An internal audit of The Client's QC Laboratory systems identified a number of major findings relevant to the computerized systems state of compliance and data integrity. The Client retained RCM
to perform an in-depth periodic review with elements of a gap assessment for 20 QC Lab instrument
computerized systems, under the defined Project/Solution model.
RCM managed team assisted The Client with finalizing the project approach; executed an in-depth assessment of 20 QC Lab systems that included such high risk systems as HPLC,
GC, FTIR, uPLC, UV Spec, Raman IR, Near IR, IMS, TOC Analyzers, etc.; documented detailed itemized
remediation activities required to address the identified findings; provided the Client personnel
with on-going guidance and coaching; and Assisted the client with
identifying the “next step” options and selecting the most effective way to
proceed towards the systems remediation.
The assessment covered data integrity, Part 11
compliance, validation/qualification, change controls, operations, security and
user access, data backup and recovery, instrument calibration, etc.RCM LS - Complinace and Data Integrity Assm of QC Lab Systems Case Study
As a part of a consent decree response, a top-tier pharmaceutical company needed to (1) define and implement a process that would assure accuracy of drug safety data being reported to FDA and (2) switch from its current system to Oracle AERS for reporting its drug safety data.
RCM deployed a team of 11 Software Validation experts who (1) helped the customer organization define, deploy and support a unique production process that guaranteed the accuracy of data submitted to Health Authorities; and (2) implemented 21 CFR Part 11 compliance and validated an international deployment of Oracle AERS.
A global health science company requested RCM assistance with IT Infrastructure
Qualification activities relevant to the move of the company hardware
infrastructure from a third-party hosting services provider to various company
locations. The infrastructure project
included the move from one existing to two new Data Centers; establishment of
new networks; move, retirement and creation of physical and virtual servers;
creation of new SAN and Backup environments, etc.
The Client did not have any practices governing Infrastructure
RCM Life Sciences Solution Director assessed the Client’s current practices
and assisted with planning and scoping of the required Infrastructure
Qualification activities. RCM then engaged
a top-tier Sr. IT Compliance/Quality SME who developed the necessary company
practices and successfully carried out the required Infrastructure
A global health science company requested RCM assistance with the
assessment and remediation of the compliant state of its computerized systems
used to support stand-alone laboratory instruments. All assessment findings
needed to be documented and addressed through a formal remediation.
RCM engaged a top-tier Senior IT Compliance/Quality SME who performed
and documented the required assessments, assisted the client with investigation,
selection and implementation of technological solutions, and defined and developed
processes and governing procedures and training covering the risk-based
methodology for 21 CFR Part 11 compliance.
As a result of an impressive growth, a world-wide
leading biopharmaceutical company came under an increased scrutiny of US FDA
and EU MEA agencies. The Client realized
a need for improvement of its IT quality and compliance practices (IT
QMS) and retained RCM to develop the required IT Regulatory Compliance and Quality
Assurance procedures and documents.
RCM small and dynamic team of top RCM SMEs under the oversight of RCM Life Sciences Solutions Director (1) Created
the IT Regulatory Compliance and Quality Management System landscape; (2) Developed
the required SOP, WI and Templates; and (3) Handed over the QMS to the Client for
implementation and maintenance.
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