Services 2018-05-02T19:50:19+00:00

ValidPath possesses the flexibility to manage both large and small validation and commissioning projects. Our services encompass the broad spectrum of equipment and systems. ValidPath offers services in the following areas:

Automation

Biotechnology, Pharmaceutical and Medical Device companies are increasingly relying on “Smart” systems for control of the facility and its processes. ValidPath can assist you in demonstrating control of your control systems and compliance with 21 CFR Part 11.

• Distributed Control Systems (DCS)
• Programmable Logic Controllers (PLC)
• Building Automation Systems (BAS)
• Electronic Documentation Management Systems (EDMS)
• Electronic Batch Record Systems (EBRS)
• Packaging Systems (Robotics, Tableting, Vision)

Computer Systems Validation

As more and more regulated companies become increasingly dependent on the generation and storage of electronic data, demonstrating compliance with 21 CFR Part 11 for applications used in regulated activities is an absolute must. ValidPath conducts CSV based on principles of Good Automated Manufacturing Practices (GAMP) and the Software Development Life Cycle for the following types of systems:

• Analytical Instruments (HPLC, Mass Spectrometers, Luminometers, etc.)
• Lab Information Management Systems (LIMS)
• Validator 2000 and other Lab Data Acquisition Systems

Network Infrastructure Qualification

Generation and storage of electronic data is only as compliant and secure as the network on which it’s stored. Accordingly, the qualification of a regulated company’s IT network infrastructure is becoming a growing concern with the FDA. ValidPath can assist you in establishing a qualified network infrastructure that meets both your regulatory and business needs with the focus in the following areas:

• Network Architecture Evaluation
• Workstation Standardization
• Compliant Network Security
• Backup and Disaster Recovery Plans

Process Validation

After all the components of the process are qualified, the true challenge lies in bringing it all together and validating the whole. ValidPath can help you bridge all the components of your process and ensure that the whole is greater than the sum of its parts.

• Production Flow (including Solid, Semi-Solid and Liquid dose formulations)
• Lyophilization
• Clean-In-Place (CIP)/Clean-Out-of-Place (COP)
• Steam-In-Place/Sterilization
• Depyrogenation

Project Management

SCOPE IDENTIFICATION

ValidPath proposes services using a Risk-Based Approach. We will not propose testing or other services that are not “value-added”. For larger projects, we recommend conducting a Risk Assessment. The Risk Assessment activity is a highly effective tool that not only aids in prioritization of activities, but also yields a Gap Analysis that will identify any areas that may require extra focus.

PLANNING

The more effort spent planning in the beginning of a project typically nets a more efficient project. ValidPath strives to integrate the Lean Engineering approach wherever possible to minimize repeated testing and, more importantly, improve upon the schedule. By identifying areas of overlap in the Validation Master Plan, User Requirements, Design, Build, Commissioning, and Validation activities, the Project Team can realize significant gains against the schedule during project execution.

PROJECT TEAMS

Our successful track record highlights our understanding of how processes, facilities, and laboratories work. Our professionals quickly integrate into our clients’ operations reducing up-time to get the project running. Each team member is well-versed in quality and the level of detail necessary to get it right the first time.

PROJECT MANAGEMENT AND COMMUNICATIONS

Our Project Managers have several successfully completed projects under their belts and understand the fine balance needed when working with diverse project teams. We also make it a point to provide regular schedule and cost updates, which can be customized to the client’s needs for metrics reporting.

We can help you incorporate quality validation methodologies and products into the development process for easier scale-up and faster speed to market. Let us work with you to provide solutions that meet your business needs and optimize your validation and quality programs. Consistent quality can be cost-effective. Let ValidPath assist you in taking your compliance needs in the right direction.

CQV

COMMISSIONING, QUALIFICATION, AND VALIDATION

ValidPath offers FEU commissioning and qualification services tapered to your needs. Across the spectrum from the smallest GLP laboratory to a production-scale Sterile Fill/Finish Facility, there is not a “one-size-fits-all” approach to FEU qualification. We can work with you to determine your FEU requirements or operate within the framework of your validation program.

• FAT/SAT
• Commissioning
• IQ/OQ/PQ protocol generation and execution
• Retrospective Qualification
• Change Control