Development and Lifecycle Management of Software as a Medical Device
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We have been providing commissioning, qualification, and validation (CQV) services to our clients for over 18 years. Our dedicated CQV professionals bring wide-and-deep knowledge of the entire validation lifecycle (VLC), having supported clients from all major sectors within the Life Sciences industry. We guide you in the selection of the right validation strategy and fully supports all your tactical, hands-on deliverables, from protocol preparation, through “floor executions” and data analysis. We have the capability of implementing these through various types of service delivery models which include:
- Full project model – we create high-performance teams (HPT) to deliver end-to-end solutions (e.g. from project management to the specific CQV deliverables, including creation of forecast and service demand tools, and KPI selection and monitoring)
- Staff augmentation model – we match your specific CQV need with any number of resources from our pool of CQV engineers and scientists, while staying connected with both our resources and clients to monitor progress and assure project success
- Hybrid models – we have successfully engaged in hybrid models by inserting both high-performance teams (HPT) and specific resources within various workstreams of a larger project. We stay flexible from the beginning to the end of the project to build trust and create a true PharmaLex Partnership
Our CQV services include:
- Commissioning and Qualification (C&Q)
- Product-Processes Validations and Maintenance of The Validated State
- Strategic and Support Services
Our C&Q engineers have extensive experience partnering with your construction company and applying Good Engineering Practices (GEP) for successful commissioning projects. Our C&Q engineers also possess the required attention to details, and knowledge/mindset in cGMPs and GLP to successfully execute the qualification of your manufacturing and laboratory facilities and equipment, your utilities, and your systems, following both the traditional and leverage approaches to C&Q.
Our services include:
- Preparation of the early validation lifecycle deliverables, from the user requirement specifications (URS) to the design qualification (DQ) documents
- Preparation and execution of commissioning testing protocols (e.g. factory acceptance tests, site acceptance tests, installation verification, etc.)
- Guidance and preparation of Quality Risk Assessments for the execution of “enhanced commissioning” strategies
- Preparation and execution of validation plans, and installation and operational qualification (IOQ) protocols; preparation of validation summary reports
- Assessment of commissioning data and preparation of leveraged IOQ reports
- Preparation and execution of Computer System Validation (CSV) and Software Validation protocols; preparation of summary reports
- Qualification of Laboratory Equipment and Instrumentation
- Data Integrity Assessments
When the equipment meets the product, the focus is now on processes. Our validation scientists and engineers have extensive experience validating all types of processes: manufacturing processes (PPQ), cleaning processes (Cleaning Validation), sterilization and decontamination processes (sterilization PQ), and aseptic processes (media fills).
Trained to actively seek process understanding, our validation professionals proactively identify and fully understand the critical process parameters (CPP), critical quality attributes (CQA), and their interrelationships for every process being validated. This fundamental, science-based mindset is equally applied to the validation of analytical methods (Method Validation), packaging process (Packaging Validation) and the areas governed by Good Distribution Practices (GDP) such as warehouse (temperature and humidity mapping) and transportation processes (transport qualification).
Once all processes along the product supply chain have been validated, we support our clients in their quest to maintain The Validated State. Our validation professionals fully understand the expectations for continuous and continued verification set by the FDA, EMA, and regulatory bodies around the world. We establish validation maintenance strategies in accordance with such expectations, and execute re-qualifications as needed.
Our services include:
- Characterization and validation of sterilization and decontamination processes
- Steam sterilization in autoclaves and stopper processors
- Qualification of steam-in-place (SIP) systems
- Qualification of depyrogenation processes
- Validation of vaporized hydrogen peroxide (VHP) decontamination processes
- Validation of e-Beam decontamination processes
- Validation of ethylene oxide and gamma irradiation processes
- Cleaning process characterization and validation
- Calculation of equipment surface areas
- Calculation of Cleaning Validation limits and establishment of acceptance criteria
- Cleaning characterization/validation execution and data analysis
- Method Validation (MV) for analytical, microbiological, and biochemical laboratory test methods
- Process Validation (PPQ) for
- Drug Substance (DS) Manufacturing Unit Operations
- Organic synthesis processes (small molecules)
- Biotechnology processes (large molecules)
- Drug Product (DP) Manufacturing Unit Operations
- Oral Solid Dosages (OSD)
- Parenteral products and aseptic process simulations
- Lyophilization processes
- Medical Device Manufacturing
- Process Engineering support
- Quality Engineering support
- Cell and Gene Therapy Processes
- Drug Substance (DS) Manufacturing Unit Operations
- Inspection and Packaging Processes
- Support to visual inspection program for parenteral products (e.g. defect library design and creation of test kits, conducting Knapp studies, visual inspector qualification)
- Serialization project support
- Packaging Validation
- GDP-related Validations
- Warehouse mapping
- Transport Qualification (TQ)
- Validation Maintenance
- Periodic (time-driven) requalification for critical processes
- Periodic Review program and execution
- Validation assessments for change controls
Successful CQV projects require not only the right expertise from the right professionals at the execution level, but also optimum validation strategies, skillful project management, and in-depth knowledge of the regulatory compliance aspects of the validation workstreams within a new product introduction or technology transfer project. We provide the full spectrum of services at the core and at the periphery of your CQV projects. These include:
- Project Management (PM)
- New Product Introduction (NPI) and Technology Transfer (TT)
- Validation approaches and strategies (e.g. bracketing, matrix, worst-case), documented in
- Validation Master Plans (VMP)
- Validation Policies, Procedures, and Guidelines
- Quality and Regulatory Compliance Support
- QA review of validation documents
- Validation-related investigations and validation impact assessments
- PAI readiness, audit support, and gap assessments
- Training on the entire Validation Lifecycle (VLC)
- Overview of the Validation Lifecycle (VLC)
- Trainings and workshops specific for each type of CQV service provided, including customized training following our client procedures
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What our clients say
In these unprecedented times, PharmaLex continues to support all clients by meeting virtually and providing experienced, remote-based consultants.
Thomas Dobmeyer, CEO PharmaLex
CEO PharmaLex
CEO PharmaLex
There was a close relationship between the regulatory strategy and the writing activities. You developed a fine-tuned regulatory strategy which will be a key factor to smooth the approval of our dossier.
Large Pharma, Global
VP Regulatory Strategy
VP Regulatory Strategy
