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.

    As a part of a consent decree response, a Fortune 100 pharmaceutical company contracted RCM to (1) execute an assessment of the compliance and validated state of a QA Management computerized system, and (2) remediate the findings by establishing IT QMS standards and validating the next major system release.

    A team of senior RCM SMEs executed the system compliance assessment six weeks ahead of schedule and under budget. RCM developed and implemented a solution-oriented “Center of Excellence” approach to the project, forming and engaging two teams on project System Validation and Quality Assurance activities.

    As a response to issuance of form FDA-483, a major device manufacturing company engaged RCM to execute the validation/remediation effort for 20+ systems, including equipment, cleaning and manufacturing facilities validation.

    RCM provided three highly effective delivery teams consisting of 5-8 SMEs to address a total of 12 projects on a fixed-price basis. RCM assessed the systems in scope, and defined and implemented the compliance solutions to meet form FDA-483 demands. The implemented solutions included the full validation of Catheter and Cardiac Pump manufacturing lines, as well as full facilities validation.

    As a part of a consent decree response, a top-tier pharmaceutical company needed to (1) assess the compliance state of its computerized systems, Excel spreadsheets and databases used to support stand-alone laboratory systems; and (2) document and address the discovered findings.

    RCM enlisted and managed a team of 28 Validation and 21 CFR Part 11 technical experts who implemented Part 11 strategy and validated 50+ systems, implemented procedural remediation of 15+ systems and implemented and documented retirement of 100+ systems.

    A packaging unit of a pharmaceutical company separated to become a stand-alone company. The organization realized the need for its own IT Quality Management System (QMS), validation of its computerized systems, and qualification of the IT infrastructure.

    RCM engaged two teams consisting of IT Compliance/Validation SMEs and IT Infrastructure Qualification SMEs to meet the effort objectives. RCM defined and executed an IT Remediation Plan to develop a robust and cost-effective governing IT QMS, validate high-risk computerized systems, and qualify the IT infrastructure.

    After attending an RCM webinar, representatives of a Life Sciences industry software vendor organization contacted RCM requesting assistance with improving their IT operations, including

    Part 11 compliance, SDLC and V&V practices, and effective client-vendor relationship management. The Client requested RCM to execute an independent assessment (audit) of their current IT practices and business services provisioning model.

    RCM deployed one of its top SMEs to perform investigation on fixed-price basis, which resulted in a comprehensive summary document that outlined discovered issues and relevant root causes, as well as both the strategic guidance and individual and specific remediation steps.

    The assessment results were presented to Client C-level and Executive Management, were well received and resulted in immediate and specific action items.

    In response to FDA-483, a Global Medical Device Company readily engaged with several firms to undertake the assessments and gap analysis of quality systems, and develop a remediation plan and response to the FDA findings. The Client was left underwhelmed with the firms’ performance and proposed remediation plans. After a rigorous selection process, the company selected RCM to lead and execute the remediation efforts for all of its manufacturing lines on a time and materials basis.

    RCM provided four highly effective delivery teams consisting of a team lead, validation engineers, quality engineers, technical writers, and regulatory experts for four distinct product lines which manufacture over 25 different final product configurations. RCM excelled at the delivery and was awarded numerous additional projects.

    In response to FDA-483, the European facilities of a global manufacturer of drug delivery, medical device and diagnostic products was obligated to provide a well-reasoned, complete, and timely 483 response to the FDA. The Client required the top industry expertise and contacted RCM looking for general guidance and assistance with writing a response to FDA-483.

    RCM responded to the Client’s request for help within two hours of the initial Client communication. RCM engaged one of its top Life Sciences SMEs to perform the required effort on a fixed-price basis. Delivery was overseen by RCM Life Sciences management team. RCM execution allowed the Client to gain control over the situation by fully understanding and properly responding to FDA inspection findings.

    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 compliance.

    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 Qualification activities.

    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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