Get your manufacturing line compliant and help provide a safer and more transparent tomorrow.
For those that are in the pharmaceutical and life sciences industry, you're tasked with the production of often lifesaving medicines and equipment. While you may have a tried and true method, there's no better way to optimize your next batches than with the integration of digital solutions. These will help not only with optimizations – but also will help to keep you ahead of the regulations that come up.
Our system helps to be able to build out the right type of systemic approach to your pharmaceutical and life sciences manufacturing needs. It will help to sync up the facilities and manufacturing equipment and ensure proper calibration. At the same time, it helps with easy access to staff training. Finally, it helps to digitally implement the right procedure and material management and composition to keep all the batches uniform
Help your manufacturing process follow ALCOA+ principles once you integrate our quality management system. You'll be able to follow all the necessities of digitizing records and make them attributable, legible, contemporaneous, original, and accurate. At the + of ALCOA and also get ahead of the compliance game with complete, consistent, enduring, and easy-to-access data points, wherever you may be on the floor
Reduce batch deviation
Get both compliant and optimized with EBRs. These help to track each batch that is manufactured throughout the entire manufacturing and batch creation process. The information is there to adhere to compliance, but it also helps with identifying room for improvement and wherever the pain points may show up. In addition, EBRs will help with the data reporting and analytics to provide actionable information, as all data points are captured here.
Product traceability via Electronic Batch Records
See the power of our system by having a rich data integrity system built in. Track every aspect of the manufacturing process, from the blend of materials that go into a pharmaceutical drug to the cleaning checklist after a batch production round. Maintain a consistent production scheme so that every batch that goes out is identical to the previous batch and the next batch in the queue.
Having Electronic Batch Records (EBRs) helps not only comply with 21 CFR Part 11 but will do wonders for your overall processes.
Collect electronic signatures from key staff to keep the process moving without the need to have everyone on site to continue the batch production.
Spot Production Bottlenecks
Since EBRs captures the entire batch process on a digital level, it is easy to spot any type of bottlenecks that may come up and can be easily remedied while at the same time producing one of the best digital audit trails possible.
Beyond compliance and efficiency comes enhanced security as electronic batch records are easily auditable, which helps in case something may not go the best way and helps to keep a consistent batch production to happen.
Product specific instructions
With greater customization comes the need for detailed instructions. Yet it’s nearly impossible to ensure that paperwork instructions are accurate for the ever-growing number of combinations. Digital work instructions can tackle this challenge by showing product variant specific instructions faster.
Visual Aids and Images
By using visuals, businesses can ensure that the DWIs are accessible for employees with different learning styles. Each step in a procedure can be accompanied by visuals that accurately display the tasks and actions required.
With DWIs, you never have to worry about outdated information. The ability to update digital instructions in real-time ensures that no process is at risk. This can bring greater clarity and certainty to an ever-complex workflow – and new updates can be sent out immediately as changes are made.
Guide operators with digital Work instructions
Get your factory smart and operate at Industry 4.0 levels. Digital work instructions help develop a single truth source for the entire production batch cycle. Besides increased efficiencies due to reduced paper-based processes and quality due to clear instructions to employees, it also helps those same employees get upskilled to help improve engagement and overall output.
A Clear Approach to Capa & Nonconformances
Root out the problem when issues arise and create compliant CAPA workflows. Stay ahead of the auditors by finding out these issues before they become serious problems while at the same time developing a clear routing path that escalates to the right levels of management.
Visibility across your organization
Work to track and trace any problems to see if they're a one-off issue or part of a larger defect and eliminate it at the source.
Record problems right where they happen.
Issues may be noted quickly and allocated to the appropriate persons thanks to the integrated picture documentation. This always guarantees that the proper system is investigated.
Automated routing and escalation process
Avoid any lag in resolution and have tasks and notifications routed automatically to the critical decision-making party members and notify all team members.
Plan, schedule, review
Incorporate a maintenance schedule and checklist to ensure machinery is always checked as per regulations and track all these through a log report.
Easily track & receive notifications of completed, in-progress or overdue audits, along with approvals and rejections.
Scoring & Dashboards
Be able to track everything in real-time through executive-style dashboards and reports. Leverage advanced formulas to deliver complex calculations and an automatic scoring that will be displayed in the reports.
Good Manufacturing Practice (GMP) Inspection Checklists
Audits can happen to the best in the industry and tend to be routine. So get ahead by having a completely digital checklist that tracks the necessary daily tasks that need to be completed to ensure a clean and hygienic manufacturing factory. At the same time, build internal audits consistently that would follow what an external audit would look like, with fully customizable checklists that can be assigned to specific teams and coworkers.
Track experience with our compentency matrix
Give your manufacturing business the ability to build out a competency matrix. This will give you a complete overview of your manufacturing skill set based on the current employees and where improvements can be made. Then you'll be able to upskill those employees with on-the-job training to improve retention rates and employee satisfaction. All the while updating the competency matrix until it's well-rounded and robust.
Your employees can complete training on the go and adjust their learning schedules while you track their progress.
Track performance and get an overview of the skills and competencies of your learners.
Supervisors can view progress and completion based on each individual learner. Get an overview of the data you need via extensive reports.
Data integrity arrangements ensure that the accuracy, completeness, content and meaning of data is retained throughout the data lifecycle.
Soc 2 compliant
Our SOC 2 certificate shows proof of trust and assurance to your production data by having implemented appropriate measures for security, confidentiality, privacy, availability, and integrity of customers' data.
We have built a thorough set of organizational and technical safeguards that protect the safety of your data. We have clear internal regulations, a detailed onboarding procedure for staff, and give regular security training.
Data integrity: 21cfr part 11 compliant
Have the ability to pass any and every audit with a complete historical track record, as well as every update and electronic signature easily able to be verified, tracked, and traced. When you work with our platform, you'll see how fast you can get yourself 21 CFR part 11 compliant, follow ALCOA+ principles, and get yourself operating under cGMP rules and regulations.