Move batch records, quality approvals and supplier agreements off paper and into controlled digital workflows, with the electronic signatures and audit trails GMP inspections expect.
Pharmaceutical document workflow automation replaces paper and hybrid GMP records with controlled electronic workflows. Batch records, deviations, CAPAs, change controls and supplier agreements are created, routed, reviewed, signed and archived in one system. Every action is attributable and time-stamped, which shortens review cycles and makes records easier to retrieve during an inspection. That is what most teams look for when they evaluate pharmaceutical document management software.
MSB Docs is GMP software for the document and signature layer of these workflows: electronic batch manufacturing records (eBMR), e-signatures configured for 21 CFR Part 11, Smart Forms, contract lifecycle management and, for India, eStamp Paper. It works alongside your QMS, MES, and ERP rather than replacing them.
Where paper still slows pharmaceutical operations
Most plants have digitized planning and inventory, but many of the records that release a batch or close to a quality event still move on paper. Each handoff adds a wait, a chance of a transcription error, and a gap in the audit trail. These handoffs are where paperless manufacturing in pharma has to start.
Batch records and release
A batch can finish on the line days before its record is ready for release. QA reviewers check every page for missing entries, late corrections and unsigned steps, then send pages back for rework. The longer the record, the longer the queue is.
Deviations, CAPAs and change controls
Investigations, CAPA plans, effectiveness checks and change controls each need several reviewers and approvers. When those approvals move by email attachment or printed copy, quality events stay open and overdue lists grow.
Supplier and quality agreements
Quality agreements, confidentiality agreements and CMO contracts pass through legal, quality and procurement before signature. In India they may also need stamp duty paid before execution, which adds another physical step.
SOPs, training and acknowledgements
New and revised SOPs need approval, then read-and-understood sign-off from every trained user. Tracking those signoffs on paper weakens document control in the pharmaceutical industry, where you must be able to prove who was trained on which version, and when.
Unsure where to begin? Schedule a demo and let us help map your most challenging document workflows.
Pharmaceutical workflows MSB Docs digitizes
Electronic batch manufacturing records (eBMR)
Manage the full batch manufacturing record (BMR) lifecycle in one place: master batch record setup, batch creation, execution documentation, quality review, approval and e-signature, then closure and archival. Structured records and review by exception let QA focus on flagged entries instead of re-checking every line.
Quality documentation approvals
Route deviation and OOS/OOT investigations, CAPA plans and effectiveness checks, risk assessments and change controls to the right reviewers. Each approval is signed electronically, tied to a verified user, a timestamp and the meaning of the signature, and kept with a complete history.
Supplier and quality agreements
Draft quality agreements, CDAs and supplier contracts from approved templates and a central clause library. Route them by contract type or role, sign them electronically, and get reminders before renewals and expiries. In India, eStamp Paper lets you pay stamp duty digitally before execution, and eKYC verifies who is signing.
GMP forms and acknowledgements
Replace paper checklists, logbooks, and SOP acknowledgements with mobile friendly Smart Forms. Conditional fields show each user only what applies to them, and approval steps and e-signatures are built in.
Built for regulated electronic records
Pharmaceutical records are governed by the predicate of rules that require them, and by the rules that decide when an electronic version can replace paper. Those rules set the standard for data integrity in pharma and for any electronic signature in the pharmaceutical industry. MSB Docs is designed to support these requirements. Meeting them also depends on your validation of the system for its intended use, your SOPs, and your training records.
| Requirement | What it covers | How MSB Docs supports it |
|---|---|---|
| FDA 21 CFR Part 11 | When electronic records and signatures are treated as equivalent to paper and handwritten signatures | Audit trails, role-based access, attributable electronic signatures, controlled records. See the Part 11 control mapping |
| 21 CFR 211.188 | Contents of batch production and control records for finished pharmaceuticals | eBMR captures execution entries, reviews and approvals in one controlled record |
| EU GMP Annex 11 | Computerized systems used in GMP activities: validation, data, audit trails, security, e-signatures, batch release | eBMR and e-signature controls mapped on the eBMR page. The 2011 text applies; a revised draft was consulted in 2025 |
| ALCOA+ | Data that is attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring and available | Every entry and signature is tied to a user and time, with change history |
New to the rules? Read the 21 CFR Part 11 guide and the EU GMP Annex 11 guide.
