Why work with Synesis International to implement BPA?

Synesis International has been a Preferred BPA Solution Provider for 20 years. Our team has implemented BPA Quality 365 and BPA Medical 365 across regulated and non-regulated industries — translating ISO 9001, ISO 13485, FDA 21 CFR Part 11, IATF 16949, and AS9100 requirements into working BPA configurations. We deliver discovery, configuration, validation, training, and ongoing optimization from our Greenville, SC headquarters.

Does BPA Quality Management require Microsoft 365?

Yes. BPA is built natively on Microsoft 365 and SharePoint. It runs inside your existing Microsoft 365 tenant, uses SharePoint for document storage, Teams for collaboration, Power Automate for workflow, and Power BI for reporting. Your data stays in your Microsoft tenant — you own it, you control it, and BPA never moves it to a third-party cloud.

What standards does BPA Quality Management support?

BPA supports ISO 9001:2015, ISO 13485, ISO 14001, ISO 27001:2022, ISO 45001, IATF 16949, AS9100, FDA 21 CFR Part 11, FDA 21 CFR Part 820, EU GMP Annex 11, and other regulated frameworks. BPA Solutions itself is ISO 27001:2022 certified — the certification was achieved using BPA's own eQMS, demonstrating the platform's effectiveness.

How long does a BPA implementation take?

A typical Synesis-led BPA implementation runs 8 to 16 weeks depending on scope, number of modules, and validation requirements. Manufacturing deployments using BPAQuality365 with document control, CAPA, audits, and nonconformance can go live in 8 weeks. Regulated life sciences deployments using BPAMedical365 with IQ/OQ/PQ validation typically take 12 to 16 weeks.

BPA Quality Management — Microsoft 365 eQMS

Q: What is BPA Quality Management?

BPA Quality Management (BPAQuality365) is the #1 eQMS software powered by Microsoft 365 and SharePoint. Developed by BPA Solutions SA, it delivers document control, CAPA, audits, nonconformance, risk, training, supplier, equipment, change, process, and health & safety management as a single integrated platform. Synesis International is a Preferred BPA Solution Provider and Premier Partner with 20 years of BPA implementation experience across manufacturing, pharma, medical, food, energy, and chemical industries.

Intelligent Quality on the Microsoft Platform You Already Own

BPA Quality Management — known as BPAQuality365® — is the #1 eQMS software powered by Microsoft 365, SharePoint, and AI. Built by BPA Solutions SA and trusted by 200+ delighted customers across more than 50 countries, BPA delivers document control, CAPA, audits, nonconformance, risk, training, supplier, equipment, change, process, and health & safety management as a single integrated platform that runs natively inside your Microsoft 365 tenant. Your data stays in SharePoint. Your users work in Teams. Your IT keeps a stack they already know.

Synesis International has been a Preferred BPA Solution Provider for 20 years — one of the longest-tenured BPA implementation partners in the Americas. From Greenville, SC, our team has delivered BPAQuality365 and BPAMedical365 across manufacturing, pharma and medical device, food and beverage, chemical, energy, and professional services organizations. We translate ISO 9001, ISO 13485, FDA 21 CFR Part 11, IATF 16949, and AS9100 requirements into working BPA configurations — and we stay engaged for ongoing optimization, training, and audit support.

Two complementary platforms. BPAQuality365® for quality and risk management in manufacturing, energy, food, chemical, and services. BPAMedical365® for medical device, pharma, and biotech compliance — including validated workflows for FDA 21 CFR Part 11, EU GMP Annex 11, and ISO 13485 requirements.

BPA Platform Modules

BPAQuality365 is a tightly integrated set of 12 quality modules — one data model, one audit trail, one SharePoint tenant. Every record raised in one module creates traceable links across the others. A nonconformance escalates to CAPA; a change request creates document revisions and training assignments; an audit finding flows directly into corrective action. No silos. No duplicated user identity. No third-party data store.

Document Control

Full document lifecycle on SharePoint with version control, approval workflows, electronic signatures, distribution, and read-and-understand tracking. ISO 9001 and FDA 21 CFR Part 11 ready.

CAPA Actions

Corrective and preventive actions with structured root cause analysis, action tracking, effectiveness verification, and closure approval. Linked to source nonconformances, audits, and complaints.

