Audit and Assessment Summary & Trends. CQA Audit Summary 5 Audits conducted (Bayer-2, GSK-1, Roche-1 and Janssen-1). 1 Critical, 7 Major and 25 Minor findings. Supported 2 Reg Inspection (Roche) and supported for 2 Customer audits (Roche and Janssen). Trends Sub-standard Root cause/CAPAs and delayed CAPAs. Disregard for the importance of need to maintain internal compliance. Inadequate HOTO documentation Inadequate documentation of process steps. Regular and ad-hoc connects with accounts to correct and prevent recurrence.. 

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CQA Audit Summary 5 Audits conducted (Bayer-2, GSK-1, Roche-1 and Janssen-1). 1 Critical, 7 Major and 25 Minor findings.  Supported 2 Reg Inspection (Roche) and supported for 2 Customer audits (Roche and Janssen). Trends Sub-standard Root cause/CAPAs and delayed CAPAs. Disregard for the importance of need to maintain internal compliance.   Inadequate HOTO documentation  Inadequate documentation of process steps.  Regular and ad-hoc connects with accounts to correct and prevent recurrence.

Vendor Assessment 2 Vendors assessed for GSK – THG(GSK), DeltaPv. 2 Critical, 6 Major, 9 Minor findings from 2 assessments.  3 Vendors assessment pending– THG (Roche), ULG, Medidata.
 Trends Inserted image of signature used on a regulated document. Lack of evidence of personnel qualification. Lack of evidence for system validation and compliance maintenance. Data leakage risk due to utilization of freelancers.

Customer Audits  Supported 2 Reg Inspection (Roche) and supported for 2 Customer audits (Roche and Janssen).

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De-risking TCS Life Sciences – Account Level

Quality Investigations- JNJ, GSK and Roche – support to do in-depth Root cause and create TCS POV  JNJ –issue was escalated at Rabi’s level.   GSK – PV postal follow –up, signature non-compliance identified.  Roche- extrapolate to verify across individual Projects data minimization.   Bayer-Adequate documentation of the RACI in AI processed and regulatory submitted cases.    Lilly – QMS doc creation – processes delivered without written SOPs. Robust Quality Governance TNC team organized under Clinical Quality.  Initiated tasks to review to get involved in discussions to flag early risk indicators.   CAPA Management offering- GSK and Bayer Build pool of CAPA champions to improve quality of all CAPAs. Sensitizing GLs to look at CAPAs as effective tools to improvise process and systems. Checklist and root cause categories in draft to improve operation’s capability to conduct RCA and adequate CAPAs - starting  with GSK, Bayer.  Quality connects with Sponsors Customer QA to TCS QA connects reinstated for Janssen, GSK and new with Bayer. QA teams should be engaged from ideation, including review of QMS sections of MSAs. Guidance on regulatory inspections and customer / 3rd Party Audit readiness planned No standard guidance on how TCS maintains the state of inspection readiness. CQA and VCoE/CSQA will work to build this guidance along with offering leads and operations.

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De-risking TCS Life Sciences – QMS Level

TCS Digital Signature is the default signature mechanism for Internal LS documents. Email approvals discouraged – CQA sent out an email May end to confirm that only e-digi signatures or wet ink will get.  Digital Signatures of 450+ DMMT associates (leads and above) have been assessed and approved by VCoE.  Transition to One Training Records Management “iTract” system. All Clinical accounts moved to iTract for Training Records Management purposes. Quality and Compliance Managers played a key role in making this happen (Ask ITRACT report from Ravina) Quality (Account and QA) governance set up for tracking compliance. GCP and Regulatory IT Compliance Awareness Session for Clinical Teams. 12 Sessions conducted for 350+ associates (Lead and above) in Mumbai and Bangalore; more sessions planned for next quarters.  CQA has started with drop-in sessions for clarity on TCS SOPs to ensure better compliance.  CQA SOP updates  Drive to update CQA SOPs to keep them aligned to regulatory expectations - Vendor assessment , Severity classifications, Fraud and Misconduct (WIP). User friendly to ensure better compliance – Training and Deviation SOP. Quality goal in CLs  Check on Governance for quality by CLs in audits.  CAPA and Findings dashboard publishing initiated in September.  ADD Safety   Specific to GSK but planned with a generic objective- built a new QMS structure for ADD Safety – based on inputs shared requirements are being rewritten, new SOPs and governance at process and data level reqs etc.

Account Conceptualization Stage Involvement GSK Guidance Shared on: Need for oversight of training, clarity on execution, reference materials easy availability – both TCS and Vendor associates Documentation of start of tasks without SOPs RACI on SOPs/Guidance materials to match TCS capability Bayer TCS Inspection readiness and joint QA committee idea shared Bayer –TCS Joint QAC has got created Training compliance checks before on-boarding on newer tasks Eli Lilly Recurring calls which resulted in fast track of Compliance to creation of role specific Training plans Process manuals in the absence of SOPs SMEs inputs considered. 

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Account  Conceptualization Stage Involvement  GSK  Guidance Shared on: Need for oversight of training, clarity on execution, reference materials easy availability – both TCS and Vendor associates Documentation of start of tasks without SOPs RACI on SOPs/Guidance materials to match TCS capability  Bayer  TCS Inspection readiness and joint QA committee idea shared Bayer –TCS Joint QAC has got created  Training compliance checks before on-boarding on newer tasks  Eli Lilly  Recurring calls which resulted in fast track of  Compliance to creation of role specific Training plans  Process manuals in the absence of SOPs  SMEs inputs considered

Successes of collaboration (#12 calls had over last three quarters) Quarterly connects between Offering leads (CDM, PV, Clin Ops, RA, MW). JNJ- CDM and MW teams working on ideas around peer review and QC from GSK and Roche to build on.  Monthly connects with Customer leaders to share lead indicators of quality and get inputs to retain state of compliance.  Bayer –expanded PV scope – Shared efficiencies created from Roche’s journey for the account to take ahead. CAPA trainings planned for the additional scope.   Training team – Induction sessions in ITRACT- complete lifecycle of associate in the Training system.

Work in progress  Co-ordination between Offering leads, accounts and QA to ensure awareness of  regulatory updates and impact assessment

Audit and Assessment Summary & Trends

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