The Healthcare industry spans multiple segments, such as the pharmaceutical, biotechnology, healthcare provider, child clinics, healthcare insurance, and research segments. All these contribute directly or indirectly towards patient care or drug development.
Y&L brings industry expertise covering a variety of manufacturing and retail nuances. We understand manufacturing criticalities, procurement, production, shop floor control, sales, customer management, quality, and supply chain management.The focus is to improve operational efficiencies, reduce risk and cost, and improve customer service. Y&L provides a wide range of business consulting, systems implementation, and process management services to its healthcare clients.
Y&L helps healthcare organizations improve their IT architecture to support and adapt to constant changes and provides value-added services to help manage healthcare facilities as enterprises and provide decision support systems. In addition to application development, Y&L also provides much-needed network infrastructure support in terms of creating Wi-Fi hotspots and facility connectivity to allow physicians to work wirelessly on tablets to update patient records.
Ask us about the work we have done for BlueCross/BlueShield, Thermo Fisher Scientific, Vidacare, PharMerica, United Allergy Services, CaptureRx, Wellmed, Onco 360, Nightingale Home Healthcare Services, Boxhill Hospital, Shriner’s Hospital, BioBridge Global, HVHC, Mission Pharmacal, Southwest Research Institute, Charles River, Smith & Nephew and Merck.
Y&L SAP Pharma Rapid Deployment Solution (RDS)
Based upon extensive experience, Y&L has developed a pre-configured Rapid Deployment Solution (RDS) for SAP Pharma based upon our industry best practices and contains a built-in GxP control specifically for pharmaceutical companies. Y&L’s Pharma RDS solution can help reduce your Total Cost of Ownership and regulatory compliance risks, while improving quality management and innovation.
PharmaOne is a comprehensive, prepackaged SAP® Business All-in-One ERP solution designed specifically for the pharmaceutical manufacturing industry. Leading pharmaceutical and biotechnology manufacturers are leveraging PharmaOne to improve operational efficiency, increase employee productivity, and respond to market demands with agility.
PharmaOne delivers the necessary tools to improve business performance:
Adherence to FDA compliance
Track and manage plant-wide data with ease
Tight integration with finance and improved cost visibility
FIFO-FEFO batch determination, shelf life monitoring, traceability and Electronic Batch Record (EBR)
102 GxP In-built controls
Computer Validation Services for FDA Compliance
Organizations in the life sciences industries must comply with the Computer System Validation (CSV) requirement that is issued from the FDA. The regulation mandates that companies in the life sciences industries have the specific controls and procedures in place to consistently produce results that meet its predetermined specification and quality attributes.
Y&L brings a thorough understanding of this requirement and a practical risk-based approach to CSV and helps enable life science customers to meet global regulatory requirements, eliminating the GxP compliance risk. Our highly qualified and experienced consultants have real-world domain experience and have the right capabilities and tools to tackle ERP, manufacturing, laboratory, and clinical systems.
Y&L’s CSV compliance services include:
CSV Compliance Services
Details of Services
End to End Computer System Validation Services
Offered for any GxP sensitive computer system implementation, development, upgrade, and rollout project, services include: IQ, OQ, PQ with all other validation deliverables as per GAMP 5 standards. The services also include GxP Control Mitigation and 21 CFR Part 11 Analysis. Y&L has standard approved CSV templates, processes and procedures, tools, reusable assets like User Requirements, Functional Requirements, etc. which helps reduce the CSV timelines.
21 CFR Part 11 Analysis and System Remediation
21 CFR Part 11 Analysis and Remediation is conducted as part of CSV end to end validation services or separately if 21 CFR Part 11 compliance is not implemented. 21 CFR Part 11 is also referred to as Electronic Records and Signatures and is mandatory for FDA regulated industry to comply.
GxP Risk Assessment and Control Mitigation
GxP Risk Assessment and Control Mitigation is conducted as part of CSV end to end validation services or separately if GxP Controls are not implemented or found missing during CSV audit. Y&L has a robust GxP Risk Assessment Tool to enable, track and incorporate GxP Control Requirement in the GxP System.
