Computer System Validation (CSV) Capabilities
Kymanox experts have developed a suite of procedures and templates that accelerate our ability to implement a comprehensive CSV program within any life science organization.
01
On-Site and Off-Site Support
We perform gap and risk assessments of the software, infrastructure, and IT services your business relies on, whether on-site or off-site. We can also assess other quality system elements like training and SOPs.
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02
Quality Audits
Kymanox offers third-party supplier audits to evaluate the capabilities and quality systems of a prospective vendor, as well as response audits when there are concerns with the performance of a purchased product.
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03
Specialized Software Support
When you need specialized support, we can provide CSV support for graphics software used in devices and manufacturing, clinical databases and spreadsheet software, and cloud-based REMS applications.
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04
Documentation for CSV and Data Integrity
Kymanox has extensive experience in developing documentation to address 21 CFR Part 11 compliance and data integrity regulations.
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Kymanox Computer System Validation (CSV) Resources
Meet our Computer System Validation Solutions Experts
Jim Falanga
DIRECTOR, CSV COMPLIANCE
Helpful Links
Here are some of our favorite resources on this topic
Markets That Benefit from Our Computer System Validation Solutions
Drug 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 Computer System Validation (CSV) Solutions Difference
Kymanox has been an industry leader in CSV/Part 11 compliance for more than a decade
Industry Firsts
Kymanox was the first company to get a tablet application approved by the FDA for use in trauma surgery and one of the first involved in validating cloud-based applications used to make CGMP/GCP decisions.
Unmatched Track Record
Kymanox has validated over 100 major systems including patient portals for billion dollar drugs, electronic document systems, enterprise systems, and high-risk medical device software.
Efficient & Effective Solutions
Kymanox CSV templates and procedures are used around the globe! Our completed validation packages have been reviewed by countless external parties and regulatory bodies with no complaints or observations.
What Our Clients Have To Say About Kymanox
Frequently Asked ERP Questions (FAQs)
Does out-of-box software need to be validated?
There is no such thing as “out-of-box” for Life Sciences. Even if you do not customize functionality, software can be configurable. The risk is not out-of-box functionality, it is the configuration and adherence to the company’s process. Software implementation is about process, not software. Validation is required to establish documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality attributes.
What type of specialized software do you support?
Kymanox can provide CSV support for graphics software used in medical devices and CGMP manufacturing, clinical databases and spreadsheet software, and cloud-based REMS applications governing black-boxed FDA medications. We also offer guidance for laboratory instruments and automated manufacturing and utility equipment using DCS, SCADA, PLC, and HMI, as well as serialization systems per FDA Drug Supply Chain Security Act (DSCSA).
What is in scope of Computer System Validation?
A “Computer System” is the collection of software, hardware, and SOPs that are described in a set of approved specifications for a defined purpose. The manufacturer is responsible for defining the “system” through best practices which include well documented, manufacturer specific, User Requirements, Functional Requirements and SOPs that are approved by the system owner and quality assurance.
What systems does Kymanox have experience validating?
Kymanox has broad experience across many systems and software including SAP, Sage, MS Dynamics, JD Edwards, ASC, and other Enterprise Resource Planning (ERP) software, as well as Commercial Off-the-Shelf (COTS) and custom software including Laboratory Information Management Systems (LIMS), Electronic Document Management Systems (EDMS), Electronic Quality Management Systems (QMS), Building Management Systems (BMS), Environmental Monitoring Systems (EMS), and complaint handling and related pharmacovigilance reporting systems.
How can you help with 21 CFR Part 11 compliance?
Kymanox can provide expertise in developing the following documentation to address 21 CFR Part 11 compliance and data integrity regulations, including validation project plans (VPPs); Part 11, gap, and risk assessments; user requirements specifications (URS), software requirements specifications, and software design specifications. We also offer traceability analysis and design review; commissioning protocols, validation protocols (IQ/OQ/PQ), and final reports; and validation monitoring, exception reporting, and change control.
What type of standardized solutions do you offer?
Kyamnox offers Standard Operating Procedures (SOPs) to address the IT infrastructure including Data Backup, Data Security, Computer System Validation, and other aspects of computer systems that support electronic records and signatures, as well as Software as a Service (SaaS) hosted platform recommendations for uses in document control or business management, qualification, and development of SaaS infrastructure.
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