COMPUTER SYSTEM VALIDATION
Computer Software Validation is a formalized, documented process for testing computer software and systems, required by 21 CFR 11.10(a) and Annex 11, Section 4. The FDA and other regulatory bodies require validation to demonstrate that computer systems are in compliance with all regulations for electronic data management systems. Failure to validate systems is one of the leading reasons a business is issued a 483.
CP can validate all of your software, databases, spreadsheets, and computer systems, and develop the appropriate documentation for all phases of the software life cycle. We have written (and executed) commercially available validation packages. We can provide any level of service required, from executing test scripts generated from your existing specifications to writing the entire validation package. CP will follow your existing validation procedures or provide your company with validation standards. Our validation methodology ensures validation deliverables that are in line with industry standards and best practices, focus resources towards the most critical system functions, and complete the validation projects efficiently.
PART 11 & COMPLIANCE ASSESSMENTS
As the FDA increases regulatory enforcement of 21 CFR 11, one of the most difficult things for many companies is to know what technological and procedural controls their computer systems require in order to be in compliance. Ofni Systems can quickly assess all of your software, databases, and computer systems and identify what issues need to be addressed for compliance.
CP helps companies identify issues with their electronic systems. Our assessment professionals will take the time to learn your policies and review your software and procedures. We will provide you with a full documented risk assessment report for each system and, if necessary, develop a remediation plan that will work within your corporate culture. CP can also provide your employees with the training to remain in compliance with all applicable regulations.
Cleaning validation is just as important as process validation when it comes to the safety and continued compliance of any manufacturing firm. CP has the experience and knowledge to help our clients develop and verify that their manufacturing equipment consistently removes process soils before the next manufacturing run to ensure clean, uncontaminated equipment.
Our highly trained staff is experienced in developing and executing cleaning development and cleaning validation master plans and protocols in line with current industry standards. We provide a hands-on approach to help guide our clients through the details of establishing a cleaning master plan, setting residue acceptance criteria, preparing a comprehensive sampling plan, and validating and utilizing appropriate qualified analytical methods with sufficient sensitivity for those unique processes and equipment.
AUDITING SERVICES - cGxP
Pharmaceuticals must be produced consistently and must be strictly controlled to meet both national and international standards appropriate for their intended use. Strict regulatory requirements must be met including those specified by US Food and Drug Administration (FDA) or UK Medicines and Healthcare Products Regulatory Authority (MHRA).
CP's auditing team offers Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP) audit services helping our clients to ensure that all relevant regulatory requirements (FDA, NF, MHRA) are met. We provide auditing solutions for all types of pharmaceutical products such as active pharmaceutical ingredients (APIs), drug products, excipients, over-the-counter products, vaccines and vitamins. CP can add value to your business by helping you to achieve or maintain regulatory compliance for equipment, facilities, utilities, processes and process installations. Our global network of experienced auditors are available to conduct audits supporting the entire manufacturing supply chain.
PDMA COMPLIANCE SERVICES
The Prescription Drug Marketing Act requires that Pharmaceutical companies closely monitor the distribution, marketing and tracking of drug samples and are fully accountable for disbursement, inventory transactions and workflow processes. CP's team of experts ensures that your processes & systems are compliant and validated in accordance with 21 CFR 203 &21 CFR Part 11.
COMMISSIONING & QUALIFICATION
CP's Commissioning and Qualification specialists help clients ensure their facility, utilities, and equipment perform as intended. We do that through commissioning and qualification services, using a risk-based approach to maximize time and cost efficiencies through focused qualification efforts.
Our experienced commissioning and qualification team has the technical skills and experience to make our clients' projects successful. By using current industry trends and methods to help define and implement best practices, we quickly adapt to the needs of each individual client, knowing each project has unique requirements.
Equipment Qualification comprises a series of qualifications, such as Design, Installation, Operational, and Performance Qualification, that provide a high degree of assurance of the consistent, expected functioning of a piece equipment. Operating parameters and environment, as well as documented routine maintenance and on-going performance checks, contribute to a life-cycle approach to maintaining equipment in a validated state.
CP's experienced team of equipment qualification experts can assist you with equipment needs including:
Process Validation applies to the production of pharmaceuticals and intermediate products as well as the manufacture of medical devices. Per the FDA Process Validation Guidance, “process validation is defined as the collection and evaluation of data, from the process design stage through commercial production, which establishes scientific evidence that a process is capable of consistently delivering quality product.” This entails on-going documentation and assessment of all constituent elements of the process, such as materials, equipment, operations, and environmental conditions. The primary goal is to gain understanding and control of process variation and its effect on process outcome. CP's team of process validation experts can assist with design of process validation methodologies as well as development and execution of process validation protocols in both pharmaceutical and medical device companies.
PROJECT & PROGRAM MANAGEMENT
Project management consultancy services are necessary and critical to the success of complex projects (those that are high impact and time sensitive) within your organization.
CP's project management consultants utilize process, discipline, and leadership to break down functional silos, engage stakeholders, and ensure your initiatives are completed within budget, scope, and schedule. You can begin a project with us, from initiation to completion or if your project is missing milestones or is lacking momentum we will deploy project management consultants to get your project back on track.
A technology transfer is what happens when a pharmaceutical company wants to change from an existing manufacturing site to a new manufacturing site. CP helps our clients by providing senior level pharmaceutical technology transfer experts to lead each technology transfer project. These projects are multi-year in duration and that is why it is critical to have onsite support for the duration of the project.
QUALITY INVESTIGATIONS CAPA CONSULTING
Investigating the cause of a quality failure or other production problem is something that all pharmaceutical companies must do, some more frequently than others. The more comprehensive and structured the investigation process is, the more effective it will be. While CAPA is handled differently at many pharmaceutical manufacturers, best practices for handling complaints and investigations revolve around certain core activities, a basic process and, more often than not, some enabling technology. CP's Team of Quality Investigation and CAPA experts can assist your company in achieving Quality Investigation compliance.