Non-Conformance Management

Capture product, process, material, and documentation NCs with containment, disposition, root cause, and escalation to CAPA. Mobile capture from the plant floor via Teams and Power Apps.

Audit Management

Plan, schedule, and execute internal, supplier, process, and regulatory audits. Configurable checklists, finding documentation with severity, and automatic CAPA escalation.

Training & Competency

Competency matrix by role, automatic training assignment on document revisions, completion tracking, retraining cycles, and audit-ready evidence linked to every controlled document.

Risk Management

Enterprise risk register with severity, occurrence, and detection scoring, RPN calculation, heatmaps, mitigation plans, and periodic review. ISO 31000 aligned.

Change Management

Formal review and approval for process, product, equipment, and system changes. Cross-functional impact assessment with linked document, training, and validation updates.

Supplier Management

Supplier master, qualification, approved supplier list, scorecards, SCARs, and audit cycles. Captures every supplier-driven NC and CAPA back to the source.

Equipment Management

Asset register, calibration schedules, maintenance history, certificates of calibration, and out-of-tolerance investigations linked to nonconformance and CAPA.

Process Management

Map and govern business processes with owner accountability, KPIs, and linked work instructions. Drives the process approach required by ISO 9001 §4.4.

Complaints & Feedback

Centralized intake for customer complaints and quality feedback with investigation, response, and automatic escalation to nonconformance and CAPA.

Health, Safety & Environment

Incident reporting, near-miss tracking, environmental aspects, and information security management. Supports ISO 14001, ISO 45001, and ISO 27001 programs.

Q-Pilot — BPA's Generative AI for Quality

BPA's Q-Pilot brings generative AI directly into the eQMS — assisting with root cause analysis, summarizing nonconformances, drafting CAPA action plans, suggesting risk mitigations, and generating audit report narratives. Q-Pilot runs on Microsoft's enterprise AI stack inside your tenant, so quality data never leaves your governance boundary.

AI Root Cause

Q-Pilot reads NC and CAPA records, proposes 5-Why and Fishbone analyses, and recommends corrective actions based on history.

Audit Narratives

Drafts audit reports, finding summaries, and management review narratives from raw audit data — auditor reviews and approves.

Document Drafting

Generates initial drafts of SOPs, work instructions, and procedures based on prompts and existing controlled documents.

Risk Insights

Surfaces emerging risk patterns from accumulated NC, audit, and supplier data and proposes mitigation actions.

Why a Microsoft 365 Native eQMS Matters

BPA does not bolt on Microsoft 365 — it is a Microsoft 365 application. That changes the economics, security, and adoption curve of an eQMS in three concrete ways.

Your Data Stays Yours

SharePoint Storage

Every document, record, and signature lives in your own SharePoint tenant. No third-party cloud, no vendor data lake, no exit cost. Your Microsoft compliance posture covers your eQMS automatically.

Microsoft-Grade Security

MFA, Encryption, Conditional Access

Multi-factor authentication, end-to-end encryption, conditional access, and Microsoft Defender all apply to BPA out of the box. Microsoft 365 MFA blocks 99% of identity attacks before they reach quality data.

Teams-First Adoption

Where Work Already Happens

Users approve documents, log NCs, complete training, and respond to audit findings from inside Microsoft Teams. No new app to learn. Adoption rates jump because the eQMS shows up where work already lives.

Power Automate Workflows

Configurable, Not Hard-Coded

Approval routes, escalations, and notifications use Power Automate. Quality administrators configure their own workflows — no developer ticket required. BPA ships pre-built templates that Synesis tailors to your process.

Power BI Reporting

Drillable Quality KPIs

BPA ships Power BI templates for management review, CAPA aging, audit performance, supplier scorecards, and document compliance. Every KPI drills to the source record. Your data, your reports, your governance.

Cost-Effective at Scale

No Per-User eQMS License

BPA prices by tenant, not by named user. Every Microsoft 365 user in your organization can use the eQMS at no incremental license cost — so quality stops being something only the quality team can touch.

