Life sciences manufacturers — pharmaceuticals, medical devices, nutraceuticals, and biotechnology companies — face some of the most stringent regulatory requirements in any industry. SAP Business One, properly configured, provides the ERP foundation these companies need to maintain compliance while operating efficiently and profitably.
Regulatory Compliance Framework
Electronic Batch Records
SAP Business One's production module can be configured to capture complete electronic batch records that meet cGMP documentation requirements.
Lot Genealogy and Traceability
Life sciences manufacturers must maintain complete forward and backward traceability at the lot level. SAP Business One provides full lot genealogy from raw material receipt through finished goods distribution.
- Vendor lot to internal lot mapping: Link supplier CoA data to receiving inspection records
- In-process lot tracking: Maintain chain of custody through every production step
- Expiry and retest date management: Track stability data and enforce expiry controls
- Distribution records: Complete customer and lot linkage for product recalls
- Sample and retain management: Track retention samples per regulatory requirements
Validation and Computer System Assurance
GAMP 5 Compliance
SAP Business One implementations in regulated environments must follow GAMP 5 (Good Automated Manufacturing Practice) guidelines. This includes risk-based validation, documented testing protocols, and ongoing system maintenance procedures. Synesis delivers full validation documentation packages as part of every life sciences implementation.
Quality Management Integration
Document Control
Version-controlled SOPs, work instructions, and specifications integrated with SAP master data and production processes.
Deviation Management
Track, investigate, and resolve deviations with full audit trail and CAPA linkage within SAP Business One.
Complaint Handling
Customer complaint intake, investigation, and resolution tracking with automatic adverse event reporting triggers.
Supplier Qualification
Approved supplier list management, qualification status tracking, and periodic re-evaluation scheduling.
Life Sciences Expertise
Synesis International understands the unique demands of life sciences manufacturing. Our team has implemented validated SAP Business One systems for pharmaceutical, medical device, and biotech companies, delivering compliant solutions that support both regulatory requirements and operational excellence.
