Laboratory Assets and Method Validation
Sequence simplifies the laboratory validation requirement for the modern-day regulated laboratory. Whether an entire laboratory validation process needs to be implemented, optimized, or remediated, Sequence methodologies simplify the process. Sequence is always available to provide laboratory validation consultants as needed to ensure that instrument and equipment do not take an excessively long time to implement awaiting validation activities.
Sequence prides itself in providing laboratory compliance consultants that have an extensive background working within a cGxP laboratory. Our dedicated laboratory compliance consultants work alongside your staff as a single unit forming a mutually beneficial partnership ensuring compliance with your instrumentation, equipment, methods, and critical laboratory data.
Laboratory Validation Program Development
Sequence has extensive experience developing validation programs specifically for the laboratory. With each client, our consultants take into consideration the specific regulatory requirements, level of risk the client is willing to assume, staff knowledge base, and budget constraints to implement and effective laboratory validation program.
- Gap assessment and process optimization of existing laboratory validation programs
- Laboratory validation program implementation and training
- Validation program management
- Author and execute laboratory asset qualifications
- Author and execute laboratory method validations
- Author and execute data integrity and server-based software validations
- 21 CFR Part 11 and EudraLex Vol. 4 Annex 11 validation strategy
Laboratory Asset Qualification
Sequence has extensive experience qualifying laboratory instrumentation and equipment for regulated industries. With each validation, our consultants take into consideration the technical complexity of the asset, degree of customization, and intended use by our clients. This allows us to implement an effective, risk-based approach for each laboratory asset’s qualification effort. Sequence provides the following validation lifecycle deliverables:
- Regulatory Assessment
- Validation Plan
- User Requirement Specification
- Vendor Qualification Package
- Supplemental In-House Installation and Operational Qualification (IOQ)
- In-House Performance Qualification (PQ)
- Protocol Final Report(s)
- Traceability Matrix
- Operational and Administrative SOP(s)
- Validation Summary Report
- Periodic Review
Sequence provides method transfer and method validation services adhering to USP compendial guidelines for analytical and microbiological processes. Sequence encourages our clients to perform method development steps before validating a method to determine the initial assessment of risk to the client, identify the method requirements, perform an evaluation of robustness, and determine influential parameters that can affect the test results.
Sequence performs method verification and method validation for analytical and microbiological test methods for:
- Finished product for release
- Stability samples
- Raw materials
- Manufacturing process intermediates