Overview:
The Webinar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES).
The Webinar will focus on the importance of ensuring that electronic
record/electronic signature (ER/ES) capability built into FDA-regulated
computer systems meets compliance with 21 CFR Part 11. This includes
development of a company philosophy and approach, and incorporating it
into the overall computer system validation program and plans for
individual systems that have this capability.
FDA's 21 CFR Part 11
was enacted in the late 1990s and implementation success across the
pharmaceutical and other regulated industries has 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. 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 their 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 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 it.
Who 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