21 CFR Part 11 Assessment
Part 11 Assesment).
Our assessment services are designed to help clients ensure that electronic records and electronic signatures are trustworthy, reliable, 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 a 21 CFR Part 11 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 21 CRF part 11 assessment. Topics covered typically include system evaluation, assessment methodology, 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:
- Impact of 21 CFR Part 11 on the client's computer systems
- Identification of the client's computer systems and operating environment
- Hosting and interpretation of user interviews
- Review and consideration of client procedures
- Analysis of procedural documentation, validation and audit data
- Regulatory significance of the computer systems
Those areas of the assessment may be tailored to incorporate the following:
- Type of assessment (internal, second party, or third party)
- Method of electronic data handling and retention
- Level of the client's utilization of electronic records and electronic signatures
- 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. Strengths and weaknesses of the client's use of electronic records and signatures, along with remedial plans and timetables will be discussed. 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, permanent remedial solutions, and discuss anticipated results.
