Enterprise Resource Planning & Solutions (ERP & SAP) Capabilities
The Kymanox Intelligent Enterprise Team is an international provider of ERP Optimization, Implementation and Compliance solutions for life sciences. We offer a unique patient-centric, risk-based approach balanced with both regulatory requirements and business needs.
01
Compliant Manufacturing
For 21 CFR Part 11 Compliance, Kymanox offers efficient process mapping, SOPs, batch, device history records, lot release (raw materials, intermediates, and final product), QC sampling, testing, reporting, product expiration management, and serialization.
Explore More
02
ERP Quality & Compliance
The information and communication technology (ICT) field is full of technologies and applications that can be used. This includes broadband technologies, which have had widespread use, now followed.
Explore More
03
Supply Chain
From process evaluation and optimization from supplier qualification and quality audits, third party logistics, and stock transfers, to DEA/ARCOS Reporting, and material identification & tracking.
Explore More
04
Order to Cash
Kymanox offfers compliant order to cash, including product recalls, returns, purchase orders, and stock reorder suggestions & forecasts.
Explore More
Meet our Enterprise Resource Planning & Solutions (ERP & SAP) Experts
Bradford Booth, CPGP, SM
ASSOCIATE DIRECTOR, ENTERPRISE QUALITY
Helpful Links
Here are some of our favorite resources on this topic
Markets That Benefit from Our Enterprise Resource Planning & Solutions
Combination Products
Our experts understand the interaction between devices and drug products. Our experience includes injectables, nasal, respiratory, and more.
Biologics and Cell & Gene Therapy Services
We understand why “the product is the process” and how to implement solutions to your unique challenges.
The Kymanox Enterprise Resource Planning & Solutions (ERP & SAP) Difference
Our clients tell us traditional integrators simply do not fully understand the complexities of working in a highly regulated environment. The Kymanox team lives in regulatory environments every day so you’ll get practical solutions.
Proven Broad Expertise
Our team of experts is focused on life sciences with extensive experience across drug and device development. No matter your challenge, we can help you conquer it.
Flexibility & Agility
At Kymanox, we make it easy for clients to get the solutions they need, when they need it. Clients tell us our flexibility is one of the key reasons they keep coming back.
Dynamic Project Management
A personalized approach to project management that combines your needs with our proven tools and expertise to create a custom solution for your project.
Frequently Asked ERP Questions (FAQs)
Why is ERP important to life science organizations?
For life science companies tasked with bringing modern medicines to market, having a well-designed ERP in place allows for greater data integration resulting in better operational control, visibility, and the quality of information throughout the entire enterprise. There is no more essential foundation in our highly regulated industry that offers a better platform to improve profitability through greater efficiencies in planning, production, supply chains, as well as fine-tuning operations and compliance than with an ERP. This is true especially when coupled with modern analytics.
How should an organization approach an ERP program?
An ERP initiative is a complex undertaking in any industry, but particularly so in an industry with regulatory oversight. The most effective approach is to view an ERP engagement not as IT project but as a holistic business transformation effort. Life science customers should have a well-defined business case that captures their quantifiable objectives, industry best practices, and includes thorough process inventories required for compliant operations. Client-side participation is critical and must employ process owners who are close to daily tasks and can offer the project team deep insights from each department.
What are some of the best practices to enable transformational efficiency with an ERP implementation?
Successful organizations take the view of their ERP as a digital change enablement tool built on a solid business case with clearly defined operational objectives. As with most industries, life science ERP systems incorporate standard processes that are based upon best business practices. Unlocking the value of best practices is facilitated with a focus on end user participation and stakeholder involvement throughout the full life cycle of the ERP initiative.
Their active participation ensures that critical processes are correctly inventoried, qualified for the value drivers outlined in the business case, and appropriately fit to standard in the ERP available process menu. The future state of the new ERP environment does incorporate process improvements that inevitably cause some disruption. This issue can hinder adoption but can be minimized with a comprehensive change management and training when led principally by the stakeholder community.
Who qualifies is the ideal type of external vendor to facilitate an ERP implementation?
There is great difference between an ERP implementation firm that supports multiple verticals and a vendor that knows ERP for life sciences. Most implementation firms in the former category are technically sound and can support an out of the box solution with predefined templates. However, leading a transformation journey or optimizing an existing ERP instance requires a very unique aggregate of skills that most traditional implementation firms simply do not possess. The ideal leaders in the field are peopled with professionals that have years of experience directly in the client environments they serve, share similar customers and external stakeholders like the FDA/EMA. In addition, they should have multiple software relationships and a portfolio of client experiences that are singularly focused on life sciences.
Read the Latest at Kymanox
Analytical Techniques For Addressing Viral Vector Purification Challenges
When producing gene therapies, circular plasmids containing therapeutic DNA , an outer capsid shell, and proteins required for virus assembly are inserted into host cells. Manufacturers often face difficulties creating consistency in gene therapy produ...
Rapid Microbiologic Methods Aid In The “Race To Release” Challenges Of Cell And Gene Therapy Manufacturing
Rapid Microbiologic Methods (RMM) is perfectly suited to cell-based manufacturing because it allows scientists to obtain results up to ten times faster than traditional culture-based microbiological analysis techniques and with less produ...
Will The Real Critical Tasks Please Stand Up: How To Develop Your Human Factors Risk Assessment And Evaluate Critical Tasks
Human Factors Engineering (HFE) is a risk-based discipline crucial to validating that a medical product and its user interface is safe and effective for the intended users and use environments. The HFE process aims to optimize the user interface for me...