Life Sciences & Pharma
Your FDA Audit Has a Date.
Your Batch Records Are in Spreadsheets.
Pharmaceutical manufacturers, biotech firms, and medical device companies operate under FDA 21 CFR Part 11 requirements that most ERP systems were never designed to meet. Batch records, lot genealogy, electronic signatures, and IQ/OQ/PQ documentation cannot be assembled after the inspection arrives. Compliance is the architecture, not the afterthought.
FDA 21 CFR Part 11
GxP Compliance
HIPAA
IQ / OQ / PQ
SOC II Type II
What’s Driving the Conversation
The Situations That Bring
Life Sciences Companies to TechWise.
Each conversation starts somewhere different. The common thread is a compliance gap the current system cannot close on its own.
“Our ERP was never validated for 21 CFR Part 11. Our FDA auditor flagged it. We have 90 days to remediate and we do not know where to start.“
VP of Quality, Pharmaceutical Manufacturer
“We run batch records in Excel. Our lot genealogy is manual. We have an FDA inspection scheduled and our system is not audit-ready.“
Director of Operations, Biotech Company
“We are implementing Copilot across our organization. Nobody has asked what happens when it surfaces clinical data to users who should not have access to it.“
CIO, Medical Device Manufacturer
“We need IQ/OQ/PQ documentation for our ERP implementation and our implementation partner has never done it before. We are past go-live and still do not have it.“
Compliance Officer, Life Sciences Company
FDA 21 CFR Part 11 Architecture
21 CFR Part 11 Is an Architecture Decision.
Not a Documentation Exercise.
Most ERP implementations for life sciences companies treat FDA compliance as a documentation layer added at the end. TechWise treats it as an architecture requirement from Day 1. Electronic records, electronic signatures, audit trail integrity, and change control are built into the system, not retrofitted when the auditor asks for evidence that does not exist.
Electronic Records
Batch Records That Hold Up Under Inspection.
FDA 21 CFR Part 11 requires that electronic batch records be trustworthy, reliable, and equivalent to paper records. Spreadsheets, shared drives, and unvalidated ERP configurations do not meet this standard. TechWise implements validated electronic batch records with the audit trail integrity that survives an inspection.
Computer System Validation
IQ/OQ/PQ Documentation You Can Show an Auditor.
Installation Qualification, Operational Qualification, and Performance Qualification documentation is not optional for FDA-regulated ERP systems. TechWise produces the validation protocols, test scripts, and summary reports that constitute a defensible IQ/OQ/PQ package, maintained through change control as the system evolves.
Audit Trail Integrity
Every Change Recorded. None Alterable.
21 CFR Part 11 requires audit trails that capture who made every change, when they made it, and what the previous value was. The audit trail cannot be disabled, altered, or overwritten. TechWise configures audit trail architecture that satisfies this requirement across the ERP environment and any integrated systems.
CAPA & Lot Traceability
Lot Genealogy and CAPA Workflows Built In.
Full lot genealogy from raw material receipt through finished goods release. CAPA workflows with documented investigation, root cause analysis, and closure evidence. Deviation management with configurable escalation paths. These are compliance requirements in GxP environments, not optional modules. TechWise implements them as core functionality, not afterthoughts.
Services for Life Sciences & Pharma
ERP First. Everything Else
Built to the Same Compliance Standard.
For pharmaceutical manufacturers, biotech firms, and medical device companies, ERP is the primary entry point. Managed IT, security, and Microsoft 365 follow, all configured for the same FDA-aligned and HIPAA-compliant environment.
ERP & Business Central
ERP That Was Built for FDA-Regulated Environments.
Business Central implementation for pharmaceutical manufacturers, biotech firms, and medical device companies. Electronic batch records, lot genealogy, CAPA workflows, electronic signatures, and IQ/OQ/PQ validation documentation. Former controllers on every engagement. Compliance is the architecture, not the afterthought.
See ERP Services →
Security & Compliance
FDA and HIPAA Compliance in the Same Security Architecture.
Life sciences organizations frequently carry both FDA and HIPAA obligations. TechWise designs the security architecture to satisfy both frameworks simultaneously. Access controls, audit trails, role-based permissions, and identity governance configured for the regulatory environment the organization actually operates in.
See Security Services →
Managed IT
IT Infrastructure Managed for a GxP Environment.
Full-service managed IT for life sciences organizations with specific experience managing environments under GxP, 21 CFR Part 11, and HIPAA requirements. Endpoint management, access controls, change control documentation, and audit trail maintenance as part of the managed service.
See Managed IT →
Microsoft 365
Microsoft 365 Configured for Regulated Data Environments.
Purview data classification, retention policies, and access permissions configured for environments that handle confidential clinical data, intellectual property, and proprietary formulations. Electronic signature workflows built inside Microsoft 365 for document approval processes that satisfy Part 11 requirements.
See Microsoft 365 Services →
AI Security
Copilot in a Regulated Environment Requires Governance First.
Microsoft Copilot surfaces everything the user has permission to access. In a life sciences environment with clinical trial data, formulation records, and proprietary research, ungoverned Copilot activation is a compliance exposure. TechWise governs the data classification and access architecture before any AI deployment in a regulated environment.
See AI Security Services →
VAPT
Your Environment Gets Tested Before an Auditor Tests It for You.
Vulnerability assessment and penetration testing for life sciences environments with findings mapped to FDA, HIPAA, and NIST frameworks. The security posture documentation produced is formatted to answer regulatory questionnaires, cyber insurance applications, and auditor evidence requests without translation.
See VAPT Services →
Tell Us What’s Broken.
We’ll Tell You How to Fix It.
Every managed engagement starts with a free assessment of your environment: no scope surprises. Tell us what’s broken, what’s keeping you up at night, or what you’re trying to build. We’ll tell you exactly what it takes and which model fits.