As FDA auditors increase their focus on data integrity issues, it is becoming more difficult for companies to ensure that their data and record management practices are compliant. Data integrity goes beyond the use of compliant and validated systems and requires the implementation of multiple procedures/controls throughout the data life cycle. GAMP Services has experts in current good data and record management practices who can offer the tools and training employees need to maintain data compliance.
Data Integrity Training and Consulting
In recent years data integrity compromises have become an international epidemic in GxP facilities. GAMP Services can help companies can pass their FDA audits through our training programs and consulting services. We have tools and training services that can be tailored to your company’s unique needs, whether your facility is GMP, GLP, or GCP.
Through attending data integrity training, your employees will learn how to reduce costly mistakes and recall by gaining knowledge and understanding of best practices from the most recent data integrity guidance documents. Training participants will learn how to facilitate a no blame culture by encouraging a positive attitude toward finding, fixing, and preventing mistakes. As part of GAMP Services training program, you will receive instruction and training materials based around either an individual or group learning environment. GAMP Services provides training certificates for all employees that attend our training.
Data Integrity Auditing Services
New data integrity guidance calls for enforcing stricter policies for documentation review. The new FDA data integrity draft guidance proposes that the review of audit trails be mandatory and suggests several steps to complete the review. The process that the FDA recommends consists of determining the scope of the problem, implementing a corrective action plan, and removing at all levels individuals responsible for problems from cGxP positions. The FDA also encourages hiring a third-party auditor to serve as an unbiased reviewer. GAMP Services can serve as a third-party auditor to help prepare you for your FDA audits.
Policy and Procedure Review
Our company will review your current policies and procedures for best data integrity practices. We will help you ensure that you are in compliance with major data integrity guidance documents. With our combined experience in Part 11 auditing, data integrity auditing, and producing validation packages for computerized systems we will help optimize your workflow integrity.
Audit Trail Review
GAMP Services auditors have the experience and tools to analyze your audit trails using our audit trail summary report. We can review your audit trails and implement procedures for your company to more easily review audit trails on an ongoing basis. Our tools will make the audit trail review a breeze while identifying more data integrity issues.
GAMP Services has the experience to perform all phases of the data migration process. We can enable your company to move data safely, securely, and compliantly in order to maintain the integrity of your data throughout its lifecycle.
Data Migration – Migrate data from legacy systems and ensure accurate data transfer following FDA guidelines.
The criteria for data integrity was summarized using the abbreviation ALCOA & ALCOA+ which stands for the following attributes
Data Integrity Services
- Complete Data Integrity policy, SOP, reviews and subsequent remediation activities of site control systems and processes
- Generate data maps to describe the data flows throughout the systems and to identify critical data control points/transactions
- Identify data integrity gaps and propose solutions
- Lead and/or assist with remediation activities including any potential validation activities to address identified process and/or equipment data integrity gaps
- Compliance and adherence to all the relevant company policies, industry standards and regulatory expectations
- Development of policies and procedures for the maintenance of the data integrity
- Training
- Data Integrity Audit
- Data Integrity Risk Assessment