Our Services
Capacity and experience to efficiently, feasibly and reliably manage the projects and operations of our clients.
We create value and profitability.
We separately resolve each project that is part of the whole process, which leads to a successful result.
Audits and improvement plans
Forprocesses, Systems and plants. Assessment of compliance with GMP (FDA, EMEA, ANMAT, ANVISA, INVIMA and others).
01- Project Audits
- Compliance and follow-up audits
- Gap analysis part 11
- Improvement plans
- Follow-up of current, on-going plans
- Process improvement
Architectural and engineering projects
Support and project management. From the planning to the delivery of work, were main with your project.
02- Pre-constructionmanagement
- Planning, construction, work supervision
- Quality assurance, cost, equipment acquisition
- Start-up of work and projects
Procedures Development
Development, design, implementation and supervision.
03- Development of procedures for: systems, areas, equipment and maintenance
- HVAC Sytems: development, design, implementation, electrical installation, calibration, start-up
Automation and programming
Every automation requirement is unique and so are our solutions. We have the ability and knowledge to create programs from scratch and to modify and extend existing ones.
04- Automation Project Management
- Commissioning of automated systems
- PLC Programming Systems
- SCADA Programming Systems
- Development and execution of automated processes and computerized systems protocols (validation plans/IQ/OQ/CSV/PQ and reports)
Process Control Improvements
Implementation of improvements to achieve more effective results. Troubleshooting and optimization towards efficiency.
05- Process control improvements
- Audits and assessment GAMP5
- Plant Control Systems Support (problem solving, emergency calls)
Business Consulting
With international experience in law and business, we provide consultation services regarding the decisions and paperwork required to complete the project.
06- Analysis, mediation and viability studies for the purchase and sale of establishments, products, and/or equipment between different countries
- Registration of products in different countries under local regulations
- Negotiation and mediation between parties
- Facilitate registration and/or patent services in the US market
- Preparation and submission of “Interim New DrugApplications (IND), New Drug Applications (NDAs), and supplemental New Drug Applications (sNDAs)”
- Continuity plans
Transfer of products and technology
Implementation and improvement. Troubleshooting and optimization toward efficiency. We provide the necessary support with the appropriate knowledge to comply with all requirements.
07- Assessment before a product or technology transfer
- Support in the preparation of transfer documents
- Troubleshooting during manufacturing
- Investigations
- Cleaning procedures
- Design and area classification
- Selection of equipment and systems design
Validations
Experience and track record in validation, qualifications and certifications.
- - Validation Master Plans (VMP)
- Design Qualification (DQ)
- Installations Qualification (IQ)
- Operations Qualification (OQ)
- Performance Qualification (PQ)
- Cleaning Validation (CV)
- Process Validation (PV)
- Computerized Systems Validation (CSV)
- CFR Part 11 Compliance
- Area filters and Equipment Certification
- FAT/SAT
- Traceability matrix
- GAP Analysis
Automation software
Maintenance and support to keep your software up-to-date. Design Specifications and analysis of requirements.
- Change Control Management
- Back up and data storage
- Periodic system reviews
- Software upgrades
- Customized Solutions for 21 CFR Part 11 compliance
- Development and execution of FAT/SAT documents
- Functional Requirements
- User Requirements
- Code Analysis of PLC software
- Subcontractor Management
- Development of Standard Operating Procederes for automated systems
Trainings
Adaptable to client needs and different types of audiences: management, intermediate and operational levels.
- GMP/GLP
- Validations
- Smart Phone Apps Development
- 21 CFR parte 11
- Processes
- Equipment handling and operation
- Audits
- Negotiation
- Management
- Industrial security
- Occupational health
- Training and seminars in automated processes and equipment
Pharcom Solutions :: Rystone
If you have a project to execute, count on our expertise and experience to help you accomplish your goals.
