Our assessment services are designed to help clients ensure that electronic records and electronic signatures are in conformance with the requirements of 21 CFR Part 11.

Arbour Group’s experienced professionals are extensively trained to evaluate a client’s use and documentation of electronic records and electronic signatures as prescribed by applicable regulatory requirements.

Our Electronic Records/Electronic Signatures Assessment Services are a “must-have” investment in helping clients understand and comply with the requirements of 21 CFR Part 11.

Part 11 Assessment

As a global leader specializing in providing a full scope of validation services for computer systems, software and medical devices within pharmaceutical, medical device and biotechnology companies worldwide, Arbour Group L.L.C. is well-credentialed to identify, interpret and respond to emerging regulatory requirements as they impact mission-critical elements of our clients' operations. One such area that commands priority attention is the assessment of compliance with Electronic Records/Electronic Signatures (21 CFR Part 11). Our assessment services are designed to help clients ensure that electronic records and electronic signatures are trustworthy, reliable and generally equivalent substitutes for paper records and traditional handwritten signatures and that those functions are in conformance with the requirements of 21 CFR Part 11.

Assessment Objective - Arbour Group's experienced professionals are extensively trained to evaluate a client's use and documentation of electronic records and electronic signatures as governed by applicable regulatory requirements. The result of an assessment project determines the effectiveness of a client's process within a highly regulated environment and suggests the appropriate remedial actions that might be necessary.

Assessment Procedure

Initiation Meeting - Arbour Group will conduct an initiation meeting with the client's team to discuss specific details of the audit and describe the process of the assessment. Topics covered typically include system evaluation, assessment methodology and applicable regulations and industry guidelines, as well as the scope and criteria of the assessment, consulting team composition, procedural logistics and reporting format.

Process - The assessment is conducted using Arbour Group's Part 11 Gap Analysis Methodology, which is adapted to accommodate the client's specific environment and operating situation. The assessment will focus on six critical areas:

• the impact of 21 CFR Part 11 on the client's computer systems
• the identification of the client's computer systems and operating environment
• the hosting and interpretation of user interviews
• the review and consideration of client procedures
• the analysis of procedural documentation, validation and audit data
• the regulatory significance of the computer systems

Those areas of assessment may be tailored to incorporate the following:

• the type of assessment (internal, second party or third party)
• the method of electronic data handling and retention
• the level of the client's utilization of electronic records and electronic signatures
• the business application of electronic information

Findings - Assessment findings will be analyzed in accordance with various and appropriate requirements:

• regulations
• guidelines
• compliance policy guides
• warning letters and 483s

Results - The results of the assessment will be presented to the client in a clear and concise manner and will discuss proposed remedial plans and timetables and delineate the strengths and weaknesses of the client's use of electronic records and electronic signatures. This presentation will be provided in a summary format and will include detailed supporting evidence and reference materials. The client will receive a final report, which will detail the assessment findings, suggest interim measures and permanent remedial solutions and project anticipated results.