Infor M3 Pharmaceutical Compliance and Regulatory Setup
Pharmaceutical manufacturers running Infor M3 must meet rigorous regulatory standards including FDA 21 CFR Part 11, EU Annex 11, and current Good Manufacturing Practice (cGMP). M3 provides built-in capabilities for electronic signatures, audit trails, and lot genealogy, but these features require precise configuration across the security model, quality module, and manufacturing execution layer. Incorrect setup can result in FDA warning letters and production shutdowns.
21 CFR Part 11 Electronic Records and Signatures
FDA 21 CFR Part 11 mandates that electronic records carry the same legal weight as paper records, requiring secure audit trails, electronic signatures, and user authentication controls. In M3, this is configured through the security framework in MNS150 (User Settings), CRS065 (System Parameters), and the M3 Audit Trail functionality. Every critical transaction must be traceable to an authenticated user with timestamp and reason codes.
- Enable M3 audit trail logging in CRS065 for all GMP-critical programs including MMS001, PDS001, and QMS300
- Configure electronic signature requirements in MNS150 with dual-authentication for batch release and specification changes
- Set up reason codes in CRS900 requiring operators to document why changes were made to master data or batch records
- Define user role separation in MNS410 ensuring quality, production, and warehouse roles cannot approve their own transactions
- Establish password complexity and session timeout policies in MNS150 meeting FDA electronic signature requirements
GMP Batch Record and Lot Genealogy Configuration
cGMP requires complete batch records that trace every ingredient lot, process step, and quality decision from raw material receipt through finished good release. M3 captures this genealogy through the MILOMA (Lot Master) and MWOHED (Manufacturing Order Header) tables. Configuring lot status management in MMS080 and batch disposition workflows in QMS300 ensures that no product ships without full quality review.
- Configure lot status codes in MMS080 with mandatory QA review gates before status transitions from quarantine to released
- Set up forward and backward lot traceability in MMS080/MMS081 linking finished goods to raw material supplier lots
- Enable batch record printing through PMS230 with operator sign-off fields for each manufacturing step
- Define lot sampling plans in QMS300 based on AQL tables and skip-lot inspection rules per supplier qualification level
Validation Documentation and Computer System Validation
Pharma regulatory bodies require Computer System Validation (CSV) for any system controlling GMP processes. M3 implementations in pharma require IQ/OQ/PQ documentation, validated report outputs, and change control procedures. The validation scope covers configured programs, custom scripts in M3 MEC (Metadata Publisher), and integrations with LIMS and serialization systems.
- Document all M3 configuration parameters in IQ/OQ/PQ validation protocols covering item master, formulas, and quality modules
- Validate M3 report outputs in RMS001 against regulatory requirements for batch records, COAs, and deviation reports
- Establish change control procedures in M3 using version-controlled product structures in PDS001 with effective dates
- Configure integration validation between M3 and external LIMS systems through M3 API/MEC ensuring data integrity checks
Ensure your M3 pharma setup meets FDA and GMP requirements. Contact Netray for compliance-focused M3 consulting.
Related Resources
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