20 Years as Your Preferred BPA Solution Provider

Synesis International has implemented BPA Quality 365 and BPA Medical 365 for 20 years — making us one of the longest-tenured BPA Premier Partners in the Americas. We are not a generalist consultancy that learned BPA last quarter. We are a BPA-focused practice with deep expertise in document control, validation, regulated industry deployments, SharePoint architecture, and Microsoft 365 governance.

20 Years of BPA Experience

Continuous BPA partnership since the platform's early SharePoint releases. We have lived every major BPA generation and migration.

Preferred Solution Provider

Recognized by BPA Solutions SA as a Preferred Solution Provider and Premier Partner. Direct escalation path to BPA engineering.

Discovery to Go-Live

Process mapping, gap analysis, BPA configuration, SharePoint architecture, validation packs, training, hypercare, and ongoing optimization.

Regulated Industry Validation

IQ, OQ, PQ packages for FDA 21 CFR Part 11 and EU GMP Annex 11 environments. Validation deliverables ready for FDA, MHRA, and notified body inspection.

SAP Business One Integration

As a SAP Gold Partner and BPA Premier Partner, Synesis is uniquely positioned to integrate BPA with SAP Business One — suppliers, items, inspections, and nonconformances flowing both ways.

US-Based Support

Greenville, SC headquarters. Eastern Time delivery. English-speaking, US-based consultants who know American manufacturing and regulatory expectations.

Standards & Regulatory Coverage

BPA is built to support the standards that regulated manufacturers actually face — and BPA Solutions SA itself is ISO 27001:2022 certified, with the certification achieved using BPA's own eQMS. That is the platform's strongest possible reference.

ISO 9001:2015

Quality Management Systems. Document control, CAPA, internal audits, management review, and continuous improvement.

ISO 13485

Medical devices. Design control, risk management, complaint handling, and validated workflows ready for notified body audit.

ISO 27001:2022

Information security. BPA Solutions is itself ISO 27001 certified, achieved using BPA's own platform — the strongest possible reference for the product.

FDA 21 CFR Part 11

Electronic records and electronic signatures. Audit trails, access controls, and validated workflows for FDA-regulated environments.

IATF 16949 & AS9100

Automotive (APQP, PPAP, supplier quality) and aerospace (configuration management, FOD, counterfeit parts) deployments supported.

ISO 14001 & ISO 45001

Environmental management and occupational health & safety integrated through the Health, Safety & Environment module.

Industries Served

BPA is trusted by 200+ customers across more than 50 countries. Synesis has implemented BPA across the full range of regulated and non-regulated industries — each with its own compliance profile, validation depth, and workflow customization.

Manufacturing

Discrete and process manufacturers using BPA for document control, supplier quality, NCR/CAPA, audits, and IATF 16949 or ISO 9001 compliance.

Pharma, Biotech & MedTech

BPAMedical365 deployments for medical device, pharmaceutical, and biotech firms — with validated workflows for FDA 21 CFR Part 11 and EU GMP Annex 11.

Food & Beverage

HACCP, SQF, BRC, and FSSC 22000 deployments with document control, supplier qualification, traceability, and inspection workflows.

Chemical

Process safety management, change control for hazardous materials, environmental aspects tracking, and Responsible Care compliance.

Energy & Utilities

Asset-intensive operations using BPA for equipment management, inspections, regulatory documents, and safety incident management.

Professional Services

Engineering, consulting, and managed-services firms using BPA for ISO 9001 and ISO 27001 management systems on Microsoft 365.

The Synesis BPA Implementation Approach

A BPA deployment is not just software installation — it is a quality system redesign with a Microsoft 365 foundation. Our five-phase approach has been refined across 20 years of BPA projects.

1. Discovery

Process mapping, current-state assessment, regulatory gap analysis, and SharePoint architecture review. Output: implementation blueprint.

2. Configuration

BPA module setup, taxonomy design, workflow tailoring, role and permission model, and SharePoint site provisioning.

3. Validation (if required)

URS, FS, IQ, OQ, PQ packages for FDA and EU GMP environments. Test scripts, traceability matrix, and validation summary report.

4. Training & Go-Live

Role-based training, train-the-trainer sessions, data migration, parallel run, cutover, and on-site or remote go-live hypercare.

5. Optimization

Quarterly health checks, BPA version upgrades, new module rollouts, AI feature adoption, and continuous improvement coaching.

BPA Quality Management