It’s easy to get your Spreadsheet based Test Methods under control quickly with our innovative approach to Creating, Qualifying, Completing and Approving these critical testing records.
The Parenteral Drug Association's Technical Report 80 (PDA TR80) issued at the end of 2018 indicates the current expectations for assuring data integrity which set a much higher bar to assure accurate and complete records then every before.
Using your own Spreadsheet Content or our industry tested templates, you will immediately save time and increase compliance by deploying qualified TestSheets for completion by your analysts. Review times are minimized by immediate notification of Reviewers once Testing is complete.
More time is saved when Testers and Reviewers provide approval , using the latest technology to apply 21 CFR Part 11 compliant 2 Factor Authentication.
Always up to Date: The TestSheet-Manager application is constantly maintained. Upgrades to the most current versions of Hardware and Software included at no extra cost. E-mail notifications assure timely awareness to quality & compliance related issues. Two Factor Authentication using Mobile Technology from Twilio®, providing unprecedented security and ease of use. Highly scalable: Serves companies large and small; Subscriptions scale up or down to fit any size business, allowing rapid and cost effective solutions. No Internal Footprint; Dedicated servers, network equipment, and physical space is all located in our SSAE-16 compliant data centers, providing you with logical and physical security at 99.999% up time.
Part 11 compliant signature capability.
The Creation Phase allows you to use your existing spreadsheets and place them in workbooks with all of the necessary controls to be compliant with Data Integrity requirements.
Creating your compliant TestSheets just got a whole lot easier. After adding your existing Spreadsheet into a controlled Workbook, the unused fields are set to locked and the sheet is then protected.
The new Workbook is now ready for Qualification.
Qualifying your TestSheet allows you to reuse the approved Workbook as a Qualified Template for each subsequent test that uses this method.
Qualify your TestSheets by performing a test against a known standard. Compare the results and if everything meets the standard, Approve the TestSheet and submit it to the Qualified TestSheet Library for use as a template on the next sample.
Using the Test Request Form, select your Method ID(s) and one or more new TestSheets are created for you in the Result Testsheet Library.
Complete your TestSheet(s) by capturing your data directly into the spreadsheet. The qualified formula already in the sheet cannot be modified.
All actions are captured in the Audit Trail automatically with appropriate UserID, date/time stamp and reasons.
Using your Smartphone, approve your TestSheets as the Tester or Reviewer.
Signing your Testsheet(s) is now much easier. The tester and reviewer each may sign using our innovative Smartphone App for 2 factor Authentication.
All signing actions are captured in the Audit Trail. The individual Sheets and entire Workbook are locked after signing.
Staffing and Outsourced Services: DCS is a full service partner, providing staffing options such as fully outsourced services and Temporary contractor support while you come up to speed.
Data Integrity Assessment and System Validation: DCS can provide your company with analysis and consulting services to augment your Quality and Compliance staff related to Data integrity Assessments using the latest PDA TR 80 guidelines and Agile Computer Systems Validation.
Migration: Many customers have existing quality and business platforms or older versions of software. Working with our partners, DCS can help you develop a strategy for migration, outline the risks, and facilitate migration activities that will allow your company to continue to evolve.
Integration with other Applications: DCS, along with our extensive network of partners, can integrate our applications into your existing systems.
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