Still relying on excel spreadsheets & word documents to manage quality?

Pharmaceutical, Health Care, Life Science, and Biotech are few of the industries are operating under various quality and regulatory standard bodies like US FDA, MHRA, EMEA, WHO, TGA and CDSCO. As these drug manufacturing industries are delivering drug products to enhance the level of health of mankind, hence need to ensure the safety, efficacy, and quality of their products. So the importance of having a quality management system (QMS), document management system and training management system is very high and mandatory to implement. FDA has defined a Current Good Manufacturing Practices (cGMP) for these above-mentioned organizations as a disciplinary guideline to produce superior quality of drug products.

But still, most of the industries relying on traditional methods like using spreadsheets, Microsoft word documents for CAPA, deviations, change control, market complaints, training management, audit and vendor management, etc. Excel spreadsheets are the most cost-effective solution and where you can do plenty of activities in that but when there is a question comes about data integrity, version control, and transparency it has failed to deliver.

One of the biggest challenges these industries are facing for years is how to maintain, validate and manage the data integrity using excel spreadsheets in GMP areas

Here are the complexities and challenges associated with Word Documents and Spreadsheets:

• Not properly configured to enable different functions that provide alignment with data integrity requirements
• Manipulation of unprotected calculations, formulas and spreadsheet data
• When multiple people are updating and altering spreadsheets, there is no way to control access or keep track of users who edited what.
• Compliance and business risk
• Unable to design the required workflow process
• Required a lot of time, cost and effort
• Data available in multiple spreadsheets and sharing across the groups through emails
• Unable to produce dynamics reports, send notifications and reminders
• Unable to provide information on the go for proper decision making and interpretation
• Hard to consolidate the data coming from different departments of an organization
• No Audit trails on data changes, no traceability of workflow
• Unable to send email alerts, escalations, and notifications

In today’s world, technology now enabling companies are taking advantages of digital innovation strategies to implement the Electronic Quality Management System (EQMS) to automate their paper-based business process without relying on word or spreadsheets and significantly reduces the error-prone and mistakes if any.

AmpleLogic is helping various pharmaceutical and life sciences companies to streamline, improve the efficiency, tracking, and transparency of their quality management process by consolidating multiple types of audits, CAPA, deviations, complaints, training and document management in a centralized environment.