FDA’s 21 CFR Part 11 was enacted in the late 1990s and implementation success across the pharmaceutical and other regulated industries have been mixed. There are very specific limitations that arise when using ER/ES capability, such as the elimination of print capability to prevent users from making decisions based on a paper record as opposed to the electronic record. It also requires very specific identification of users that ensures the person signing the record is the same person whose credentials are being entered and verified by the system.
The rule for changing passwords must be rigorously adhered to and the passwords must be kept secure.
It is also critical that the system specify the exact meaning of the signature. It may be that the person conducted the work, recorded the result, reviewed the result, or approved the result. A person may simply be attesting to the fact that they reviewed the work and the signatures, and there was appropriate segregation of duties (i.e., the person recording the result is not the same as either the person reviewing or the person giving final approval).
A company must have specific policies and procedures in place that explicitly state responsibilities and provide guidance for implementing and using ER/ES capability. These must clarify the 21 CFR Part 11 regulation and provide insight as to the way the company interprets its responsibility for meeting it. As FDA continues to evolve and change due to the many factors that influence the regulatory environment, companies must be able to adapt.
New technologies will continue to emerge that will change the way companies do business. While many of these are intended to streamline operations, reducing time and resources, some unintentionally result in added layers of oversight that encumber a computer system validation program and require more time and resources, making the technology unattractive from a cost-benefit perspective.
Why you should attend
FDA requires that all computer systems that handle data regulated by the Agency be validated in accordance with their guidance on computerized systems. This guidance was first issued in 1983, and the main points of focus remain consistent today, despite the number of years that have passed and the technology changes that have taken place.
The guidance was revisited for its application to the medical device industry in the 1990s, as the first issuance addressed pharmaceuticals only. In 1997, 21 CFR Part 11 was issued to address electronic records and signatures, as many FDA-regulated organizations began seeking ways to move into a paperless environment. This guidance has been modified over the years to make it more palatable to industry, and this includes discretionary enforcement measures, but still remains somewhat confusing. The intent was to avoid creating a huge regulatory compliance cost to the industry that was initially preventing companies from embracing the technology.
This seminar will help you understand in detail the application of FDA’s 21 CFR Part 11 guidance on electronic records/electronic signatures (ER/ES) for computer systems subject to FDA regulations. This is critical in order to develop the appropriate validation strategy and achieve the thoroughness required to prove that a system does what it purports to do. It also ensures that a system is maintained in a validated state throughout its entire life cycle, from conception through retirement.
ER/ES capability can vary, and the approach should be based on the specific case and the risk of failing to meet the guidance associated with i
Session 1 (90 Mins):
- FDA Regulatory Oversight
- Computer System Validation (CSV)
- System Development Life Cycle (SDLC) Methodology
- GAMP 5 Software Categorization
- System Risk Assessment
Session 2 (90 Mins):
- 21 CFR Part 11 Compliance (Electronic Records/Electronic Signatures)
- Security, Access, Change Control and Audit Trail
- Validation Documentation
Session 3 (90 Mins):
- 7 Most Common Problems with Validation
- FDA Audit Preparation
Session 4 (90 Mins):
- Policies and Procedures
- Training and Organizational Change Management
- Industry Best Practices and Common Pitfalls
Carolyn (McKillop) Troiano has more than 35 years of experience in the tobacco, pharmaceutical, medical device and other FDA-regulated industries. She has worked directly, or on a consulting basis, for many of the larger pharmaceutical and tobacco companies in the US and Europe, developing and executing compliance strategies and programs. Carolyn is currently active in the Association of Information Technology Professionals (AITP), and Project Management Institute (PMI) chapters in the Richmond, VA area.
Who Should Attend
Personnel in the following roles will benefit:
- Information Technology Analysts
- Information Technology Managers
- QC/QA Managers
- QC/QA Analysts
- Clinical Data Managers
- Clinical Data Scientists
- Analytical Chemists
- Compliance Managers
- Laboratory Managers
- Automation Analysts
- Manufacturing Managers
- Manufacturing Supervisors
- Supply Chain Specialists
- Computer System Validation Specialists
- GMP Training Specialists
- Business Stakeholders responsible for computer system validation planning, execution, reporting, compliance, maintenance and audit
- Consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance
- Auditors engaged in internal inspection