21 CFR Part 11 Compliant : eInfotree Excel Module

eInfotree Excel Desktop

Spreadsheets are commonly used in support of critical GxP applications. Examples of these include:

Clinical trials
Testing of raw materials, in-process testing, finished goods testing
Manufacturing logs
Assay testing
Training records
Records required by predicate rules (GCP, GMP, GLP)

Studies show that spreadsheets are highly prone to errors due to their easy availability and ease of use. Spreadsheet errors, in a GxP environment, can lead to serious consequences including improper release of a batch, erroneous clinical trial results and such. Simply put, spreadsheets used in support of predicate rules must be 21 CFR Part 11 compliant to comply with FDA regulations.

Benefits

Store and use spreadsheets from a SharePoint Library
Store all audit trails, configurations and settings into an instance of SQL DB for automated backup, diverse reporting capability and added security.
No change in the user experience - spreadsheets can still be opened the way they were by simply double-clicking the file name.
No need to move the spreadsheets to a different location.
Simple and effective remediation of Excel Spreadsheets for 21 CFR Part 11 Compliance.
Save time and money by eliminating the need to migrate to a new system.
Quick and easy installation of software.
Automated and structured process provides confidence in spreadsheet controls and process integrity to aid in attestation.
A dedicated server is not required.
Easy to configure, use and maintain.
Reduced validation effort using an available validation package.

Features

Audit Trail

Tracks both user and administrator actions
Records date, time, user ID, full user name, cell location, action type, old value, and new value
Configurable reason field
Fully secure and protected
Audit trail of user logins, logouts, and invalid attempts

Electronic-Signatures

Includes the user id and printed name of signer, the date and time the signature was executed, and meaning associated with the signature
Meanings of e-signatures are configurable
Signature not performed during a single, continuous period of system access requires all e-signature components

Security

Allows configuration of users and passwords
Enforces minimum length and composition of passwords to ensure security and integrity
Password Aging - forces new password after a configurable period
Transaction safeguards include account lockout after configurable number of retries
Loss management procedures to electronically deauthorize passwords temporarily, and require a new password after reset

Overcoming 4 Challenges to the Use of GxP Compliant Spreadsheets

Today, spreadsheets are commonly used throughout the biopharmaceutical, pharmaceutical and other FDA-regulated industries. Spreadsheets are considered systems and when they impact data that affects product identity, strength, purity and safety, they must be validated and controlled. The purpose of this White Paper is to review the solution to four (4) common challenges when using spreadsheets to meet GxP quality requirements.

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Testimonials

"Charles River Labs (CRL) has implemented and is using the eInfotree Excel Desktop for over 2 years now. eInfotree has been deployed enterprise-wide in North America and Europe, and the scope of the implementation includes 17 sites (and counting) within Charles River with nearly 7,000 eInfotree Excel desktop client installations at these sites, using a centralized server model.

eInfotree has been a valuable tool in our Digital Transformation journey helping us to make our spreadsheets 21 CFR Part 11 compliant as well as adhering to our Data Integrity plan and governance. It has saved us hours of work that was earlier spent in verifying calculations, printing the spreadsheets and applying hand signatures, and then filing and storing all the printouts. It has also helped us in our audits since our spreadsheet controls are now automated with lower potential for human error. Resolving CAPA issues is now a breeze as the eInfotree audit trail provides an immediate history and timeline of any changes made. Furthermore, Charles River have now initiated the conversion of several paper forms into Excel forms, accelerating our digital efforts towards a paperless environment, applying not only further compliance but electronic approval of forms as well, significant paper reduction and increase efficiencies in form processing, archiving and retention. Overall, we estimate that eInfotree has reduced our costs by an estimated 20% in terms of the time and effort saved, while automating our data integrity and compliance processes.

The scalability and configurability of the product has been impressive, while the professionalism and responsiveness of CIMCON’s customer service team has been exemplary. It is clear to us that at CIMCON, the entire company is highly motivated and dedicated to ensure customer success, and it is not just a slogan. We look forward to working with them in the near future, on our Digital Transformation journey and Data Integrity initiatives."

Alain Fraser,

Director, Computerized Systems Validation at Charles River Laboratories

We are a pharmaceutical manufacturing company and we implemented the SaaS based eInfotree EDMS with eTraininfo Training Module provided by CIMCON earlier this year. I cannot say enough great things about the CIMCON Team. The team has been exceptional with maintaining frequent communication with our company for any questions we may have. CIMCON has also been very proactive in developing new features to fit our business-specific requirements and in an agreeable amount of time. I was impressed with the post implementation support that we received for any issues that arose after we went into production. Our issues were resolved in most cases over the phone. Our recent software upgrade went smoothly, thanks to the CIMCON team going into thorough detail about the changes we can expect to see.

The software has reaped us great benefits since its implementation. We have been extremely satisfied with the product, and have noticed a quicker streamlined process from the initiation of procedures to the subsequent training, in contrast to the manual process that we used before. The addition, the eTraininfo Training Module allows the training department to seamlessly transition a document from approval into training for all the affected users. The flexibility of the configurations to adapt to our company allowed us to rollout the system much quicker than expected without having to change our work processes. We were delighted that CIMCON offered the SaaS hosted service in contrast to supplying any on-premise hardware expenses that would’ve decelerated the implementation process. This technology also negated the need for capital expenses for the company so we were able to see a quicker ROI on the product.

I can say that this is certainly one of the most customer-driven companies that I have ever had the pleasure to work with, and I am excited to see what solutions the company will provide to us in years to come.

Quality Systems Specialist,

Pharmaceutical Company

We purchased CIMCON's eTraininfo and eInfotree Excel software about 2 years ago and couldn’t be happier with the results. Aside from keeping us Part 11 compliant, both solutions have made record keeping and reporting significantly easier and time efficient which is key in a regulated environment. The technical support response is always prompt and helpful in resolving any issues we encounter with CIMCON’s products.

21 CFR Part 11 Compliance for Spreadsheets