Computer System Validation

MMR offers custom risk based approach to Computer System Validation (CSV). Our CSV experts has experience in creating and executing CSV deliverables for various systems including ERP, LIMS, eQMS, MES, process equipment and many others.

CSV Expertise

Cloud based application: (SaaS, PaaS, IaaS)
Configured Off the Shelf (COTS) packages
Custom build systems and applications
Automation Validation: Process Controls (PLCs, DCS, GE Unicorn / Cytiva), BAS Systems (Johnson Controls, Siemens, Honeywell)

Systems Validated

Adverse even management system: Oracle Argus Safety
Enterprise Requirements Planning Systems: SAP, Acumatica, Dynamics 365 and Sage
Desktop Applications: Excel spreadsheets, SharePoint sites
Digital Signature: AdobeSign, DocuSign
Quality Management Systems: TrackWise, MasterControl
Validation Management system: Kneat, HP ALM
Manufacturing Control Software: PartMaker, PLCs, DCS (DeltaV, Siemens PS7), GE Unicorn / Cytiva)
BAS Systems Validation: Johnson Controls, Siemens, Honeywell
Manufacturing Execution Systems: Werum Pas-X, Siemens EBR, Historian Systems, OSI-Pi
Pharmacovigilance Systems: Oracle Argus

Implementation of CSV Program

Provide CSV SOP development such as Risk-based Validation, Change Control, Incident Management, Periodic Review, GxP assessment including appropriate staff training.
CSV templates such as, Validation Plan, User Requirement, Test Protocols and Validation Report
Evaluate and assess current procedures and practices vs regulations and industry best practices
Address compliance gaps by updating current procedure
Implement risk based methodologies and address inefficiencies

KneatGx™ Paperless Validation

As a Kneat Services Partner, we’re completely qualified to map and configure your work processes to KneatGx™
Learn more about the KneatGx™ services we provide

Check out some of our publications on the CSV services we provide.

Working from Home – Our New Reality

Pharmaceutical company professionals understand the necessity of maintaining schedules and deadlines. In response to the pandemic of 2020, many technologically sophisticated businesses’ IT support teams have deployed the software tools to keep us integrated with our professional communities while observing the new work from home or quarantine limitations being imposed on the workforce. This is
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For any inquiries of our services or previous work, please contact us.

Fujifilm Diosynth Biotechnologies has utilized MMR Engineering at our two US Manufacturing facilities in North Carolina and Texas due to their expertise in Cytiva’s proprietary Unicorn software and Emerson’s DeltaV platform. MMR Engineering was prompt in delivering their proposal, accepting the awarded project and mobilizing their staff on site. Their personnel worked efficiently and strategically within our Automation, Quality Assurance and Validation Departments to deliver a qualified processing system on time and within budget. Their executed protocols were done right the first time all while meeting our stringent cGMP requirements such as adherence to SOPs and training, obtaining access to numerous qualified, electronic systems and supporting change control. MMR Engineering continues to provide Validation and Automation support to both sites at the present time and in the foreseeable future.

Charles Crosier

Sr. Project Manager/Principal Engineer, Fujifilm Diosynth BIotechnologies

MMR’s team has shown great expertise in Clean Utilities when delivering a Global Engineering Guidance project for AbbVie on high purity water systems. Their persistence to meet timelines and deliver projects within tight schedules is also unique. MMR’s technical aptitude and project delivery was instrumental to the successful delivery of our projects, I would highly recommend MMR for Clean Utilities engineering projects.

Chris Peterson

Senior Process Engineer - Clean Utilities, AbbVie

MMR Consulting has demonstrated a profound technical knowledge in clean utilities and other process support systems / utilities, as well as a very unique project delivery model. Their creativity to figure out the real problem and determine a practical solution within a client’s constraints, as well as deliver a project within tight timelines and variable expectations, coped with their technical knowledge, engineering and commissioning skills makes them an exceptional consulting partner. I am fortunate to have worked with MMR on several projects, and would highly recommend them for either technical staff augmentation, or design and commissioning projects, with a specializing in Clean Utilities and Process.

James Meils

Manager Critical Systems Projects, CSL Behring

MMR was contracted to support two high priority projects within our Toronto manufacturing facility: one focusing on chromatography skid upgrades and another on CIP process improvements.

MMR’s management of the two system upgrades was achieved in 9 months, from inception to completion. Further, the actual execution of engineering and IOQ was done during a shutdown period within 6 weeks. The CIP systems were turned over on time without impacting production.

Patrick Bunker

Deputy Director, Engineering Project Management, Sanofi Pasteur