ERES
Electronic Records and Electronic Signature (ERES) regulation
continues to be a prominent issue for pharmaceutical organisations
throughout the world. Although 21 CFR Part 11 is currently
the most prominent regulation, European directives relating
to use of electronic signatures and ISO Information Security
Management standards mean that this issue has a global perspective.
ISL offer a range of services that enable our customers to
understand the regulation within the context of their business
operation and to apply a practical interpretation enabling
prioritisation of remedial action.
Training
Senior Management seminars/workshops enable senior business
and quality managers to understand the requirements of current
regulation and guidance within the context of their business
operation. These seminars/ workshops define the requirements
of ERES regulation in business terms:
 Scope
and requirements of regulation
Benefits
of compliance
Risks
of non-compliance
Current
regulatory expectations
Detailed 1 and 2 day workshops provide in depth knowledge
of the regulation, processes and tools for assessing compliance
and planning tools for prioritising interim and longer-term
corrective actions. Delegates are given opportunities to discuss
specific issues within their organisation and develop strategies
for achieving pragmatic compliance.
Compliance Programme Setup and Management
We are able to advise on the best approach to achieving compliance.
Be it on a global or local scale, we can advise on Project
Organisation, Project Process, Assessment Tools and Methods,
Reporting Tools and Methods and Training to enable organisations
to achieve appropriate and consistent compliance within a
reasonable time frame.
GAP Analysis and Corrective Action Planning
ERES compliance can consume significant resource from within
an organisation. This brings with it the issues of diverting
resource from critical business operations, backfilling resource
and re-training. We are able to provide project teams to carryout
gap analysis and action planning activities either in full
or to supplement existing customer resource. Our consultants
and practitioners have worked with many organisations and
therefore bring a harmonised perspective of the issues faced
and pragmatic proposals for resolution.
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