Solutions for Pharmaceutical & Biotech Companies
FDA Compliance & Validation solutions and Laboratory Equipment Support Services
Compliance & Validation
Laboratory Equipment Support
FDA Compliance & Validation ServicesOperational Compliance and Risk Management for Pharmaceutical Companies
The most effective validation projects are based on a thorough understanding of risk. Quantitatively analyzing each process parameter for criticality leads to better specifications, targeted validation testing, optimized processes, and ultimately, reduced costs. Let CSA develop risk management solutions that optimize your validation program.
There are many interpretations of process validation, but most experts view it as the final step in the process development cycle that ensures production is accurate and consistent over time.CSA provides a modified approach that uses risk management to analyze the process as a whole rather than a collection of discrete pieces. Once the risks are understood, this data can be used to remove redundancies and justify reducing tests that are of little value. After all, a process is the confluence of equipment, materials, facilities, computer systems and people which must work together to achieve the goal of production. Our engineers work with your team to understand and document each step of the process in order to provide an approach for FDA compliance suitable to your needs. From this understanding, we can also offer suggestions for process analytical techniques and monitoring for even greater control.
Computer System Validation
Computer systems are a critical part of modern operational processes. But despite their ubiquity, many systems must be uniquely designed or configured to meet the specific needs of a business. When deployed in a GMP environment, these unique characteristics can be a challenge to validate in a manner that is both FDA compliant and efficient. Given the high cost of software, hardware and deployment, no one wants to spend even more time and money than necessary on a lengthy validation project. Validation testing should provide more value than just a collection of screen shots. Since one size doesn’t fit all when it comes to operational compliance, we employ risk management and process analysis techniques to tailor the validation effort specifically to your business. These powerful techniques maximize the value of FDA mandated computer system validation by identifying critical steps and functions, and focusing tests on what really matters to your process.
We offer a wide range of automation services including technical support, consulting, training, commissioning, start-up and turnkey control system solutions. Our staff is experienced with both process and discrete controls from a variety of DCS, PLC, and HMI vendors including ESD/SIS systems. We work closely with your team from start to finish ensuring the goals of the project are well defined and successfully met. Our engineers are well-versed in GMP and GAMP requirements for automated systems and can save you time and money by adequately addressing potential validation issues during the design, integration and support of automated control projects. Our engineering staff is very knowledgeable in many areas of industry including process analytical technology (PAT), vision systems, RFID, enterprise data management and new software platforms. Let us help you realize lower operating costs by improving process efficiency and optimizing your equipment.
A number of current issues, including increases in drug potency and the expansion of contract manufacturing, have led cleaning processes to receive heightened scrutiny from the FDA. Cleaning validation studies are even more important when it isn’t feasible to use dedicated equipment for a given process or product. But how clean is lean enough? And how much sampling is needed to demonstrate cleanliness? These are not easy questions to answer, even for process experts. Our engineering and science professionals understand the criticality of cleaning processes and through careful design and analysis can help you ensure the effectiveness of yours. We provide expert guidance in establishing validation test protocols, setting residue and cleanliness acceptance criteria, developing sampling plans and working with either your laboratory or a third party to ensure test methodology is adequately sensitive and accurate.
While equipment qualification is generally understood, it isn’t always easy or efficient. In fact, it is frequently cited in FDA inspection 483s and warning letters. We offer equipment qualification services that maximize efficiency while ensuring compliance with the FDA‘s expectations for validation. By focusing equipment validation testing on intended usage and combining it with other validation tasks such as commissioning and controls, we can significantly improve efficiency and reduce the validation timeline. Our staff has the applied industry experience and technical background to define equipment requirements, develop and execute test protocols and tie equipment compliance into the scope of your process validation requirements. We provide a wide range of equipment qualification services that satisfy the FDA’s expectations for equipment and facility compliance. We support new and legacy equipment and work closely with your team to ensure equipment is designed and installed according to your specific process requirements.
Types of Equipment and Systems We Support
Laboratory Equipment Support ServicesMulti-Vendor Repair and Maintenance of Laboratory Instruments & Equipment
More testing, less time and fewer resources. Laboratories are constantly asked to do more with less while increasing throughput and maintaining quality compliance. Equipment service can be expensive, but neglecting it can be even more so. When instruments don't meet specifications or fail altogether, service costs and lost labor add up quickly.
Simple Fixed Fee Services
Not all equipment requires a service contract. For those that want to maintain control of their service program and order support on a caseby-case basis, CSA provides simple fixed fee services with no obligation beyond the service visit. This model is ideal for labs that:
Service Contract Assurance
Ensure that your instrumentation receives the regular service it requires and the rapid response you need when it fails. CSA offers service contracts for many instruments at a significant discount to the OEM. Our contracts are customized to give your laboratory exactly what you need, when you need it. All of our services include parts, standards and test equipment to keep your equipment in optimal condition. Our standard service package can include:
For laboratories with a wide array of instruments and equipment requiring rapid support, CSA offers full-time onsite services. We can place an engineer in your facility to keep scheduled services on track while providing the most rapid response possible for repairs or unexpected needs.
Laboratory Services for Most Brands and Models
CSA offers best-in-class multi-vendor services that ensure your instrumentation is ready when you need it at a fraction of the cost of a manufacturer’s service contract. Our comprehensive laboratory services ensure reliability and regulatory compliance across a wide range of instrumentation and equipment from most major vendors.
CSA Equipment and Instrument Services for Your Laboratory Include:
Preventative Maintenance (PM)
Service contracts include an annual preventative maintenance visit, and additional PMs can be added for more frequent service to keep your equipment running in optimal condition. PM services are also offered independently without a contract.
Repair and Maintenance
Our local field engineers provide rapid onsite response for corrective maintenance as part of all field service contracts. Response times vary from 24 – 72 hours depending on your geography and contract type.
Installation, Operational and Performance Qualification (IQ/OQ/PQ) is offered as a stand-alone service or as a part of our Life Science Full Coverage Assurance service contract. Our IQ/OQ/PQ (sometimes called OQ/PV) services conform to standard industry practices and the FDA’s current thinking for GMP compliance.
Field calibration services are provided for temperature, humidity, CO2, mass, time, pressure, flow and volume measurements. Services are thoroughly documented and include all certifications and pertinent records.