Erode & Coimbatore, Tamil Nadu info@b2ktrans.com +91 97886 32846
LinkedIn
§ Quality & Compliance

The quality system
behind every B2K delivery.

Four QC rounds per file, Root Cause Analysis on every exception, 99.5% monthly SLA, and enterprise-grade security infrastructure — documented, measured, and audit-ready.

Monthly SLA target
99.5% TAT & quality
QC rounds per file
4 + RCA gate
Compliance posture
21 CFR · HIPAA · GDPR
Subcontracting
Zero
01 — Four-Round Quality Control

No file released without clearance at every stage.

Every QC round is executed by a named role independent of the previous stage. The QA Final Gate reviewer is always independent of production.

#StageResponsible roleWhat is verified
01Paginator Self-CheckProducerOwn output verified against template, style guide, and client specifications before passing forward. No file advances without explicit self-sign-off.
02Senior ReviewSenior paginatorIndependent audit of layout, fonts, spacing, and document-wide consistency. Specifically designed to catch what self-review misses.
03QC ReviewQC reviewerIndependent quality control inspection — fonts, layout integrity, document-wide consistency, and template fidelity. Catches production-level defects before the standards-compliance review. No file proceeds to QA without explicit QC clearance.
04QA Final GateQA teamFinal sign-off authority, independent of production. Verification against client style guide, SLA parameters, and regulatory formatting requirements — the standards-compliance gate for pharma and regulatory clients. No file is released for delivery without explicit QA clearance at this stage. Gate cannot be skipped.
02 — SLA & Error Governance

Measured outcomes. Filed exceptions. Closed loops.

Quality at B2K is contracted, tracked, and reported monthly. Every breach files an RCA. Every fix traces back to a workflow root cause. Numbers shared with the client without being asked.

99.5%
Monthly TAT & quality SLA
Agreed, measured, and reported monthly. TAT defined per file complexity class at project start. A contractual target — not a general claim.
5-Why
RCA methodology
Every delivery exception triggers a Root Cause Analysis using 5-Why methodology. Traces every error to its workflow origin. Preventive measures implemented and verified before the next run.
100%
In-house delivery
Every file handled by full-time B2K professionals under direct quality oversight. No subcontracting. Quality governance extends to every operator on every file.
  • SLA definition TAT and quality targets agreed at project start, per file complexity class — standard, complex, critical.
  • Measurement Tracked daily. Reported to client monthly. No exceptions.
  • Exception handling RCA filed for every breach. Preventive action tracked to closure.
  • Peak volume Tuesday–Thursday staffed at maximum shift capacity to absorb volume surges.
  • Escalation path Named Project Manager per client account — single point of contact for all SLA queries.

What 99.5% means in practice

Any file that misses the agreed TAT window triggers a filed RCA with client notification — without exception.

The SLA is not a retrospective report. It is tracked live, project by project, and the number is shared with the client monthly — without being asked.

03 — Infrastructure & Security

Enterprise security. Operational today.

Every security measure below is in place and operational — not planned. Audit-ready documentation on every file, every shift.

Sophos Firewall
Enterprise-grade perimeter security. Role-based access controls restrict file access to the named project team only.
Role-Based Access Control
Windows Server RBAC. No operator accesses files outside their assigned project scope. All access logged and auditable.
CCTV & Physical Security
Production floors under continuous CCTV. Physical access restricted. No personal devices permitted in production areas.
Audit-Ready Communications
All client communication via email — documented, timestamped, audit-ready. No verbal approvals. Every instruction in writing.
Power & Connectivity Redundancy
15 KVA UPS + 60 KVA generator. Dual internet: 8 Mbps ILL + 100 Mbps broadband. Zero unplanned downtime in 36 months.
NDA Before Briefing
Non-disclosure agreement signed before any client file is shared. No briefing begins without executed NDA in place.
04 — Compliance Frameworks

Built for the standards each industry demands.

Three service verticals, three regulatory regimes. B2K operations are designed, documented, and audited against the framework that governs each line of work.

Pharma DTP & Regulatory Publishing

Pharma & regulatory frameworks.

