Electronic Records That Prove Compliance

The purpose of device history and batch records is simple. They must prove that every unit or lot was made as intended, with the right materials, steps, limits, and approvals. Paper makes that hard. Values get copied late, signatures go missing, and QA finds issues days after the work is done. Electronic device history records and electronic batch records fix both the mechanics and the timing. They collect data at the point of work, link signatures to the exact step and content, and preserve a tamper-evident audit trail. This is exactly what 21 CFR Part 11 asks for when it describes trustworthy electronic records and signatures that are equivalent to paper and handwritten signatures (Electronic Code of Federal Regulations, 2025; U.S. Food and Drug Administration, 2018).

Opcenter Execution is Siemens’ MES for discrete, process, electronics, and semiconductor operations. It guides the operator through each step, enforces specifications and limits, captures results with context such as lot, tool, and operator, and applies electronic signatures with proper manifestations and linkages. Each result is stored with who, what, when, where, and why, which is the evidence QA needs during release and investigations (Siemens Digital Industries Software, n.d.). For medical devices, Opcenter helps meet the device history record requirements in 21 CFR 820.184 by recording dates, quantities, equipment, and significant results, all tied to the work order and the device master record it must match (Electronic Code of Federal Regulations, 2025). For pharma and biotech, Opcenter supports electronic batch record patterns that align to GMP and to EU Annex 11 expectations for validation, security, and data controls (European Commission, 2011).

Compliance is not only about product features. It is about process and evidence that stand up to inspection. FDA’s Part 11 guidance emphasizes a risk based approach to validation and controls. It advises teams to focus on functions that affect product quality and data integrity, to maintain audit trails, to link signatures to records, and to manage accounts and training with care (U.S. Food and Drug Administration, 2018). ISPE’s GAMP 5 Second Edition gives a common language for this work, including critical thinking about risk, supplier assessment, and scalable testing that fits modern software and cloud (International Society for Pharmaceutical Engineering, 2022). The companion GAMP Records and Data Integrity guide explains how to protect data across its life cycle, which is why many QA groups use it when they design SOPs for creation, review, reporting, retention, and archival of eDHR and eBR (ISPE, 2017).

Security and continuity complete the picture. ISO 27001 lays out the information security management system that protects identity, access, logging, and change in the environment that hosts Opcenter. ISO 22301 adds a tested continuity plan so backups and recovery are proven rather than improvised during an incident. ISO 9001 provides the familiar backbone for document control, change control, and internal audits that anchor validation and ongoing checks for the e-record process (International Organization for Standardization, 2022; International Organization for Standardization, 2019; International Organization for Standardization, 2015). Together, these standards turn good intentions into daily practice.

Three pains usually push teams to move now. 

1. Record preparation and review consume days. QA staff spend hours reconciling dates, deciphering handwriting, and checking specifications across paper packets. Review by exception flips the effort. The system flags only out-of-limits values, missing steps, or changed entries, which reduces overall time and turns patterns into trends that can be fixed (BioPharm International, 2019; EY, 2023).
2. Missing signatures and late entries create audit risk. Part 11 requires signature manifestations and explicit linkage between a signature and the exact record. Opcenter applies the signature ceremony at the right moment and logs the result. MHRA’s data integrity guidance stresses contemporaneous entry and attributable records, both supported by eDHR and eBR by design (U.S. Food and Drug Administration, 2018; Medicines and Healthcare products Regulatory Agency, 2018).
3. Device and batch genealogy are hard to trace. The device history rule in 21 CFR 820.184 expects a record that proves conformance to the device master record. Opcenter captures equipment, materials, and labels for each order, which is why investigators can answer the where used question quickly during a complaint or recall (Electronic Code of Federal Regulations, 2025; Siemens Digital Industries Software, n.d.).

Ask This → Get That: Live Opcenter Examples

1. Ask: What steps must be signed, and by whom, for a compliant record.
   Get: a signature matrix in Opcenter that maps each operation to the signer role and signature meaning. Configure signature manifestations and the audit trail so each signature is printable with the record, which satisfies Part 11 linkage expectations (Electronic Code of Federal Regulations, 2025; U.S. Food and Drug Administration, 2018).
   Screenshot idea: the signature matrix and an execution screen with the signature dialog.
   Alt text: “Operation screen showing limits, result entry, and signature prompt tied to the step.”
   
   
2. Ask: Where do we lose most time during review.
   Get: review by exception criteria and dashboards. Define rules that flag out-of-spec values, skipped steps, late entries, or changed results. QA reviews exceptions during the shift rather than after the batch, which several sources report reduces review time materially (BioPharm International, 2019; AspenTech, 2023).
   GIF idea: exception list filtered by order and resolver.
   Alt text: “Exception list showing three issues, each linked to the underlying step and value.”
   