How MSB Docs fits with your QMS, MES and ERP
MSB Docs is the record, approval, and signature layer around the systems you already run. It does not replace them.
| System | What it does | Where MSB Docs fits |
|---|---|---|
| MES | Executes and sequences shop-floor operations | eBMR manages the controlled batch record, reviews and signatures around that execution |
| QMS | Manages quality events and their lifecycle | MSB Docs routes and signs the documents those events produce |
| ERP | Plans materials, orders and inventory | Signing and approval workflows can start from, and return status to, business systems |
| DMS / repositories | Stores controlled documents | Signed records and audit trails are kept in MSB Docs’ repository, or sent to your existing repository |
MSB Docs lists integrations including SAP, Oracle, Documentum, SharePoint, Microsoft 365, Google Workspace, Salesforce and AWS, and offers an API for custom workflows.
Built for every type of pharmaceutical manufacturer
Contract manufacturers (CDMOs and CMOs)
CDMOs run the same batch and quality workflows for many sponsors, each with its own quality agreement and approval expectations. Keeping every client’s records, reviews and signatures in controlled workflows makes sponsor audits easier to prepare for.
API and bulk drug manufacturers
API production generates long batch records, frequent in-process checks, and many supplier documents. Electronic batch records and routed approvals reduce the review load on QA and support the documentation expectations of ICH Q7.
Indian manufacturers supplying the US and EU
Plants that export must satisfy Indian rules (including revised Schedule M) as well as FDA and EU GMP expectations. MSB Docs combines Part 11-configured e-signatures and eBMR with India-specific tools: eStamp Paper and Aadhaar-based eSign.
Biopharma and biologics
Biologics processes involve more steps, more in-process data, and more reviewers per batch. Structured electronic records help keep complex batches complete and reviewable.
Quality assurance teams
QA carries the review load for every one of these workflows. Review by exception, routed approvals and a single audit trail per record let reviewers spend time on the entries that need judgement.
Validation support and deployment
Adopting a new system in a GxP environment means validating it for its intended use. MSB Docs supports that work:
- Validation documentation to support your computer system validation.
- Data residency and hosting options to meet regional and corporate data requirements.
- Role-based access and document controls, with complete audit trails for every signature.
- Training, hyper care and 24/7 support during and after go-live.
- Independently audited security: SOC 2 Type II, ISO 27001 and ISO 9001.
Request the validation package
Results from pharmaceutical customers
Zydus Lifesciences: quality and regulatory documentation. Zydus used MSB Docs eSignature, configured for 21 CFR Part 11, to digitize investigations, CAPA and effectiveness checks, risk assessments and change controls. It reports 70% faster approvals, with 100% traceable records and paper-free execution. Read the Zydus case study
Pfizer: regulated R&D signatures. Pfizer replaced the international shipping of documents for wet-ink signatures with digital signatures on electronic lab notebooks and regulated documents, so several signers can approve without waiting on couriers. Read the Pfizer case study
GSK: regulatory compliance workflows. GSK uses MSB Docs for e-signatures in regulated documentation workflows. Read the GSK case study
Glenmark: documentation signing. Glenmark simplified signing across its documentation processes with MSB Docs eSignature. Read the Glenmark case study
Implementation considerations
Most teams start with one high-friction workflow, prove it, then extend.
- Pick one workflow. Quality approvals often come first, because they need no shop-floor change and show results quickly.
- Map roles and signature meanings. Decide who authors, reviews and approves, and what each signature means (for example “reviewed” or “approved”).
- Configure templates and routing. Build the forms, master records or contract templates, and the approval paths.
- Validate for intended use. Run your risk-based validation, supported by vendor documentation, and update your SOPs.
- Pilot, then extend. Run one product line or department, review the results, then add workflows such as eBMR or supplier agreements.
Frequently asked questions
Can GMP records be signed electronically?
Yes, when the system and your procedures meet 21 CFR Part 11 (US) or EU GMP Annex 11 (EU). Signatures must be attributable to one person, show the signer’s name, date, time, and meaning, and be permanently linked to the record.
Does using MSB Docs make Part 11 compliant?
No software does that on its own. MSB Docs provides technical controls such as audit trails, access control and attributable signatures. You still validate the system for its intended use, maintain SOPs and training, and send FDA the certification required for electronic signatures.
What is the difference between eBMR and MES?
An MES executes and sequences shop-floor operations. MSB Docs eBMR manages the controlled batch record around that execution: its entries, reviews, signatures and archives. Some plants run both. Others use eBMR where a full MES isn’t justified.
Will MSB Docs replace our QMS?
No. MSB Docs routes and signs the documents your quality events produce, such as investigation reports, CAPA plans and change controls, and keeps their audit trail.
Which workflow should we digitize first?
Usually, the one with the longest approval queue and the fewest system dependencies. For many plants that are deviation and CAPA approvals; for others, supplier agreements.
Start with the workflow that slows you most
Tell us which records hold up your batches, quality events or supplier onboarding. We’ll show how they would run in MSB Docs and what validation it would involve.