Every clinical, regulatory, and pharmacovigilance document is produced under the standards that govern submission to the FDA, EMA, and other global health authorities.

  • 21 CFR Part 11 — FDA electronic records & electronic signatures
  • EU Annex 11 — EU GMP for computerised systems
  • eCTD & CTD format — Common Technical Document structure
  • ICH E6 R2/R3 — Good Clinical Practice (GCP)
  • ICH E2A–E2F — Pharmacovigilance: SUSAR, SAE, PSUR
  • ICH E3 — Clinical Study Report (CSR) structure
  • EMA QRD templates — Quality Review of Documents (SmPC, PIL, labelling)
  • GxP-aligned procedures — SOPs, change control, version management, named-reviewer sign-off
Healthcare Services

HIPAA-compliant healthcare operations.

Every healthcare workflow — transcription, coding, claims, content — is run as a HIPAA-compliant operation, with Protected Health Information handled to US healthcare data-protection standards.

  • HIPAA Privacy Rule — PHI access controls, minimum-necessary principle
  • HIPAA Security Rule — administrative, physical, and technical safeguards
  • HITECH Act — breach notification, enforcement, audit trails
  • BAA-ready — Business Associate Agreement signed on engagement
  • Encrypted PHI workflows — at rest and in transit; named-reviewer access only
  • ICD-10 & CPT awareness — for medical coding and claims work
  • Audited access trails — every PHI touch logged and reviewable
  • Heritage — largest vendor to Nuance Communications 2008–17, US clinical documentation at enterprise scale
Data Protection · cross-cutting

GDPR-compliant data handling.

For every European client and every personal-data workflow, B2K operates as a GDPR-compliant data processor — with the agreements, controls, and procedures EU regulators expect.

  • GDPR Article 28 — processor obligations met in full
  • Data Processing Agreement — DPA signed on engagement, on request
  • Standard Contractual Clauses — for EU-to-India and other cross-border transfers
  • Right-to-erasure procedures — documented data-subject request handling
  • Breach notification protocol — 72-hour notice to client & supervisory authority
  • Data minimisation & purpose limitation — embedded in production SOPs
  • Article 30 records — Records of Processing maintained per client engagement
  • Data residency options — available on request
05 — Certifications & Standards

Our quality standards & certification roadmap.

B2K operates under a documented Quality Management System aligned to ISO 9001 principles. Formal certification is in progress.

Operational now
ISO 9001-aligned QMS
Documented Quality Management System with SOPs, process controls, multi-stage QC, and RCA governance across all production verticals. Aligned to ISO 9001:2015 principles. Internal audit cycles in place.
In progress
ISO 9001:2015 Formal Certification
Formal ISO 9001:2015 certification underway. Gap analysis completed. Third-party audit scheduled. Current QMS documentation package available on request for clients requiring evidence.
Operational now
21 CFR Part 11 Aligned
Electronic records and signatures handled to FDA 21 CFR Part 11 standards: validated workflows, audit trails on every change, named-reviewer signoff, time-stamped versioning archived per project.
Operational now
GxP-Aligned Operations
Pharma DTP and regulatory operations run under GxP-aligned procedures: SOPs per document type, change control, version management, and named-reviewer sign-off on every file. Audit trail archived per project.
Operational now
HIPAA-Compliant Operations
Healthcare workflows run under HIPAA Privacy & Security Rules: BAA-ready engagement, encrypted PHI handling, minimum-necessary access, audited access trails. HITECH Act breach-notification protocols in place.
Operational now
GDPR-Compliant Data Handling
Data Processing Agreement (Article 28) signed on engagement. Standard Contractual Clauses for cross-border transfers. Article 30 records, breach-notification, and data-subject request procedures documented and operational.
Roadmap
ISO 27001 Information Security
ISO 27001 ISMS certification on the formal roadmap. Current security infrastructure (Sophos perimeter, RBAC, CCTV, encrypted comms, audit trails) is 27001-aligned and operational today.

Request our
QMS documentation package.

Available on request for procurement due diligence. NDA signed before sharing.

Request documentation →