramer. In the life sciences, there is high level of requirement from regulators. When asked to provide a supporting document with reference to a specific asset—be it calibration certificate, last maintenance performed, or proof of material used—it takes tedious effort to locate the documents. One must first decide the silo of information to search as well as understand the file structure. “Our application allows for an easy search based on asset tag and guides clients to the most current document, with a pre-determined file naming structure and data key structure, reducing overall effort and potential for errors,” assures Donnell.

“Today, the industry is attempting to leverage ‘big data’ to attain operational excellence; however, the means to get usable information is not an easy road to navigate,” observes Kramer. CPFS will continue to provide the map to extract feasible data and associated services in a nimble fashion. “Tomorrow may bring further needs such as managing batch record reference documents to help in defending product safety, crucial in the pharma space, or even knowledge management for which CPFS is well-equipped,” states Kramer. CPFS is the first company to offer solutions with state-of-the-art cloud-based software structured in a unique way to support the pharmaceutical industry. Surging ahead, “CPFS will become the industry standard for information collection and delivery manipulation. Also, we’ll set the bar for standard methodology for C&Q companies as they try to execute projects utilizing the ASTM E2500 method,” concludes Kramer.

Capital Projects and Facility Services

Sturtevant, WI

Rick Kramer, President & Co-Founder and Lynn Donnell Vice President & Co-Founder

Offers services, managing information for delivering a full facility electronic TOP

Capital Projects And Facility Services