Lead the business forward with self-auditing electronic batch records. With quality and inventory entries verified in real-time, DataNinja helps you automate quality, with traceability dock to dock.
Track inventory with live quality controls, location and quantity details specific to each pallet, bag, or drum.
Stop documenting costly errors, prevent them before they happen!
Know when to schedule bulk blends and packaging runs to keep ahead of customer demand.
Covered. Finally a system that supports tracking units most important to your process, while working with supplier packaging sizes.
Seamlessly connect your new electronic batch record system with your scales for digital dispensing and pre-weigh barcoding.
Deep connectivity with your finance and fulfillment systems. Remove the gridlock between your Quality, Finance and Production teams.
Ready to ditch paper and shared spreadsheets?
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| Regulation | CFR 21 Part 111 Requirement Summary | How DataNinja Provides Compliance |
|---|---|---|
| §111.20 §111.155 §111.160 §111.165 §111.170 §111.370 §111.425 §111.460 §111.155 | A control system that prevents any type of material mix-up and enables quality status control over each component Lot through every step of your process. | DataNinja comes standard with a warehouse automation system designed for the way Part 111 regulated manufacturers need to work with material. DataNinja electronically tracks the location, quantity and quality control status of every uniquely identified Lot of material. Manual and painfully inaccurate material management practices are automated away with DataNinja. Already using a warehouse management system with barcodes? No problem , integrate it with your electronic workflows in DataNinja for a seamless manufacturing traceability system. |
| §111.610 §111.350 §111.255 §111.605 | FDA has required that you keep quality records easily retrievable for at least 1 year past shelf life or 2 years after distribution. All quality documentation (MMR, BPR, equipment logs, receiving logs, COAs, distribution records, etc. must be protected with backup programs that prevent alteration and/or loss. Electronic Records are acceptable as long as they are compliant with CFR 21 part 11. | Cloud-based electronic batch record software enables your Dietary Supplement manufacturing quality records to be instantly searchable and retrievable. DataNinja software is CFR 21 part 11 compliant – with the approved access security, audit trail, and user authentication required for part 111 record keeping compliance. Your data is safe with redundant backups and high profile encryption in a professional data center. |
| §111.255 §111.260 §111.415 §111.475 | For each batch you produce, you must complete a Batch Production Record (BPR) that corresponds to the applicable MMR, and assigned a Batch, Lot or Control number unique to the batch of finished goods. The BPR must include complete information relating to the production and control of each batch. Activities must be documented at the time of performance, and all entries must be approved by Quality Control including:
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Electronic Batch records completed in DataNinja have all the components of a part 111 compliant Batch Production Record. DataNinja does the heavy lifting to ensure that:
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| §111.250 §111.300 §111.350 | Record equipment calibration and have Quality control personnel regularly review equipment logs of calibrations, checks, and repairs. | Electronic Equipment management for FDA regulated manufacturing comes with DataNinja out of the box. Not only does DataNinja allow you to record equipment usage, and control equipment operational status, but it also provides an electronic workflow for your teams to request and record equipment maintenance so your up-time is maximized. |
| §111.700 §111.105 §111.123 §111.205 §111.550 | Prepare and follow a Master Manufacturing Record (MMR) for each unique formulation of Dietary Supplement and each batch size for each formulation. Quality control personnel must review and approve all MMR creations and modifications. The FDA has identified at least 13 things that each and every valid MMR must have. | Build, store, and version control your Part 111 compliant MMRs with permission based access directly within DataNinja. Once you have created MMR templates it is easy to transfer and customize specifications and standard batch sizes within minutes. |
| §111.255 | Each time you manufacture a batch of dietary supplements you must prepare a Batch Production Record (BPR) that accurately follows the MMR associated with all product specifications and batch size. | When you schedule production in DataNinja’s calendar tool, he appropriate electronic Batch Production Record is generated and queued for production. Approved Quality control personnel and your operations workforce have access to the electronic document the moment they need to record information from any internet connected device. |
| §111.410 §111.530 §111.830 | You must be able to determine the complete manufacturing history and control of the packaged and labeled dietary supplement through distribution. The FDA requires you to collect and hold reserve samples with at least twice the quantity for all testing associated with the finished good. If there is ever a concern that your finished product does not meet its specifications, you must conduct an investigation of your manufacturing process for each affected batch. | Normally traceability information is spread across desperate tracking logs, batch records, accounting software and inventory management spreadsheets. Pulling all the paper data together and then synthesizing insights out of a particular lot’s traceability story when you need it is extremely costly. DataNinja connects all your traceaibitlty and quality data so that you get straight to the answers you need when you need them. Search a raw material or finished good lot number and see all related quality records, approval histories, inspection documentation, and related shipments all on a single page in DataNinja. |
| §111.700 §111.750 §111.155 §111.180 | Part 111 requires you to specify identity and component specifications for each unique Lot within each unique shipment you receive. You must establish a process that quarantines material until Quality Control personnel have released it for use. When receiving material you must conduct both visual and scientific tests to ensure identity, strength and composition. If a supplier has been qualified you may accept their COA provided you have an established schedule to regularly audit the supplier material to ensure it matches claims in their COA. | Print traceability barcodes right out of DataNinja and then complete electronic inspections that are created specifically for each material. Upload documents and snap pictures from a mobile device. All information is associated with the lot number you assign the material and is retrievable within DataNinja’s CFR 21 part 11 quality records search. |
| §111.120 §111.420 | Part 111 requires implementation of quality control operations in manufacturing, packaging, labeling and holding operations. Defined Roles must have distinct and separate permissions, along with escalation procedures that align with MMR specifications. | Granular permissions and access control is easy to set as a DataNinja admin user. You can control which groups of users have authority to sign off on a specific type of deviation. It is also easy to organize on a per-user basis which employees should have access to preform activities within your manufacturing quality and traceability system. |
| §111.700 §111.113 §111.410 §111.650 §111.750 | Quality control operations must have established in-process specifications for any point step or stage in your process along with action plans for an deviation from acceptable thresholds or any unanticipated occurrence. | Industry best practice global escalations can be setup within DataNinja based on how you design your MMRs. For processes or products that require special attention assign trackable attributes and let DataNinja watch for user entered data to meet specifications. If anything is outside of parameters DataNinja automatically escalates the issue to a quality control dashboard. This means your quality personnel will have real-time access to BPR issues. Dataninja greatly reduces document review times by combining automatic checks when real-time alerts. |