Pharmaceutical MES, laboratory and equipment data integrations
The operator and quality worker receive linked production, equipment, and laboratory records. Missing approvals and corrections are visible to be reviewed.
Production steps and approvals are stored separately from the specific task, version of the instruction used and unresolved deviations. The quality team collects and revises the records needed for batch review longer.
How the solution works
- The MES used provides an approved production task, instruction and record identifier.
- Equipment and laboratory facts shall be linked to the appropriate record in accordance with the approved transfer rules.
- Missing data, deviations and incomplete confirmations are transmitted to the responsible reviewer.
- Accepted corrections and endorsements are returned to the source that controls them, maintaining the change history.
- The quality review receives an up-to-date record and its exceptions; the final evaluation is carried out by authorized specialists of the manufacturer.
Key challenges
- Production data is recorded too late
- The electronic batch record is not seamless
Solution capabilities
Execution instruction
The user sees a sequence of actions and a basis for use approved for a specific batch or product.
Registration of facts
The facts of materials, equipment, time and process are linked between the approved sources and the MES record according to the agreed granularity.
Initial entry and correction
The correction is transmitted to the input data system, preserving the origin of the record and the replacement history. The viewer sees if this system has accepted the correction.
Electronic Approvals
The system that controls the validation receives what and what record it has approved and what significance the validation has. Missing endorsements are returned to its responsible employees.
Exceptions to the review
The deviation, missing data and incomplete validation are clearly presented to the reviewer.
Business context
- Production data is recorded too late
- Production steps and approvals are stored separately from the specific task, version of the instruction used and unresolved deviations. The quality team collects and revises the records needed for batch review longer.
- The electronic batch record is not seamless
- Records of production, equipment, environment, laboratory, materials and deviations are collected in several validated and non-mandated systems. The batch review has to combine evidence for a long time, and the missing, corrected or unassociated record is difficult to spot in time.
- The delivery plan is based on batch data produced
- The produced batch can wait for the missing record or for an undone review. Early visible defects in the documents allow them to be handled until the planned delivery. The customer can be more accurately explained the state of readiness, and the decision on the release of the batch is made by the specialists responsible for this.
Core features
- Execution instruction
- Registration of facts
- Initial entry and correction
- Electronic Approvals
- Exceptions to the review
Key integrations
- Manufacturing Execution System (MES) in use
- Approved production tasks, execution records and their revision states.
- Laboratory Information Management System (LIMS)
- The relationship between sample, result and its validation.
- Quality management system (QMS)
- The states of deviation, inquiry and quality decision.
- Enterprise resource planning system (ERP)
- Tasks, Product and Materials Identifiers.
- Approved Equipment and Environment Data Sources
- Facts with time and the connection of origin are necessary for the process.
- Production planning process
- The task is approved and the actual fact of execution is returned.
Potential impact (%)
The ranges indicate an illustrative relative change in the metric under the stated assumptions. Results depend on the starting position and actual use of the solution. Percentages for different metrics must not be added together.
batch Record Administration Work
12–36%Decreasing
This illustrative scenario assumes that 30-60% of manual data entry and handover work can be addressed. That share is assumed to fall by 40-60%. Company data is needed to verify both the addressable workload and the resulting change.
Active rewriting, searching and correction are measured for batches of equal record volume.
Time of collection of missing batch records
12–36%Decreasing
This illustrative scenario assumes that 30-60% of manual data entry and handover work can be addressed. That share is assumed to fall by 40-60%. Company data is needed to verify both the addressable workload and the resulting change.
Active work on finding, transmitting and specifying missing evidence is measured for batches of equal review scope. The duration of the mandatory study is not included; incomplete additions are reported separately.
Conditional calculation scenarios. The assumptions have not been validated against client measurements.
When this solution is relevant
- Batch preview stalls due to missing actions, data connection, or obscure history of record change.
- The digital execution record is completed, but no open exceptions are passed on to the next assessor.
Implementation requirements
For electronic batch records, data sources, validation rights, revision history and operational continuity are defined. The transition from the records used is planned according to the purpose of the system and risk, preserving the availability of historical data and the necessary evidence of suitability.
Further development options
- More verified review rules that distinguish the employee from the attention-seeking records
- Development of Record Availability and Recovery Tests