Validation Testing Services
Validation Testing Services is an independent service where Y&L provides functional resources with the relevant functional and CSV expertise to execute validation testing of GxP System and ensure objective evidence in form of proper documented evidence adhering to Good Testing and Documentation Best Practices. Validation Testing Services can be offered as part of CSV end to end services or a separate service and can also be executed 100% offshore.
Quality Assurance Review
Quality Assurance (QA) Review service is an independent service offering for review of all Validation deliverables. QA Review service can also be offered during Validation Testing with independence of Review maintained if Y&L is also performing Validation Testing Services.
CSV Audit is conducted periodically preferably annually to check the compliance health of Validated and Non Validated GxP System. Y&L will conduct the CSV Audit and generate a CSV Audit report along with mitigating steps and procedures. Y&L can also help customers to close on compliance gaps.
Improving Data Reliability for Decision-Making
A pharmacy management services organization was utilizing an AS400 system and Brio to make data queries. This manual process didn’t regulate data consistency or provide a user-friendly experience. Although leveraging Cognos gave answers to predetermined questions, they wanted to answer exploratory questions.
Y&L worked with the executive team to understand what business problems required solving, current processes and the data-flow supporting these processes. Ultimately, a full end-to-end data solution was agreed upon; Microsoft stack on the backend with Qlik Sense empowering users on the frontend.
A SQL Server Database environment was implemented to ingest AS400 data. With the correct architecture, rules, and cleansing checks, this implementation served as the foundation for clean and trusted data and supported the backend architecture for frontend tools.
With the SQL Server implementation in place, the Y&L team began attacking questions in the visualization tool – Qlik Sense. In the course of a year, 6 enterprise applications were built, consisting of 8 reporting dashboards per application, providing at-a-glance insights, standardized KPIs, actionable & drillable visualizations, and user-friendly self-service tools.
EHR QA Testing
A healthcare IT solution provider chose Y&L to provide end-to-end QA services for their Electronic Health Record (EHR) product. Y&L provided Integration/Interface testing, System Testing, and User Acceptance Testing (UAT) services leveraging domain and manual testing solution services. The product knowledge and understanding on healthcare regulatory compliance aspects of Y&L testers played a key role in developing a complete regression test suite for the product.
The Product Life Cycle followed Scrum methodology and the team provided automation solution/services using the “Test Complete” tool. The resulting benefits included a reduced time-to-market, accelerated product maintenance/patch releases and 30% in cost savings.
SAP Implementation – Process Automation
A post-acute and long-term care full service pharmacy was relying on several legacy systems to handle its Record-to-Report process. The main problem was a lack of visibility across multiple systems as well as several manual processes. In order to streamline business processes and gain transparency across each line of business a change needed to be made.
Working together to replace multiple outdated technologies with an optimized SAP solution, Y&L was able to provide an end-to-end accounting system allowing the client to develop reports and balance statements to perform in-dept forecasting.
Y&L Healthcare SAP specialists implemented the SAP Collections Module (SAP RM) to support receivable management and prioritize the customer receivables function based on defined rules. This automation replaced the manual spreadsheet process of performing client collections. The client now has full visibility across collection teams and full reporting capabilities. With the successful implementation of SAP Collections Management, the client has reduced the crucial Days Sales Outstanding (DSO) significantly.
Automation Drives Additional Revenue
A healthcare organization had an opportunity to take advantage of a recent drug rebate policy. However, the client needed to pull data from multiple sources, format customer claims, validate rebate eligibility and process them within their system.
Y&L built a robust ETL package for the client to pull claims from mulitiple sources and generate claims files. Claims and rebate files now seamlessly flowed through sFTP between the vendor and the client.
The processed output data is stored in their database and accurate reports can now be generated. The system now automatically consolidates claims files, dropping and picking-up from sFTP folders, exchanging information between the client and vendor systems and processing the output files.
Innovative Application Development
Our client manages one of the best 340B contracted pharmacy network and is a technology leader in 340B processing and automation. They wanted to enter the Medicaid market for the reclassification of 340B claims.
Create a process for MCOs, pharmacies and 340B administrators to submit data files for claims identification.
Create a scalable, comprehensive and robust solution for MCOs to demonstrate to the State an effective 340B compliance and performance program across both retail and specialty pharmacy patients.
Identify and report to the State all Medicaid claims in which the ingredient cost was purchased with 340B discounted prices.