   
3. Ask: What do we need to validate and how much.
   Get: a risk based validation plan that reuses supplier testing, focuses on critical functions, and scales with change. Use GAMP 5 Second Edition for approach and the GAMP data integrity guide for life cycle controls. Tie change control and training to ISO 9001 routines so the program is sustainable and auditable (International Society for Pharmaceutical Engineering, 2022; ISPE, 2017; International Organization for Standardization, 2015).
   
   
4. Ask: How do we protect records if systems fail.
   Get: a continuity plan that aligns RTO and RPO with quality risk. ISO 22301 provides the test cadence and evidence, while ISO 27001 governs backup access and restoration checks. Run restore drills and keep short reports as quality records because availability is part of integrity (International Organization for Standardization, 2019; International Organization for Standardization, 2022).
   
   
5. Ask: How do we integrate with ERP and QMS without breaking traceability.
   Get: contract first events for order release, operation complete, and quality result that include stable identifiers. Validate migrations with reconciliation routines and documented acceptance criteria so records remain complete and attributable across systems (U.S. Food and Drug Administration, 2018; International Society for Pharmaceutical Engineering, 2022).

Proof that this works is visible in public cases and trade studies. Reported results include very large cuts in order preparation time and significant reductions in review time once teams adopt review by exception and electronic records. One published case shows order preparation time cut by ninety five percent and review time reduced by more than half after moving to eBR with integrated systems. The common pattern is real time capture, clear exception rules, and fewer manual checks, which is the design Opcenter supports (AspenTech, 2023; BioPharm International, 2019; A3P Association, 2021; EY, 2023). 

A 90 day plan gets you from intent to proof. 

• Days 1 to 10. Define scope, draft the signature matrix, list critical records, and map current pain points. Agree on target KPIs such as time to prepare, time to review, exception count, and on time release. 
  
  
• Days 11 to 30. Configure the first workflow in Opcenter, enable signatures and audit trails, and load master data for one product family. Write exception rules and build a simple dashboard.
  
  
• Days 31 to 60. Run with production. QA reviews exceptions each shift. Collect feedback, tune limits, and harden the procedure. Draft the validation plan using GAMP 5 principles, reuse supplier evidence, and execute the most critical tests first (International Society for Pharmaceutical Engineering, 2022; ISPE, 2017). 
  
  
• Days 61 to 90. Connect to ERP and QMS for the core events, perform a documented reconciliation on a small data set, and complete a backup and restore test. Hold a brief internal audit using ISO 9001 and ISO 27001 checklists. Publish a short win report and decide where to expand next (International Organization for Standardization, 2015; International Organization for Standardization, 2022). 

Mini FAQ

References

• A3P Association. (2021). Electronic batch record: Opportunities and pitfalls to avoid. https://www.a3p.org/en/electronic-batch-record/
  This article is relevant because it summarizes benefits such as reduced review and release time with practical cautions for implementation. It covers review by exception and early review while production is ongoing. Two takeaways are that earlier QA engagement shortens release and that workflow clarity prevents bottlenecks.
  
  
• AspenTech. (2023). GlaxoSmithKline speeds up batch release time: A study in digital transformation. https://www.aspentech.com/en/resources/case-studies/glaxosmithkline-speeds-up-batch-release-time-a-study-in-digital-transformation
  This case is relevant because it provides quantified improvements in preparation and review time after moving to electronic records. It describes integration with plant systems and review by exception. Two takeaways are that real time capture removes retyping and that structured exception handling halves review time in the example.
  
  
• BioPharm International. (2019). Review by exception: Connecting the dots for faster batch release. https://www.biopharminternational.com/view/review-exception-connecting-dots-faster-batch-release
  This article is relevant because it explains review by exception and reports typical time savings for batch report preparation and review. It covers common pain points and how electronic records reduce manual steps. Two takeaways are that exception-driven review cuts non value added checks and that trends become visible quickly.
  
  
• Electronic Code of Federal Regulations. (2025). 21 CFR Part 11 Electronic records; electronic signatures. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-11
  This source is relevant because it is the operative regulation for electronic records and signatures in FDA-regulated contexts. It covers controls for closed systems, signature manifestations, and signature to record linking. Two takeaways are that linkage is mandatory and that controls must make e-records as trustworthy as paper.
  
  
• Electronic Code of Federal Regulations. (2025). 21 CFR 820.184 Device history record. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-820/subpart-M/section-820.184
  This section is relevant because it defines what a device history record must contain for each batch, lot, or unit. It covers dates, quantities, equipment, results, and labeling. Two takeaways are that eDHRs must demonstrate conformance to the device master record and that records must be retained per Part 820.
  
