Life Sciences Organizations engaged in drug development face an increasingly challenging environment: an expanding global footprint for clinical trials, evolving regulatory requirements, dynamic partnership models, and rapidly evolving technology. At the same time, many organizations are also innovating how trials are designed and conducted, adding to the complexity. Managing this complexity could be greatly enhanced by an effective and efficient Validation Life Cycle Management Solution (VLMS) and Quality Management System (QMS). However, what constitutes an effective and efficient QMS is not well defined for clinical development. Cereblis QMS Consulting Services helps to develop a flexible, holistic, clinical QMS framework to address this gap and helps Quality Management System Design, Gap Analysis, Implementation, and Improvement.
Title 21 CFR Part 11 requires companies to implement controls, including audits, system validations, audit trails, electronic signatures, and documentation for software and systems that are involved in processing many forms of data, as part of their business practices and product development. We will help you to adopt a digital system of record-keeping while being compliant & complete the digital transformation of your QMS. Cereblis will help you identify, advise and implement innovative Validation Life Cycle management (VLMS) solution to address your 21 CFR Part 11, 21 CFR part Annex 11, GAMP 5, Change management, Release Management, Risk Assessment and digitize IQ, OQ, and PQ documentation requirements.
Life Sciences Organizations engaged in drug development face an increasingly challenging environment: an expanding global footprint for clinical trials, evolving regulatory requirements, dynamic partnership models, and rapidly evolving technology. At the same time, many organizations are also innovating how trials are designed and conducted, adding to the complexity. Managing this complexity could be greatly enhanced by an effective and efficient Computer System Validation (CSV) and Quality Management System (QMS).
Computer systems validation (CSV) is a critical requirement from the regulatory perspective (U.S. FDA, EMA e.t.c). The validation process is designed to provide a high degree of assurance that both new and existing computer systems will consistently fulfill their intended purpose by producing results which meet predetermined specifications and quality attributes – accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records.
As Life Sciences applications constantly evolve to keep up with the needs of the people and businesses that use them, Life Science companies must perform validation activities on an ongoing basis in order to reduce compliance risk, ensure quality, and maintain data integrity.A “Computer System” in an FDA regulated laboratory is more than just computer hardware and software – it also includes any equipment and instruments linked to the system, as well as the trained staff that operate the system and/or equipment using Standard Operating Procedures (SOPs) and manuals. Computer system validation requires a comprehensive set of both static and dynamic testing activities that must be conducted throughout the Software Document Life Cycle (SDLC)
At Cereblis, we are experts in IT risk identification and management along with regulatory compliance. As such, we understand that computer system validation is not a “one size fits all” process. With over 20 years of validation experience, we work to create CSV processes that are based on the latest FDA regulations and guidance (GAMP®5: A Risk-Based Approach to Compliant GxP Computerized Systems), best practices, and the characteristics of the system being validated.
We follow a risk-centric approach for discovering validation methods with promising cost-effectiveness and productivity while maintaining compliance with existing operations and regulatory precedents.
Specifications serve as a formidable element for system design, testing, and software solutions’ intended business use. Our experts recognize the requirement for specifications with accuracy, testability, completeness, and scalability on the grounds of system complexity, criticality, and risks.
Testing is undoubtedly the most crucial aspect of validation projects. Comprehensive design and implementation of the testing strategy offers many advantages. You can ensure better accuracy in verifying system installation or qualifying system functionality.
Testing also assures the system aligning with its intended use according to system specifications or user requirements. The development and execution of suitable approaches for testing protocols are also done by us.
At the same time, we also utilize supplier/vendor testing alongside implementing risk-based methods for optimization and alignment with the budget and schedule for your validation project.
Validation reports are comprehensive sources of information for internal or external auditors as well as stakeholders. The reports provide significant information regarding the outcomes of the validation process.
We can help you find a reliable structure and trustworthy guidance to maintain a system’s validated state. Maintaining your systems in the validated state is essential in cases that involve the implementation of system enhancements, updates, patches, and bug fixes.
Our vast-ranging experience in serving different clients alongside training their staff for computer system validation projects serves as our top strength. We provide customized instructions to our clients for computer system validation projects.
The instructions provide an in-depth overview of industry standards and best practices for developing and implementing computer system validation projects. Our experts consult thoroughly with clients to address all the compliance pitfalls that exist or could possibly arise over the course of the project.
Another top factor that boosts our portfolio of CSV services is compliance auditing. Our team of experts has a niche specialization in reviewing the non-validated, conventional systems of clients. As a result, you can quickly identify the systems which need your attention for a computer system validation project. Our experts’ simple yet comprehensive audit can help you find the best way to achieve compliance for your overall computer system.