Uncompromising Compliance.
Defensible Analytical Integrity.
Every testing sequence executed inside our 8,500 sq. ft. laboratory is governed by closed computerized systems, indelible electronic audit trails, validated SOPs, and international pharmacopoeial standards.
Four Pillars of Regulatory Integrity
Engineered to withstand scrutiny from domestic drug authorities (CDSCO/FDCA) and global regulators (US FDA, EMA, WHO)
Good Laboratory Practice (cGLP)
Institutionalized quality management protocols ensuring every assay, dissolution study, and raw material clearance is executed per version-controlled standard operating procedures (SOPs).
21 CFR Part 11 & Annex 11 Compliance
Closed-system architecture governing analytical chromatography software. Raw analytical data cannot be renamed, overwritten, deleted, or suppressed under any circumstance.
ALCOA+ Data Governance Principles
Comprehensive compliance across all 9 data integrity dimensions ensuring regulatory defensibility during US FDA, EMA, MHRA, and CDSCO sponsor submissions.
Pharmacopoeial Harmonization
Subscribed to official real-time pharmacopoeial updates. Every assay method, system suitability parameter, and monograph limit is maintained to current active editions.
Our 5-Stage QMS Workflow
Traceable chain of custody from courier receipt to digitally signed Certificate of Analysis (CoA)
Sample Inward & Chain of Custody
Inspected for container integrity, temperature-logging status & logged into inward ledger with unique LIMS sample identifier.
Method Protocol & Suitability
Analyst confirms instrument calibration validity. System suitability sequence verified (RSD%, tailing, theoretical plates).
Analysis Execution Under 21 CFR Part 11
Sequence runs in closed computerized environment. Every injection logged to server audit trail with time stamp.
Four-Eye Data Verification
Primary analyst recalculates, Senior Reviewer checks raw chromatograms, and QA Manager inspects full audit log.
Digitally Signed CoA Release
Tamper-evident Certificate of Analysis issued with QR verification, study reference, and complete raw data archival.
Welcome Your Quality Assurance Auditors to Vapi
Satvam Research operates an open-door policy for qualified pharmaceutical sponsors, QA auditors, and regulatory inspectors. We provide immediate access to computerized workstations, unedited audit logs, and equipment validation binders.
Schedule an On-Site Audit
Speak directly with our QA Compliance department to request an audit date, vendor assessment questionnaire, or Site Master File.
Compliance & Data Integrity FAQs
How does Satvam Research guarantee 21 CFR Part 11 compliance for chromatography workstations?
All analytical workstations controlling our Shimadzu HPLC, Shimadzu GC-HS, and Lab India ICP-OES instruments run licensed chromatography software featuring multi-tiered, role-based user access controls (Analyst, Reviewer, QA Admin). System audit trails are enabled globally and cannot be disabled or edited. Every integration change, injection sequence, sample name, and recalculation generates an indelible timestamped log with analyst identity.
What is your data retention policy and backup schedule?
Analytical raw data, calibration curves, processing methods, and audit trails are archived automatically every 24 hours to secure, mirrored on-premise RAID servers with off-site encrypted redundancy. Data is preserved for a minimum of 7 years (or client-stipulated commercial retention periods) in compliance with international regulatory expectations.
Can our regulatory affairs or QA team conduct an on-site facility audit at Vapi?
Yes. We welcome prospective and existing clients to conduct formal vendor qualification and quality audits. Our facility includes a dedicated client audit conference suite with immediate access to unredacted SOPs, training dossiers, instrument IQ/OQ/PQ qualification binders, and live audit trail demonstrations.
How does Satvam Research investigate Out of Specification (OOS) and Out of Trend (OOT) test results?
We adhere strictly to US FDA guidance on Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production. Any atypical result triggers an immediate Phase I laboratory investigation by an independent QA officer to rule out analytical or instrument error before any re-testing is authorized. Phase II investigations assess manufacturing or sampling roots in close collaboration with the sponsor.
Which pharmacopoeial compendia and international guidelines do you support?
We operate against current official editions of Indian Pharmacopoeia (IP), British Pharmacopoeia (BP), United States Pharmacopeia - National Formulary (USP-NF), European Pharmacopoeia (Ph. Eur. / EP), Japanese Pharmacopoeia (JP), Bureau of Indian Standards (IS: 10500:2012), and ICH Quality Guidelines (Q1A to Q6B).
Partner With a Defensible Analytical Laboratory
Protect your commercial release schedules and regulatory dossiers with verified data integrity from Satvam Research.