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Lucid provides assistance to our client's seeking GLP, GMP and GCP compliance. A portion of our work also falls into more traditional Quality Assurance and Data Management roles. Below are some examples of the work we have performed for our clients.

We perform these services, almost exclusively, to clients too small to justify full-time, in-house positions or to larger clients with the in-house expertise, but are experiencing a temporary increase in the demands on those positions due to imminent filings, temporary personnel shortages due to personnel leave, or unplanned schedule overlaps.

Please contact us if you have any questions or have a temporary need in the following areas:

GLP Services

In addition to our consulting on GLP-compliant systems and processes, Lucid provides auditing of nearly every facet of GLP. Our auditors in this area all have extensive laboratory experience before they were trained as auditors. We believe chemists and bench analysts make the best auditors for GLP work.

Our auditors are self-sufficient in working their way through a laboratory and the required documentation. As former bench analysts, our auditors are also well suited to directly observing bench-level work. Together, we provide the feedback that our clients need to be assured their operation meets GLP requirements and also to be assured the analytical techniques observed during the audit meet industry standards.

GLP Consulting

• Program Design

• Program Compliance Audits

• Benchmark Testing

Audited Phases and Timing

• In-House Laboratories

• Real-time Analysis

• Documentation of Completed Studies

• Contract Laboratory

• Pre-contract Due Diligence

• Documentation of Completed Studies

Audited Activities

• GLP Compliance Evaluations

• Direct Observation of Sample Analysis

• Analytical QC Data Compliance and

Processing

• Sample Analysis Reports

• Analytical Method Validation

• Data capture and processing

• Laboratory Notebook and Documentation

Control

• SOP Development and Control

• LIMS audits

• Electronic Records, Electronic Signature

Compliance

• Computer System Validation

• Data analysis

• Statistics

GMP Services

Our auditors are well versed in GMP requirements. We have performed audits of raw material suppliers all the way through in-house manufacturing and batch record generation. In addition, we regularly send our auditors for training to insure they understand the latest requirements, and also to keep abreast of changes in industry standards.

GMP Consulting

• Program Design

• Program Compliance Audits

• Benchmark Testing

Audited Phases and Timing

• In-House Facilities

• Planning and Design

• Real-time Observations

• Documentation of Completed Projects

• In-house Facilities

• Planning and Design

• Real-Time Observations

• Documentation of Completed Projects

• Contractors

• Assess Potential Contractors

• Production

• Packaging

• Storage and Distribution

• Engineering

• Software Development

• Raw Material Suppliers

• Post-Process Performance and

Documentation Review

Audited Activities

• Pre-FDA Inspection Preparation

• Facilities Audits

• Equipment Audits and Validation

• Stability Testing

• In-Process and Release Testing

• Batch Record Compliance Reviews

• Product Storage and Distribution

• SOP Documentation and Control

• Review of Validation Protocols

• Master Record Compliance Reviews

• Electronic Records, Electronic Signature

Compliance

• Data Analysis and Statistics

GCP Services

In addition to auditing the data that is generated during clinical and non-clinical studies, our auditors have been tasked to directly observe the trials. This provides our client with the opportunity to obtain independent verification of the operation of the study as well as an assessment of the completeness and accuracy of the study information, and the level of compliance to the protocols.

Whether you need a small portion of your study checked for accuracy, or need independent verification of the compliance of in-house and remote contract facilities, our auditors are prepared to assist your project.

GCP Consulting

• Program Design

• Program Compliance Audits

• Benchmark Testing

Audited Organizations

• Investigative Sites

• Toxicology Laboratories

• Data Capture and Reporting

Audit Timing

• Real-time Analysis

• Documentation of Completed Studies

Audited Activities

• Vendor Audits and Oversight

• Clinical Study Reports

• Data Capture of Case Report Form

• Clinical Observation Audits

• Non-Clinical Observation Audits

• Clinical Study Files

• Completion of Case Report Forms

• Study Compliance to Protocols

• Computer System Validation

• TK/PK Studies

• Toxicology Laboratories and Studies

• Database Validation

• CRO Evaluation and Oversight

• Biostatistics Audits

Quality Assurance

Not every audit we perform has a direct correlation to GLP, GMP or GCP requirements. We also perform audits that fall into more general categories, such as quality systems, general facility operations and reporting accuracy.

Audited Activities

• QA System Review

• Contractor Oversight Programs

• Documentation Control

• SOP Review

• Training and Personnel Qualification Records

• Electronic Records and Signatures

Data Management

For larger studies, databases are used to capture a large amount of very critical information. To insure an accurate report, the database must accurately and completely capture all necessary information. Then, the processing of the database information must be accurate.

Our auditors perform complete reviews to assure the data entry was performed perfectly. In addition, our database personnel can validate the data processing to assure than the processed results accurately reflect the raw data.

Audited Activities

• Data Entry Accuracy Verification

• Contractor Oversight

• Data Processing Verification

• Software Validation