Effective Quality Risk Management (QRM) is key to product quality and

performance excellence. Both are stra-tegic priorities that can only be attained

and then sustained via comprehensive assessments using data, process and operations

experience, CAPA, and verification.

With decades spent in commercial GMP Innovator/ CMO Operations, alliancebio executes and manages

3rd-party QRM life-cycle initiatives via Manufacturing System Assessments (MSA), Root Cause Analysis (RCA)/

CAPA, remediation project management, and prudent follow-up to assess effectiveness.

MANUFACTURING SYSTEM ASSESSMENT• Operational & Engineering Systems Assessment

• Technical Audits: Process, Equipment, & Facility• Design Review: Process, Equipment, & Facility

RCA/CAPA DEVELOPMENT• Investigation Team Development & Management

• Root Cause Data Collection• FMEA / HACCP Development

• Root cause and CAPA Identification

PROJECT EXECUTION & MANAGEMENT• Translate CAPA Solution to Project Scope and Execution Plan

• Project Management for CAPA Implementation• CAPA to Operations Plans

TECHNICAL SUPPORT SERVICES• CMO Due-Diligence: Process Fit, Operational Capability

• Type C Meeting Support

WASHINGTON, D.C. METRO AREA www.alliancebio.us

QUALITY SERVICES

PROJECT MANAGEMENT• Automation design review

• Development/Review of system life-cycle documents

• System architecture development• Commissioning and validation support

• Integration services for building management, DCS and PLC systems

• Startup of systems, equipment and facilities• Operator and technician training of control system use and maintenance

SYSTEM INTEGRATION• Allen-Bradley PLC, SLC and Logix Systems

• RSView, FactoryTalk and PanelView HMIs• Emerson DeltaV and Provox

• Wonderware InTouch, System Platform and Historian• GE iFix, iHistorian and Unicorn

• Siemens APOGEE and Insight• OSI PI

SUBJECT MATTER EXPERTISEWe provide subject matter expertise in process control, instrumentation,

PLC and distributed control system platforms, and automation of upstream and downstream bio-pharmaceutical operations.

ALARM AND DATA MANAGEMENTWe assist clients with design, planning, implementation and validation of alarm

and data management systems, including process data collection, trending, report-ing and analysis. We can also assist with an alarm review to ensure that nuisance

alarms are minimized and operators only see what’s necessary.

REGULATORY COMPLIANCEThe alliancebio team has significant experience supporting GMP facilities, and can perform

gap assessments and risk analyses to ensure clients maintain compliance with GxP and FDA regulations including adherence to 21 CFR Part 11. We provide security evaluations to ensure

that clients’ automation systems and networks are protected, and assist with mitigation of risks identified.

TECHNOLOGY ASSESSMENTSHave questions about implementing wireless networks and instrumentation,

single use technologies, Industrial Internet of Things (IIoT), virtual computing environments, OEE or electronic batch records. Let alliancebio assist with those

assessments and generation of a cost/benefit analysis or ROI justification.

DISASTER RECOVERYalliancebio can assist with Disaster Recovery evaluations and the generation of

recovery plans and procedures to ensure the reduction of unplanned downtime.

The team at alliancebio provides Process Control and Automation Services to clinical and commercial clients in the life science industry. We provide the expertise needed for our clients to execute successful projects, and help them meet the demanding requirements facing the industry. alliancebio specializes in project management, control system design and integration, validation and support.

PROCESS CONTROLS & AUTOMATION SERVICES

WASHINGTON, D.C. METRO AREA www.alliancebio.us

BIOPROCESS SERVICES

PROJECT INITIATION• Business Justification; Executive-Level

• Facility Feasibility Studies and Estimates• Conceptual Design Support

BIOPROCESS TECHNICAL SERVICES

• Bioprocess Vendor Qualification / Award• Process Elucidation / Risk Assessment

• Process Flow Diagram / Mass Balances• Process Time-Motion

• Flow Drawings: Personnel, Material, Waste• Detailed Design Support

• FAT/SAT/Qualification Support• Biosafety Risk Assessments

• Type C Meeting Support• BDS/Aseptic Fill Facility Audits

• Con’t Improvement: Facility Upgrades

BIOPHARM OPERATIONS• Master Hiring Plans

• SOP/BR Generation and Review• Equipment Training

• Facility Utilization: Insource business model• 2nd Site / CMO / Supplier Due-Diligence

• BDS/Aseptic Fill Facility Audits• CAPA Remediation

UNIT OPERATION EXPERIENCE• Scale (L); 50 - 20,000

• Mode: Fed-batch, Perfusion (ATF/TTF)• Host: Mammalian, Insect, Bacterial

• NME: AAV/LV, mAb, cytokine, enzyme• Biosafety: BSL1, 2, 2+

Commercialization of biotechnology processes, driven primarily by target

product profiles (TPP) and characterization, require subject matter expertise spanning

conceptual design, commercialization, and continuous improvement. Expertise at all

stages properly informs and aligns key stake-holders, enabling fact-based assessments and

transitions to subsequent project phases.

WASHINGTON, D.C. METRO AREA www.alliancebio.us

alliancebio’s Owner’s Representatives act as project managers for the client from conceptual design through construction and operational readiness.

OWNER PROJECT & CONSTRUCTION MANAGEMENT

OWNER’S PROJECT MANAGEMENT• Scope Development

• Schedule Development, Management & Reporting • Budget Generation & Management

• Resource Planning• Project Controls & Reporting

ENGINEERING MANAGEMENT

• Design Approach & Strategy• Pre-Qualification

• Request for Proposal (RFP) Generation• Technical Bid Review

• Design Management• Design Review

• Equipment Acceptance Testing

OWNER’S CONSTRUCTION MANAGEMENT• Constructability Planning

• Pre-Qualification• Scope & RFP Development

• Bid Reviews• Management of CM & Trade Services

OPERATIONAL READINESS• Operational Plan Development

• Commissioning Planning, Management & Execution• Qualification Planning & Management

• Generation of Maintenance Plans, SOPs, Spare Parts• Training Development & Support

WASHINGTON, D.C. METRO AREA www.alliancebio.us