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IT Validation for Pharmaceutical Enterprises
Pharmaceutical enterprises need to simultaneously deal with financial challenges and tight deadlines due to the fierce competition in the market, extremely strict quality requirements and the expectations of the authorities (Food and Drug Administration [FDA], National Institute of Pharmacy and Nutrition [OGYÉI], etc.) continuously enforcing these requirements.
Com-Forth helps to meet these challenges by offering reference materials, consultations and even validation services.
We offer comprehensive validation packages in line with the applicable Hungarian and international standards and the recommendations of different organizations.
With regard to the current and future trends of pharmaceutical validation, our validation activities increasingly rely on the Software Development Life Cycle (SDLC) and Quality by Design approaches. We provide support for our customers from the moment of defining the requirement through system planning, execution and operation up to the optional cancellation, with integration into our own or into the customer’s quality assurance system.
You can rely on us in the following fields:
Planning
- Compile User Requirement Specification (URS)
- System specifications (FS, SDS, HDS)
- Risk assessment and management (RA)
Implementation
- Development
- System integration
- Other expert services
Supervision
- Compile Validation Plan (VP)
- Compile Design Qualification (DQ)
- Tracking and Monitoring (TM)
Testing
IQ, OQ, PQ, SCR, etc.
Overview, reporting
VR, SAR
Operation
Com-Forth has considerable experience in the field of pharmaceuticals with a large number of references. Our validation activities are based on our system integration, pharmaceutical industry related and validation experience – we are aware of the different aspects of technology and quality assurance and act in line with these. This is why our activity is truly unique in the Hungarian market and fills a gap.
Besides our proprietary systems and the software products distributed by us, we also offer validation services for other existing, legacy or third-party systems.
Validation requirements are a considerable challenge for pharmaceutical companies involving production losses, operative resource reallocation, and logistics issues. Moreover, there is the cost implication of maintaining a team that has the up-to-date technological, technical and quality assurance expertise necessary to carry out execution and management tasks. It is not easy to rationally execute these tasks without financial efficiency and a direct financial gain. Consequently, in many cases the viable alternative is to involve a contractor so that costs are based on the work done and the services provided only. Our scalable, customized validation packages cover all the potential requirements of our clients including the assembly, creation, or execution of validation documentation, or just training and consultancy.
What are the benefits of using a validation service provider?
- Execution does not use the internal resources of production, engineering or quality assurance
- Easier to organize and schedule
- Saves the cost of keeping the professional knowledge constantly up-to-date
- Easily scalable, costs are based on the size of the actual project
- Maximum transparency and predictability from a financial perspective
What are the benefits of using Com-Forth as your validation service provider?
- 30+ years of experience in the industry, and a very high number of successful projects
- We use a combined approach of system integration, pharmaceutical industry and quality assurance experience
- Thorough knowledge of Hungarian and international requirements
- Validation of legacy and third-party systems
- We can handle scenarios that others cannot (legacy systems, lack of documentation, etc.)
- Fully flexible: custom validation packages tailored to individual needs
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Tamás Hóringer joined our team in January 2015 with decades of experience in the fields of security technology and weak current engineering, as well as four years of experience in pharmaceutical production. He is our HMI/SCADA specialist, who knows all iFIX versions, licensing, the tricks as well as the nuts and bolts. He is also an expert in IT validation and famously eager to take on tricky projects – and to write popular blog posts about his experience.
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