Is your FDA compliance process as efficient as it could be?

Companies spend thousands on FDA 21 CFR Part 11 compliance. How much time and money could you save with a better Electronic Batch Records (ERB) system?

Learn about compliance complexity

Learn about cost saving opportunities

Process-Manager-Mobile-header-2

Is your FDA compliance process as efficient as it could be?

Companies spend thousands on FDA 21 CFR Part 11 compliance. How much time and money could you save with a better Electronic Batch Records (ERB) system?

Learn about compliance complexity

Learn about cost saving opportunities

FDA-compliance

Compliance can be complex and expensive.

 

Managing compliance can cost organizations thousands, even millions, in resources and staff time.

According to the Food and Drug Administration (FDA) Good Manufacturing Practice (xGMP) 21 CFR Part 11 compliance can cost small companies (20-500 employees) $184,000 per year while larger companies can spend millions.1

Most organizations are unhappy with their current solution because it lacks clear, comprehensive reporting and/or real-time visibility. As complex as compliance is currently, most managers expect an increase in regulations moving into the future. Compliance Managers are looking for a way to simplify regulatory compliance that provides a real-time and comprehensive view of core processes.

1 Source: https://www.naturalproductsinsider.com/manufacturing/cost-gmp-compliance

53% of compliance managers believe their reporting system lacks a comprehensive view of compliance.

75% of compliance managers believe their reporting system lacks real-time visibility.

61% of compliance managers expect compliance budgets to increase. This has increased from 53% in 2017.

75% of compliance manager expect regulations to increase, with 26% of those expecting significant increases.

How can we reduce compliance costs and complexity?

FDA Compliant Batch Reporting Software

Cloud-based, Enterprise.

21 CFR Part 11 | HACCP | SQF.

FDA Compliant Batch Reporting Software

Cloud-based, Enterprise.

21 CFR Part 11 | HACCP | SQF.

Batching-EBR
BATCHING & PRE-PRODUCTION

Get to production faster.

A common waste in the batching processes is re-entering the same information on multiple forms. Production and QA staff will also walk to-and-from the lab with batch samples and forms that require signatures. Data capture in ERP systems can also be slow, complex and arduous.

SOLUTION: Save time by automating workflows and approvals.

Process-Checks-EBR
PRODUCTION QUALITY CHECKS

Do your checks tell the whole story?

Using paper documentation can cause errors, delays and other forms of waste. Some ERP systems can be used for quality checks, but are too complex for floor workers and not very accessible. Ideally, your operators should be focused more on machine operation and less on collecting quality samples. The optimal solution requires less operator time and collects better, richer data.

SOLUTION: Use intuitive and efficient data collection tools.

FDA-Post-Production-Filing-Cabinets
POST-PRODUCTION DOCUMENTATION

Avoid data and document management costs.

Batch Reporting can generate a lot of paperwork. Paper documents are costly to store and require manual data inputting into spreadsheets or ERPs. It can also be hard to detect if critical data has been missed. Quality managers can find themselves spending more time managing document quality than product quality. If the post-production stage is delayed, the product will be shipped long before issues are found.

SOLUTION: Automate reporting, document processing, and real-time alerts.

FDA-Audit-3
AUDITS

Audits happen. Wasted time and fines don't have to.

Physical document storage adds frustration and complexity to audits - for your staff, and for the auditor. Manual reentry of data from paper form to a spreadsheet provides opportunities for human error. Any missed checks and errors can cost your company 6 figure fines. Why take the risk?

SOLUTION: Automatically digitize batch reports.

How much do you spend on Compliance Management?

FDA Compliant Batch Reporting Software

Cloud-based, Enterprise.

21 CFR Part 11 | HACCP | SQF.

FDA Compliant Batch Reporting Software

Cloud-based, Enterprise.

21 CFR Part 11 | HACCP | SQF.

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