Create a solution to share 340B data, savings, performance and refunds using agreed upon standards.
Prepare shared savings invoices and reports and settle funds collection and payments.
Y&L created a solution containing multiple integrations/interfaces, a flexible and scalable audit rules engine and multiple web-based portals as well as delivered the following:
Scalable – Expected monthly claim volume of 100+ million
Hippa Compliance – Safeguards for handling and data transmission
Claims Management – Handle single and multi-payer claims and identify claims between the MCO and Entity to calculate savings.
Governance – Track claims from source data to invoicing rejection.
First -To-Market - Successfully created a new market space delivering significant revenue to client, MCOs and other entities.
Revenue Recognition - 606 Challenge
The ASC 606 revenue recognition standard affects all entities—public, private, and not-for-profit—that either enters into contracts with customers to transfer goods or services or enters into contracts for the transfer of nonfinancial assets. In order to adopt the ASC 606 revenue recognition regulatory standards, companies need to have their revenue related to transactions, requiring their reference data and master data to be consolidated and integrated.
One of our healthcare client’s had a major challenge in adopting the ASC 606 standard because of their diverse revenue data platform combined with no uniformity in their revenue data standards.
Y&L professionals developed an Enterprise Data Management (EDM) solution and Data Governance strategy that helped our client:
Follow uniform policies and procedures for their data integration methodology
Utilize Master-data & Metadata management tools and procedures
Implement data quality standard procedures
Follow data architecture standards
Implement an Enterprise Revenue Data integration platform
This initiative enabled our client to comply with ASC 606 standards.
Increasing Financial Accuracy from 75% to 90%
One of the fastest growing biopharmaceutical companies which researches, develops, manufactures and markets injectable biological, pharmaceutical and biotech products was operating on different systems for multiple departments and were noticing errors in their data integration and Management Information System (MIS). Furthermore, reports were manually created in external spreadsheets and ad-hoc parameters were used making resulting data findings questionable.
The client sought a centralized and controlled system for all data in order to increase governance and transparency.
Y&L was selected to install enhancement package 6 for SAP ECC onsite and implement the FICO, SD, MM, HCM, PP, EXIM and Workflow modules. Our implementation team utilized multiple technology components including SAP Netviewer, ABAP, ECC and Microsoft SQL database. In addition, during the development we customized more than 100 ABAP reports.
This implementation resulted in enhanced business processes, including the month closing process and MIS preparation. Financial management processes increased in accuracy from 75% to 90%.
Mobile Solution for Home Healthcare
Our client, a pioneer in the realm of home healthcare services, was looking for a mobile solution that could monitor the vitals of patients through devices like a pulse oximeter, thermometer, etc. and store them in a repository as part of patient monitoring and record keeping. In addition to monitoring, should there be an abrupt deviation, the client wanted text alerts to the attending physicians and allow them the ability to see the real-time information and reach out to the patients remotely.
For the patient, the mobile app would also send daily reminders for taking their medicines and allow them to locate nearby physicians specialists if needed (cardiologist, etc.). Y&L created a mobile application that would capture and present health readings by pairing medical device APIs with the mobile application and send those results to the Admin app via AWS. An interface for test scheduling via AWS was also created and mobile-enabled. The solution is hosted on the cloud and therefore there was no need for the client to have to invest in additional hardware.
Continuous Innovation & Improvement at a General Hospital
From simple beginnings as a maternity hospital to its growth into a fully-fledged hospital, our client reached out to us to help them make improvements in their operational efficiency and perform software upgrades as well as ensure the readiness of their IT systems to better integrate new healthcare organizations via expansion and/or acquisition.
Y&L provided AMS support via a combination of onsite and offshore resources across the SAP landscape and implemented ISH, I.S.H. med, FI, CO, MM, HR, PM and POS modules as well as integration with RI and LIS. Our consultants completed an end-to-end integration between all processes and performed upgrades on enhancement packs.
Some of the results of this initiative:
Reduction in claims rejection rate from 2% to 0.2%
The automation of Accounts Receivable, Package Pricing and Billing
Workflow automation for the Treasury Desk as well as consumption and billing for items used in the OR
Improved physical inventory process through barcoding solution