Compliance
PRODUCTS
-
Eliminate errors and accelerate production with MasterControl MES.
MasterControl Manufacturing Excellence is a modern manufacturing execution system (MES) that has helped hundreds of manufacturers eliminate millions of errors and deliver products to the market 70% faster.
It’s time to modernize your manufacturing operations – from digital work instructions and production records (EBR/eDHR) to electronic logbooks and equipment tracking – and see how MasterControl Manufacturing Excellence software can help you run faster, leaner, and smarter.
-
A Transfection Solution for Gram-Scale Protein Production
The ExPERT VLx system delivers unmatched transfection scalability with MaxCyte's Flow Electroporation® technology for industry-leading reproducibility, flexibility and ease of use.
- Reduce time, cost and risk
- Transfect up to 200 billion cells, in a single-use system, in less than 30 minutes
- Obtain grams of proteins in weeks, not months
- Achieve reproducible results, superior transfection efficiency, cell viability and protein expression
- Scale seamlessly to expedite your transition from discovery to Phase 1
- Proprietary Flow Electroporation® Technology
-
Ideal for field and environmental testing, the TB 350 turbidity meter delivers the most reliable measurements for low range to high range samples without sacrificing accuracy.
-
Did you define your manufacturing contamination control strategy, or is it a collection of changes over time?
-
The LabAlert™ wireless laboratory monitoring system is designed to provide secure, real-time oversight of critical lab equipment and environments. This cloud-based platform enables centralized monitoring of temperature, humidity, and CO₂ levels across single or multiple facilities, with customizable alerts delivered via web or mobile app. The system supports FDA 21 CFR Part 11 compliance and eliminates manual data logging with secure, centralized recordkeeping. Easy to install and scalable, LabAlert also includes tools for preventative maintenance tracking and cost management.
WHITE PAPERS AND CASE STUDIES
-
Delivering Apheresis Treatment From The USA To The UK Within 24 Hours
The goal was to perform next-day collection of temperature-sensitive tumor material for an urgent patient treatment. A flexible mitigation strategy was essential to manage short turnaround.
-
Allos Faced A Diverse Set Of Business Challenges Allos Therapeutics, Inc. is a biopharmaceutical company focused on developing and commercializing innovative small molecule therapeutics for the treatment of cancer. Allos has 75 employees in offices in Colorado and New Jersey. Especially with distributed employees, a paper-based system was not meeting the company’s needs for information sharing and collaboration. By KnowledgeTree, Inc.
-
Successfully Delivering Critical Stem Cell Samples Across The Globe
To deliver multi-leg shipments of crucial stem cell samples on-time and within specifications, samples had to be collected from Japanese apheresis treatment centers and transported to a USA manufacturing plant within 24 hours.
-
How To Survive An FDA Audit
Understanding the FDA audit process, preparing for it and being aware of regulations will help to restore a sense of control and help to ensure the best outcome.
-
DeKalb Medical Center Secures Patient Data With Proofpoint As a medical center, DeKalb Medical Center is very sensitive about patient privacy. Recently, the organization conducted an audit of its data security and determined that outbound email was a high-risk area for protected health information (PHI) to leave the enterprise. As a first step, the medical center needed to secure its outbound email stream to ensure that PHI was not being sent out unencrypted. By Proofpoint
-
A Step-by-Step Guide to Implementing An Effective Track-And-Trace Program
Although a universal standard for pharmaceutical track-and-trace solutions has yet to emerge, the California Board of Pharmacy’s ePedigree requirements are currently driving action in efforts toward implementing serialization to provide supply-chain integrity to the public. At Aphena Pharma Solutions, we have developed a step-by-step process that has helped us establish a very effective track-and-trace program.
-
Data Integrity - Understanding And Becoming Compliant With GMP FDA Regulations
Data integrity means data (such as from personnel or environmental monitoring) that is accurate, complete and repeatable, which in turn ensures the product's quality and public safety. In recent years, infractions relating to data integrity have been noted in several Food and Drug Administration (FDA) warning letters, but it is not a new concept. Understanding recent standards, guides and regulations pertaining to data integrity is essential to becoming compliant.
-
Support Manufacturing Operations With Process Data Management Software
Learn how process data management software automated data acquisition for clinical-stage allogeneic CAR T and in vivo gene therapy developer Precision BioSciences (NASDAQ: DTIL).
-
AIIM Eyes Records Management In Government And Beyond At a recent advisory board meeting for ECM (enterprise content management) trade association AIIM, the hot, compliance-driven topic was electronic records management. Written by Tom von Gunden, Chief Editor
-
Overcoming Obstacles To Deliver Critical Autologous Cell Therapy
See how teams ensured a seamless route, including on-time customs clearance and delivery of autologous cell therapy, from the U.S. to a manufacturing site in Germany
-
Malware Creativity Means VAR Opportunities To highlight the market opportunities for VARs, PC Tools released the findings from a worldwide survey of more than 25,000 respondents — of which 12,307 were from the United States. By Business Solutions magazine
-
Electronic Informed Consent: Considerations For Implementation In Clinical Trials
In an era where data acquisition (eg. ePRO), capture (EDC) and storage (eTMF) are done electronically, it is the logical consequence to do the same for the informed consent process as all the advantages of the electronic modality equally apply to this process.
NEWS
-
NLMJ Technologies LLC Partners With ELD Mandate To Deliver ELD, HOS, GPS Fleet Tracking & AI Dashcam Solutions7/7/2025
NLMJ Technologies LLC, a Dallas-based innovator in fleet management technology, is proud to announce a strategic partnership with ELD Mandate, a nationally recognized provider of FMCSA-compliant electronic logging devices (ELDs) and GPS tracking systems.
-
SwiftComply Launches Next-Gen Pretreatment Module, Setting A New Standard For Water Compliance6/18/2025
SwiftComply, the software platform built specifically for water utility compliance, today announced the launch of its new Pretreatment module, a specialized, smart system for managing industrial wastewater oversight.
-
Rohde & Schwarz Launches High-Flexibility EMI Test Receivers At EMV2025 Paving The Way For Optimized Investments3/20/2025
The new EMI test receivers R&S EPL1001 up to 1 GHz and R&S EPL1007 up to 7.125 GHz offer engineers a flexible and cost-effective solution for EMI measurements.
-
Evonik Coating Additives Launches First Mass Balanced Products For Coatings And Inks3/12/2025
Evonik Coating Additives introduces its first two mass balanced products, TEGO Wet 270 eCO and TEGO Foamex 812 eCO, providing coating and ink formulators with the same high-performing defoamer and wetting agent properties they expect, but with a reduced carbon footprint.
-
Thermal Flow Meter Improves Natural Gas Pipeline Booster Station Flare Unit Monitoring8/18/2025
Engineers responsible for natural gas pipeline booster compressor stations will want to learn more about how the ST100A Series Thermal Flow Meter from Fluid Components International (FCI) offers them highly accurate and repeatable gas flow measurement in hazardous areas to assist in compliance with environmental mandates.