  
• European Commission. (2011). EU GMP Annex 11: Computerised systems. https://health.ec.europa.eu/system/files/2016-11/annex11_01-2011_en_0.pdf
  This annex is relevant because it outlines expectations for validation, data, security, and change control for computerized systems in GMP. It covers risk management, audit trails, and data migration. Two takeaways are that validation must be documented and that data integrity controls must follow the full life cycle.

• (2023). Electronic batch records improve pharma manufacturing. https://www.ey.com/en_us/insights/life-sciences/electronic-batch-records-improve-pharma-manufacturing
  This piece is relevant because it explains the operational impact of electronic batch records and review by exception. It covers efficiency, paper elimination, and trending of exceptions. Two takeaways are that exception-based QA reduces review load and that digital records speed release decisions.

• International Organization for Standardization. (2015). ISO 9001:2015 Quality management systems: Requirements. https://www.iso.org/standard/62085.html
  This standard is relevant because it provides change control, document control, and audit routines that anchor validation and ongoing checks. It covers the requirements for an effective QMS that supports regulated records. Two takeaways are that process ownership sustains e-record quality and that internal audits keep controls effective.
  
  
• International Organization for Standardization. (2019). ISO 22301:2019 Security and resilience: Business continuity management systems: Requirements. https://www.iso.org/standard/75106.html
  This standard is relevant because e-records must survive incidents and be recoverable within defined time objectives. It covers planning, testing, and improving continuity capabilities. Two takeaways are that tested recovery protects release timelines and that continuity is part of data integrity.
  
  
• International Organization for Standardization. (2022). ISO/IEC 27001:2022 Information security management systems: Requirements. https://www.iso.org/standard/27001
  This standard is relevant because access control, logging, and change management keep e-records secure and attributable. It covers the management system for information security that auditors recognize. Two takeaways are that governance complements technical controls and that supplier environments need the same discipline.
  
  
• International Society for Pharmaceutical Engineering. (2022). GAMP 5 Guide, 2nd Edition. https://ispe.org/publications/guidance-documents/gamp-5-guide-2nd-edition
  This guide is relevant because it provides the risk-based validation approach most auditors expect for computerized systems. It covers critical thinking, supplier assessment, and scalable testing. Two takeaways are that validation effort should match risk and that supplier evidence reduces duplicate testing.
  
  
• ISPE. (2017). GAMP Guide: Records and Data Integrity. https://ispe.org/publications/guidance-documents/gamp-records-pharmaceutical-data-integrity
  This guide is relevant because it explains data integrity controls across the record life cycle. It covers roles, risk controls, and example measures for creation, processing, review, reporting, and archival. Two takeaways are that life cycle thinking prevents gaps and that practical controls are more sustainable than exhaustive ones.
  
  
• Medicines and Healthcare products Regulatory Agency. (2018). GxP data integrity guidance and definitions. https://assets.publishing.service.gov.uk/media/5aa2b9ede5274a3e391e37f3/MHRA_GxP_data_integrity_guide_March_edited_Final.pdf
  This guidance is relevant because regulators expect records to be attributable, legible, contemporaneous, original, and accurate. It covers expectations for electronic systems and procedural controls. Two takeaways are that contemporaneous entry is essential and that audit trails must be reviewed.
  
  
• Siemens Digital Industries Software. (n.d.). Opcenter Execution (MES) portfolio. https://plm.sw.siemens.com/en-US/opcenter/execution/
  This page is relevant because it describes how Opcenter Execution enforces steps and signatures and captures the data that forms eDHR and eBR. It covers industry variants and integration patterns. Two takeaways are that enforcement reduces errors and that connected records speed investigation.
  
  
• Siemens Digital Industries Software. (2025). Electronic device history records (eDHR) technology explainer. https://www.sw.siemens.com/en-US/technology/electronic-device-history-records-edhr/
  This explainer is relevant because it outlines eDHR concepts and how real time error proofing and traceability improve medical device quality. It covers integration with broader quality processes. Two takeaways are that eDHR eliminates paper delays and that linking quality workflows to execution accelerates closure.
  
  
• U.S. Food and Drug Administration. (2018). Part 11, electronic records; electronic signatures: Scope and application [Guidance]. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/part-11-electronic-records-electronic-signatures-scope-and-application
  This guidance is relevant because it clarifies FDA’s current thinking on Part 11 controls and risk-based validation. It covers audit trails, signature controls, and practical testing expectations. Two takeaways are that focus should be on quality impacting functions and that signature to record linkage is essential.
  
  
• World Wide Web Consortium. (2023). Web Content Accessibility Guidelines (WCAG) 2.2. https://www.w3.org/TR/WCAG22/
  This guideline is relevant because dashboards and records must be readable by everyone. It covers text alternatives, contrast, and structure for accessible content. Two takeaways are that concise alt text supports assistive tech and that contrast and labels help all readers.