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One myth has dominated the pharmaceutical manufacturing industry for years. If you want review by exception, you need an Enterprise MES. Enterprise MES with EBR can enforce SOPs natively, capture data directly from integrated equipment,
apply hard-stop controls when operators attempt out-of-bounds actions, and make automated exception review structurally possible in a way that paper never could. But, such an implementation also requires up to 2 years of time and millions of dollars in capital.
This is the primary reason why manufacturers without the capital or timeline for full-stack MES deployment believe that review by exception is not for them. In this video, we’ll burst this myth and tell you three pathways to achieve review by exception,
each designed for a different stage of maturity. 1. Document Review Automation. This pathway is for paper-dependent operations and virtual pharmaceutical sponsors. DRA platforms use pharmaceutical-tuned models, not generic OCR, to ingest unstructured paper
or PDF batch records, automatically extract and classify critical data values, and run algorithmic exception checks against predefined parameters. Because DRA operates sponsor-side, it delivers structured, queryable data and automated exception review without requiring any changes to the CDMO’s systems.
Because DRA operates sponsor-side, it delivers structured, queryable data and automated exception review without requiring any changes to the CDMO’s systems. The CDMO continues to send records in its current format. The sponsor’s DRA system transforms them into relational, auditable data.
2. Composable MES. This is the pathway for mid-maturity operations, CDMOs managing high-mix, multi-client production, and mid-market manufacturers moving beyond paper-based data capture. Composable MES platforms are cloud-native, modular systems that let process
engineers build individual digital applications – electronic logbooks, dynamic work instructions, weigh and dispense modules – and layer them onto existing workflows. Composable MES is additive – it supplements rather than replaces the paper master batch record.
3. Enterprise EBR slash MES. As described earlier, this remains the target architecture for fully integrated manufacturers with the capital and timeline for complete deployment. It is the most capable pathway and also the most demanding, substituting the paper MBR entirely
and requiring validated governance of the full production process. Choosing the right path. The question one should ask is, which approach fits my organisation today? A virtual pharmaceutical company has different challenges than a CDMO.
A mid-sized manufacturer has different priorities than a global enterprise. Successful review by exception starts with selecting the architecture that aligns with your operational reality. Are you ready to implement review by exception in your manufacturing process?
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Frequently Asked Questions
Mareana has helped numerous firms in the Pharmaceutical, Chemical, Medical Device, and Industrial Manufacturing industries.
No. Review by exception can be implemented through different technology pathways depending on a manufacturer’s operational maturity. These include Document Review Automation, Composable MES, and Enterprise EBR/MES.
Review by exception is a batch review approach where quality teams focus on data and records that require attention rather than manually reviewing every entry. Automated checks identify potential exceptions, allowing reviewers to investigate flagged information.
Paper-based manufacturers can use Document Review Automation to digitize paper or PDF batch records, extract critical data, and perform automated exception checks against predefined parameters. This can enable review by exception without requiring changes to a CDMO’s systems.
The three pathways are Document Review Automation, Composable MES, and Enterprise EBR/MES. Each supports a different level of manufacturing maturity, from paper-dependent operations to fully integrated manufacturing environments.
Document Review Automation works with existing paper or PDF batch records and can operate without replacing the current manufacturing systems. Enterprise MES with EBR digitizes and governs the production process more comprehensively but typically requires greater investment, implementation time, and organizational change.
Manufacturers should choose the approach that matches their current operational reality, technology maturity, capital availability, and implementation timeline. A virtual pharmaceutical company, CDMO, mid-sized manufacturer, and global enterprise may each require a different pathway.
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